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A Study of the Safety, Tolerability, and Effects of Cobimetinib and GDC-0994 in Patients With Locally Advanced or Metastatic Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02457793
Recruitment Status : Completed
First Posted : May 29, 2015
Results First Posted : August 24, 2018
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-Small Cell Lung Cancer, Metastatic Colorectal Cancer, Metastatic Non Small Cell Lung Cancer, Metastatic Cancers, Melanoma
Interventions Drug: Cobimetinib
Drug: GDC-0994
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Not Assigned COB 20 mg + GDC 200 mg COB 40 mg + GDC 200 mg COB 80 mg + GDC 200 mg COB 80 mg + GDC 400 mg COB 100 mg + GDC 200 mg
Hide Arm/Group Description One participant was assigned to receive intermittent cobimetinib 80 milligrams (mg) + GDC 0994 200 mg) and did receive study drug. However, the participant diary was not returned, and the site was unable to document study dose administration. Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off. Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off. Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off. Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off. Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Period Title: Overall Study
Started 1 5 3 5 4 6
Completed 0 1 0 0 0 0
Not Completed 1 4 3 5 4 6
Reason Not Completed
Reason not specified             0             0             0             1             1             1
Withdrawal by Subject             0             4             2             2             2             2
Adverse Event             0             0             0             1             0             0
Physician Decision             1             0             1             1             1             3
Arm/Group Title Not Assigned COB 20 mg + GDC 200 mg COB 40 mg + GDC 200 mg COB 80 mg + GDC 200 mg COB 80 mg + GDC 400 mg COB 100 mg + GDC 200 mg Total
Hide Arm/Group Description One participant was assigned to receive intermittent cobimetinib 80 milligrams (mg) + GDC 0994 200 mg) and did receive study drug. However, the participant diary was not returned, and the site was unable to document study dose administration. Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off. Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off. Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off. Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off. Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off. Total of all reporting groups
Overall Number of Baseline Participants 1 5 3 5 4 6 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants 5 participants 3 participants 5 participants 4 participants 6 participants 24 participants
48.0  (9999) 53.0  (11.5) 57.3  (11.0) 51.6  (14.2) 52.3  (5.6) 59.7  (11.5) 54.6  (10.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 5 participants 3 participants 5 participants 4 participants 6 participants 24 participants
Female
0
   0.0%
5
 100.0%
3
 100.0%
4
  80.0%
2
  50.0%
3
  50.0%
17
  70.8%
Male
1
 100.0%
0
   0.0%
0
   0.0%
1
  20.0%
2
  50.0%
3
  50.0%
7
  29.2%
1.Primary Outcome
Title Number of Participants With Dose-Limiting Toxicities (DLTs)
Hide Description DLTs include symptoms considered by the investigator to be possibly related to study drug.
Time Frame 28 days (Cycle 1)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants.
Arm/Group Title Not Assigned COB 20 mg + GDC 200 mg COB 40 mg + GDC 200 mg COB 80 mg + GDC 200 mg COB 80 mg + GDC 400 mg COB 100 mg + GDC 200 mg
Hide Arm/Group Description:
One participant was assigned to receive intermittent cobimetinib 80 milligrams (mg) + GDC 0994 200 mg) and did receive study drug. However, the participant diary was not returned, and the site was unable to document study dose administration.
Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Overall Number of Participants Analyzed 1 5 3 5 4 6
Measure Type: Count of Participants
Unit of Measure: Participants
Dermatitis Acneiform
1
 100.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Rash
1
 100.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Diarrhoea
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
Myocardial infarction
0
   0.0%
0
   0.0%
0
   0.0%
1
  20.0%
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Percentage of Participants With at Least One Adverse Event
Hide Description An adverse event is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
Time Frame Up to 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants.
Arm/Group Title Not Assigned COB 20 mg + GDC 200 mg COB 40 mg + GDC 200 mg COB 80 mg + GDC 200 mg COB 80 mg + GDC 400 mg COB 100 mg + GDC 200 mg
Hide Arm/Group Description:
One participant was assigned to receive intermittent cobimetinib 80 milligrams (mg) + GDC 0994 200 mg) and did receive study drug. However, the participant diary was not returned, and the site was unable to document study dose administration.
Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Overall Number of Participants Analyzed 1 5 3 5 4 6
Measure Type: Number
Unit of Measure: percentage of participants
100 100 100 100 100 100
3.Primary Outcome
Title Percentage of Participants With at Least One Adverse Event of Special Interest
Hide Description AESIs were graded per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v4.0. AESIs included the following: Grade ≥ 1 retinal vein occlusion; Grade ≥ 2 visual disturbances (including events suggestive of serous retinopathy); Grade ≥ 3 rash for > 7 days; Grade ≥ 3 diarrhea for > 3 days; Grade ≥ 2 left ventricular ejection fraction (LVEF) decrease; Grade 3 hepatotoxicity; any dose-limiting toxicity (DLT); cases of potential drug-induced liver injury that include an elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (AST > 3 × baseline value [and above the upper limit of normal, ULN]) in combination with either an elevated bilirubin ( > 2 × ULN) or clinical jaundice; or suspected transmission of an infectious agent by either study drug.
Time Frame Up to 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants.
Arm/Group Title Not Assigned COB 20 mg + GDC 200 mg COB 40 mg + GDC 200 mg COB 80 mg + GDC 200 mg COB 80 mg + GDC 400 mg COB 100 mg + GDC 200 mg
Hide Arm/Group Description:
One participant was assigned to receive intermittent cobimetinib 80 milligrams (mg) + GDC 0994 200 mg) and did receive study drug. However, the participant diary was not returned, and the site was unable to document study dose administration.
Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Overall Number of Participants Analyzed 1 5 3 5 4 6
Measure Type: Number
Unit of Measure: percentage of participants
100.0 100 33.3 60.0 75.0 50.0
4.Primary Outcome
Title Percentage of Participants With at Least One Serious Adverse Event (SAE)
Hide Description A SAE is any experience that: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is medically significant.
Time Frame Up to 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants.
Arm/Group Title Not Assigned COB 20 mg + GDC 200 mg COB 40 mg + GDC 200 mg COB 80 mg + GDC 200 mg COB 80 mg + GDC 400 mg COB 100 mg + GDC 200 mg
Hide Arm/Group Description:
One participant was assigned to receive intermittent cobimetinib 80 milligrams (mg) + GDC 0994 200 mg) and did receive study drug. However, the participant diary was not returned, and the site was unable to document study dose administration.
Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Overall Number of Participants Analyzed 1 5 3 5 4 6
Measure Type: Number
Unit of Measure: percentage of participants
100.0 40.0 66.7 60.0 50.0 66.7
5.Primary Outcome
Title Percentage of Participants With Laboratory Abnormalities
Hide Description

Laboratory abnormalities were graded per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v4.0.

SGPT/ALT - serum glutamic-pyruvic transaminase/alanine aminotransferase; SGOT/AST - serum glutamic oxaloacetic transaminase/aspartate aminotransferase

Time Frame Up to 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants. Data are reported for evaluable participants.
Arm/Group Title Not Assigned COB 20 mg + GDC 200 mg COB 40 mg + GDC 200 mg COB 80 mg + GDC 200 mg COB 80 mg + GDC 400 mg COB 100 mg + GDC 200 mg
Hide Arm/Group Description:
One participant was assigned to receive intermittent cobimetinib 80 milligrams (mg) + GDC 0994 200 mg) and did receive study drug. However, the participant diary was not returned, and the site was unable to document study dose administration.
Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Overall Number of Participants Analyzed 1 5 3 5 4 6
Measure Type: Number
Unit of Measure: percentage of participants
Albumin Number Analyzed 1 participants 5 participants 3 participants 5 participants 4 participants 6 participants
100.0 80.0 66.7 100.0 100.0 83.3
Alkaline Phosphatase Number Analyzed 1 participants 5 participants 3 participants 5 participants 4 participants 6 participants
100.0 80.0 66.7 80.0 75.0 50.0
SGPT/ALT Number Analyzed 1 participants 5 participants 3 participants 5 participants 4 participants 6 participants
0.0 60.0 0.0 60.0 25.0 33.3
SGOT/AST Number Analyzed 1 participants 5 participants 3 participants 5 participants 4 participants 6 participants
100.0 100.0 66.7 60.0 75.0 50.0
Calcium Number Analyzed 1 participants 5 participants 3 participants 5 participants 4 participants 6 participants
100.0 20.0 33.3 80.0 100.0 33.3
Creatinine Number Analyzed 1 participants 5 participants 3 participants 5 participants 4 participants 6 participants
100.0 100.0 100.0 100.0 100.0 50.0
Blood Glucose, Fasting Number Analyzed 1 participants 4 participants 2 participants 3 participants 3 participants 1 participants
0.0 100.0 100.0 0.0 66.6 100.0
Gamma Glutamyl Transferase Number Analyzed 1 participants 5 participants 3 participants 5 participants 4 participants 6 participants
100.0 60.0 66.7 60.0 75.0 50.0
Glucose Number Analyzed 1 participants 5 participants 3 participants 5 participants 3 participants 6 participants
0 20.0 0.0 0.0 0.0 0.0
Hemoglobin Number Analyzed 1 participants 5 participants 3 participants 5 participants 4 participants 6 participants
100.0 60.0 66.7 100.0 75.0 66.7
Lymphocytes, Absolute Number Analyzed 1 participants 5 participants 3 participants 5 participants 4 participants 6 participants
100.0 40.0 33.3 60.0 50.0 16.7
Magnesium Number Analyzed 1 participants 5 participants 3 participants 5 participants 4 participants 6 participants
100.0 40.0 66.6 20.0 50.0 16.7
Phosphorus Number Analyzed 1 participants 5 participants 3 participants 5 participants 4 participants 6 participants
0.0 20.0 0.0 0.0 25.0 0.0
Platelets Number Analyzed 1 participants 5 participants 3 participants 5 participants 4 participants 6 participants
0.0 20.0 33.3 40.0 50.0 33.3
Potassium Number Analyzed 1 participants 5 participants 3 participants 5 participants 4 participants 6 participants
0.0 40.0 66.7 40.0 25.0 33.3
Sodium Number Analyzed 1 participants 5 participants 3 participants 5 participants 4 participants 6 participants
0.0 60.0 33.3 0.0 50.0 16.7
Bilirubin Number Analyzed 1 participants 5 participants 3 participants 5 participants 4 participants 6 participants
100.0 20.0 0.0 0.0 25.0 0.0
Uric Acid Number Analyzed 1 participants 5 participants 3 participants 5 participants 4 participants 6 participants
0.0 20.0 0.0 0.0 25.0 16.7
White Blood Cell Count Number Analyzed 1 participants 5 participants 3 participants 5 participants 4 participants 6 participants
0.0 20 0.0 20.0 25.0 33.3
6.Primary Outcome
Title Mean Change From Baseline in Diastolic Blood Pressure
Hide Description [Not Specified]
Time Frame Baseline, up to 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants. Data are reported for evaluable participants.
Arm/Group Title Not Assigned COB 20 mg + GDC 200 mg COB 40 mg + GDC 200 mg COB 80 mg + GDC 200 mg COB 80 mg + GDC 400 mg COB 100 mg + GDC 200 mg
Hide Arm/Group Description:
One participant was assigned to receive intermittent cobimetinib 80 milligrams (mg) + GDC 0994 200 mg) and did receive study drug. However, the participant diary was not returned, and the site was unable to document study dose administration.
Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Overall Number of Participants Analyzed 0 5 3 2 1 5
Mean (Standard Deviation)
Unit of Measure: millimeters of mercury (mmHg)
-4.2  (7.6) -4.3  (11.8) -0.5  (7.8) 29.0 -13.2  (15.9)
7.Primary Outcome
Title Mean Change From Baseline in Lean Body Mass
Hide Description [Not Specified]
Time Frame Baseline, Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
All participants. Data are reported for evaluable participants.
Arm/Group Title Not Assigned COB 20 mg + GDC 200 mg COB 40 mg + GDC 200 mg COB 80 mg + GDC 200 mg COB 80 mg + GDC 400 mg COB 100 mg + GDC 200 mg
Hide Arm/Group Description:
One participant was assigned to receive intermittent cobimetinib 80 milligrams (mg) + GDC 0994 200 mg) and did receive study drug. However, the participant diary was not returned, and the site was unable to document study dose administration.
Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Overall Number of Participants Analyzed 0 4 1 5 3 2
Mean (Standard Deviation)
Unit of Measure: kilograms (kg)
0.25  (1.26) -2.00 -0.20  (1.30) -4.33  (5.77) 0.00  (1.41)
8.Primary Outcome
Title Mean Change From Baseline in Pulse Rate
Hide Description [Not Specified]
Time Frame Baseline, up to 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants. Data are reported for evaluable participants.
Arm/Group Title Not Assigned COB 20 mg + GDC 200 mg COB 40 mg + GDC 200 mg COB 80 mg + GDC 200 mg COB 80 mg + GDC 400 mg COB 100 mg + GDC 200 mg
Hide Arm/Group Description:
One participant was assigned to receive intermittent cobimetinib 80 milligrams (mg) + GDC 0994 200 mg) and did receive study drug. However, the participant diary was not returned, and the site was unable to document study dose administration.
Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Overall Number of Participants Analyzed 0 5 3 2 1 5
Mean (Standard Deviation)
Unit of Measure: beats per minute
20.4  (32.7) 16.7  (22.7) 15.5  (9.2) 43.0 12.2  (21.6)
9.Primary Outcome
Title Mean Change From Baseline in Respiratory Rate
Hide Description [Not Specified]
Time Frame Baseline, up to 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants. Data are reported for evaluable participants.
Arm/Group Title Not Assigned COB 20 mg + GDC 200 mg COB 40 mg + GDC 200 mg COB 80 mg + GDC 200 mg COB 80 mg + GDC 400 mg COB 100 mg + GDC 200 mg
Hide Arm/Group Description:
One participant was assigned to receive intermittent cobimetinib 80 milligrams (mg) + GDC 0994 200 mg) and did receive study drug. However, the participant diary was not returned, and the site was unable to document study dose administration.
Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Overall Number of Participants Analyzed 0 5 3 2 1 5
Mean (Standard Deviation)
Unit of Measure: breaths per minute
1.6  (3.6) 0.3  (0.6) 0.0  (0.0) 2.0 1.6  (3.6)
10.Primary Outcome
Title Mean Change From Baseline in Systolic Blood Pressure
Hide Description [Not Specified]
Time Frame Baseline, up to 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants. Data are reported for evaluable participants.
Arm/Group Title Not Assigned COB 20 mg + GDC 200 mg COB 40 mg + GDC 200 mg COB 80 mg + GDC 200 mg COB 80 mg + GDC 400 mg COB 100 mg + GDC 200 mg
Hide Arm/Group Description:
One participant was assigned to receive intermittent cobimetinib 80 milligrams (mg) + GDC 0994 200 mg) and did receive study drug. However, the participant diary was not returned, and the site was unable to document study dose administration.
Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Overall Number of Participants Analyzed 0 5 3 2 1 5
Mean (Standard Deviation)
Unit of Measure: mmHg
2.2  (19.6) -4.0  (30.6) -1.5  (0.7) 34.0 -17.2  (20.9)
11.Primary Outcome
Title Mean Change From Baseline in Temperature
Hide Description [Not Specified]
Time Frame Baseline, up to 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants. Data are reported for evaluable participants.
Arm/Group Title Not Assigned COB 20 mg + GDC 200 mg COB 40 mg + GDC 200 mg COB 80 mg + GDC 200 mg COB 80 mg + GDC 400 mg COB 100 mg + GDC 200 mg
Hide Arm/Group Description:
One participant was assigned to receive intermittent cobimetinib 80 milligrams (mg) + GDC 0994 200 mg) and did receive study drug. However, the participant diary was not returned, and the site was unable to document study dose administration.
Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Overall Number of Participants Analyzed 0 5 3 2 1 5
Mean (Standard Deviation)
Unit of Measure: degrees Celsius
-0.04  (0.31) -0.20  (0.87) -0.16  (0.20) -0.20 -0.16  (0.34)
12.Primary Outcome
Title Mean Change From Baseline in Weight
Hide Description [Not Specified]
Time Frame Baseline, up to 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants. Data are reported for evaluable participants.
Arm/Group Title Not Assigned COB 20 mg + GDC 200 mg COB 40 mg + GDC 200 mg COB 80 mg + GDC 200 mg COB 80 mg + GDC 400 mg COB 100 mg + GDC 200 mg
Hide Arm/Group Description:
One participant was assigned to receive intermittent cobimetinib 80 milligrams (mg) + GDC 0994 200 mg) and did receive study drug. However, the participant diary was not returned, and the site was unable to document study dose administration.
Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Overall Number of Participants Analyzed 0 5 3 2 1 5
Mean (Standard Deviation)
Unit of Measure: kg
-4.01  (7.71) 0.33  (1.69) 0.57  (3.34) -2.70 -0.80  (3.43)
13.Secondary Outcome
Title Maximum Serum Concentration (Cmax) for GDC-0994
Hide Description [Not Specified]
Time Frame Up to Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
Data are reported for evaluable participants.
Arm/Group Title COB 80 mg + GDC 300 mg COB 20 mg + GDC 200 mg COB 40 mg + GDC 200 mg COB 80 mg + GDC 200 mg COB 80 mg + GDC 400 mg COB 100 mg + GDC 200 mg
Hide Arm/Group Description:
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 300 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Overall Number of Participants Analyzed 1 5 3 5 4 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: micromoles
Day 1 Number Analyzed 0 participants 5 participants 3 participants 5 participants 4 participants 6 participants
2.51
(54.6%)
2.08
(68.4%)
2.02
(109.0%)
2.42
(33.6%)
2.56
(77.8%)
Steady State Number Analyzed 1 participants 2 participants 1 participants 3 participants 1 participants 2 participants
2.56
1.80
(74.2%)
2.01
(0.0%)
2.26
(23.1%)
2.09
(0.0%)
2.36
(28.2%)
14.Secondary Outcome
Title Median Time to Maximum Serum Concentration (Tmax) for GDC-0994
Hide Description [Not Specified]
Time Frame Up to Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
Data are reported for evaluable participants.
Arm/Group Title COB 80 mg + GDC 300 mg COB 20 mg + GDC 200 mg COB 40 mg + GDC 200 mg COB 80 mg + GDC 200 mg COB 80 mg + GDC 400 mg COB 100 mg + GDC 200 mg
Hide Arm/Group Description:
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 300 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Overall Number of Participants Analyzed 1 5 3 5 4 6
Mean (Full Range)
Unit of Measure: hours
Day 1 Number Analyzed 0 participants 5 participants 3 participants 5 participants 4 participants 6 participants
4.00
(2.00 to 6.00)
6.00
(2.00 to 6.00)
3.00
(2.00 to 24.0)
15.0
(2.0 to 24.0)
2.50
(1.00 to 4.00)
Steady State Number Analyzed 1 participants 2 participants 1 participants 3 participants 1 participants 2 participants
3.00
3.00
(2.00 to 4.00)
24.0
2.00
(2.00 to 3.00)
3.00
2.00
(2.00 to 2.00)
15.Secondary Outcome
Title Maximum Serum Concentration (Cmax) for Cobimetinib
Hide Description [Not Specified]
Time Frame Up to Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
Data are reported for evaluable participants.
Arm/Group Title COB 80 mg + GDC 300 mg COB 20 mg + GDC 200 mg COB 40 mg + GDC 200 mg COB 80 mg + GDC 200 mg COB 80 mg + GDC 400 mg COB 100 mg + GDC 200 mg
Hide Arm/Group Description:
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 300 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Overall Number of Participants Analyzed 1 5 3 5 4 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms per milliliter (ng/mL)
Day 1 Number Analyzed 0 participants 5 participants 3 participants 5 participants 4 participants 6 participants
41.8
(102.0%)
90.2
(60.9%)
392
(31.9%)
155
(52.5%)
384
(53.2%)
Steady State Number Analyzed 1 participants 2 participants 1 participants 3 participants 1 participants 2 participants
73.0
48.5
(121.0%)
204
399
(46.4%)
284
431
(63.3%)
16.Secondary Outcome
Title Median Time to Maximum Serum Concentration (Tmax) for Cobimetinib
Hide Description [Not Specified]
Time Frame Up to Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
Data are reported for evaluable participants.
Arm/Group Title COB 80 mg + GDC 300 mg COB 20 mg + GDC 200 mg COB 40 mg + GDC 200 mg COB 80 mg + GDC 200 mg COB 80 mg + GDC 400 mg COB 100 mg + GDC 200 mg
Hide Arm/Group Description:
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 300 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Overall Number of Participants Analyzed 1 5 3 5 4 6
Median (Full Range)
Unit of Measure: hours
Day 1 Number Analyzed 0 participants 5 participants 3 participants 5 participants 4 participants 6 participants
2.00
(2.00 to 4.00)
2.00
(1.00 to 3.00)
2.00
(1.00 to 3.00)
4.00
(2.00 to 6.00)
2.00
(1.00 to 3.00)
Steady State Number Analyzed 1 participants 2 participants 1 participants 3 participants 1 participants 2 participants
1.00
1.50
(1.00 to 2.00)
24.0
1.00
(0.500 to 2.00)
2.00
2.00
(2.00 to 2.00)
17.Secondary Outcome
Title Total Exposure (AUC From Time 0 to 24 Hour After Dose) for GDC-0994
Hide Description Data are reported for evaluable participants.
Time Frame 0 to 24 hours post-dose (Up to Day 22)
Hide Outcome Measure Data
Hide Analysis Population Description
Data are reported for evaluable participants.
Arm/Group Title COB 80 mg + GDC 300 mg COB 20 mg + GDC 200 mg COB 40 mg + GDC 200 mg COB 80 mg + GDC 200 mg COB 80 mg + GDC 400 mg COB 100 mg + GDC 200 mg
Hide Arm/Group Description:
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 300 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Overall Number of Participants Analyzed 1 5 3 5 4 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hr x microM
Day 1 Number Analyzed 0 participants 5 participants 3 participants 5 participants 4 participants 6 participants
37.0
(45.9%)
32.9
(55.4%)
27.9
(93.8%)
37.8
(37.5%)
37.7
(81.0%)
Steady State Number Analyzed 1 participants 2 participants 1 participants 3 participants 1 participants 1 participants
48.3
23.5
(73.4%)
24.1
33.3
(66.4%)
37.2 34.0
18.Secondary Outcome
Title Total Exposure (AUC From Time 0 to 24 Hour After Dose) for Cobimetinib
Hide Description [Not Specified]
Time Frame 0 to 24 hours post-dose (Up to Day 22)
Hide Outcome Measure Data
Hide Analysis Population Description
Data are reported for evaluable participants.
Arm/Group Title COB 80 mg + GDC 300 mg COB 20 mg + GDC 200 mg COB 40 mg + GDC 200 mg COB 80 mg + GDC 200 mg COB 80 mg + GDC 400 mg COB 100 mg + GDC 200 mg
Hide Arm/Group Description:
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 300 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Overall Number of Participants Analyzed 1 5 3 5 4 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng x hr/mL
Day 1 Number Analyzed 0 participants 5 participants 3 participants 5 participants 4 participants 6 participants
501
(121.0%)
1020
(33.9%)
4420
(25.5%)
2460
(50.9%)
4060
(74.3%)
Steady State Number Analyzed 1 participants 2 participants 1 participants 3 participants 1 participants 1 participants
908
508
(255.0%)
2460
4320
(37.4%)
3410 4070
19.Secondary Outcome
Title Mean Accumulation Ratio
Hide Description [Not Specified]
Time Frame Pre-dose Day 1 Cycle 1, 2, 3, Day 18, 21 Cycle 1; post-dose 0.5, 1, 2, 3, 4, 6 hours Day 1, 18, 21 Cycle 1; Day 2, 15, 19, 22, Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this measure were not collected.
Arm/Group Title Not Assigned COB 20 mg + GDC 200 mg COB 40 mg + GDC 200 mg COB 80 mg + GDC 200 mg COB 80 mg + GDC 400 mg COB 100 mg + GDC 200 mg
Hide Arm/Group Description:
One participant was assigned to receive intermittent cobimetinib 80 milligrams (mg) + GDC 0994 200 mg) and did receive study drug. However, the participant diary was not returned, and the site was unable to document study dose administration.
Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Overall Number of Participants Analyzed 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
20.Secondary Outcome
Title Mean Terminal Half-life (t1/2)
Hide Description [Not Specified]
Time Frame Up to day 22 of study
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this measure were not collected.
Arm/Group Title Not Assigned COB 20 mg + GDC 200 mg COB 40 mg + GDC 200 mg COB 80 mg + GDC 200 mg COB 80 mg + GDC 400 mg COB 100 mg + GDC 200 mg
Hide Arm/Group Description:
One participant was assigned to receive intermittent cobimetinib 80 milligrams (mg) + GDC 0994 200 mg) and did receive study drug. However, the participant diary was not returned, and the site was unable to document study dose administration.
Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Overall Number of Participants Analyzed 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
21.Secondary Outcome
Title Change From Baseline in Fluorodeoxyglucose Positron Emission Tomography (FDG-PET)
Hide Description [Not Specified]
Time Frame Baseline, Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this measure were not collected.
Arm/Group Title Not Assigned COB 20 mg + GDC 200 mg COB 40 mg + GDC 200 mg COB 80 mg + GDC 200 mg COB 80 mg + GDC 400 mg COB 100 mg + GDC 200 mg
Hide Arm/Group Description:
One participant was assigned to receive intermittent cobimetinib 80 milligrams (mg) + GDC 0994 200 mg) and did receive study drug. However, the participant diary was not returned, and the site was unable to document study dose administration.
Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Overall Number of Participants Analyzed 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
22.Secondary Outcome
Title Change From Baseline in Tumor Tissue Biomarkers
Hide Description [Not Specified]
Time Frame Up to 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this measure were not collected.
Arm/Group Title Not Assigned COB 20 mg + GDC 200 mg COB 40 mg + GDC 200 mg COB 80 mg + GDC 200 mg COB 80 mg + GDC 400 mg COB 100 mg + GDC 200 mg
Hide Arm/Group Description:
One participant was assigned to receive intermittent cobimetinib 80 milligrams (mg) + GDC 0994 200 mg) and did receive study drug. However, the participant diary was not returned, and the site was unable to document study dose administration.
Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.
Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Overall Number of Participants Analyzed 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 15 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Not Assigned COB 20 mg + GDC 200 mg COB 40 mg + GDC 200 mg COB 80 mg + GDC 200 mg COB 80 mg + GDC 400 mg COB 100 mg + GDC 200 mg
Hide Arm/Group Description One participant was assigned to receive intermittent cobimetinib 80 milligrams (mg) + GDC 0994 200 mg) and did receive study drug. However, the participant diary was not returned, and the site was unable to document study dose administration. Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off. Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off. Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off. Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off. Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
All-Cause Mortality
Not Assigned COB 20 mg + GDC 200 mg COB 40 mg + GDC 200 mg COB 80 mg + GDC 200 mg COB 80 mg + GDC 400 mg COB 100 mg + GDC 200 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Not Assigned COB 20 mg + GDC 200 mg COB 40 mg + GDC 200 mg COB 80 mg + GDC 200 mg COB 80 mg + GDC 400 mg COB 100 mg + GDC 200 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/1 (100.00%)      2/5 (40.00%)      2/3 (66.67%)      3/5 (60.00%)      2/4 (50.00%)      4/6 (66.67%)    
Blood and lymphatic system disorders             
ANAEMIA  1  0/1 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
Cardiac disorders             
MYOCARDIAL INFARCTION  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0
Gastrointestinal disorders             
DIARRHOEA  1  0/1 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1
ABDOMINAL PAIN  1  1/1 (100.00%)  1 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
COLITIS  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0
CONSTIPATION  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1
DYSPHAGIA  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0
GASTRIC ULCER  1  0/1 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
GASTROINTESTINAL HAEMORRHAGE  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1
NAUSEA  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0
General disorders             
DISEASE PROGRESSION  1  0/1 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
GAIT DISTURBANCE  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0
OEDEMA PERIPHERAL  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0
PYREXIA  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1
Infections and infestations             
CHOLANGITIS INFECTIVE  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1
CLOSTRIDIUM DIFFICILE COLITIS  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1
KLEBSIELLA BACTERAEMIA  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0
PNEUMONIA  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1
PNEUMONIA VIRAL  1  1/1 (100.00%)  1 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
Metabolism and nutrition disorders             
DEHYDRATION  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
DYSPNOEA  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0
HYPOXIA  1  1/1 (100.00%)  1 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
PULMONARY EMBOLISM  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, 19.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Not Assigned COB 20 mg + GDC 200 mg COB 40 mg + GDC 200 mg COB 80 mg + GDC 200 mg COB 80 mg + GDC 400 mg COB 100 mg + GDC 200 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/1 (100.00%)      5/5 (100.00%)      3/3 (100.00%)      5/5 (100.00%)      4/4 (100.00%)      6/6 (100.00%)    
Blood and lymphatic system disorders             
ANAEMIA  1  0/1 (0.00%)  0 1/5 (20.00%)  1 1/3 (33.33%)  1 1/5 (20.00%)  1 2/4 (50.00%)  3 1/6 (16.67%)  1
THROMBOCYTOPENIA  1  0/1 (0.00%)  0 1/5 (20.00%)  1 1/3 (33.33%)  2 0/5 (0.00%)  0 1/4 (25.00%)  1 2/6 (33.33%)  3
Cardiac disorders             
ACUTE MYOCARDIAL INFARCTION  1  0/1 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
LEFT VENTRICULAR DYSFUNCTION  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0
SINUS BRADYCARDIA  1  0/1 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
SINUS TACHYCARDIA  1  0/1 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
TACHYCARDIA  1  0/1 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
Ear and labyrinth disorders             
DYSACUSIS  1  0/1 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
VERTIGO  1  0/1 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
Endocrine disorders             
ADRENAL INSUFFICIENCY  1  0/1 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
Eye disorders             
DETACHMENT OF RETINAL PIGMENT EPITHELIUM  1  0/1 (0.00%)  0 2/5 (40.00%)  2 1/3 (33.33%)  1 1/5 (20.00%)  1 0/4 (0.00%)  0 1/6 (16.67%)  1
EYELID OEDEMA  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0
PERIORBITAL OEDEMA  1  0/1 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 1/4 (25.00%)  1 1/6 (16.67%)  1
PHOTOPHOBIA  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0
VISION BLURRED  1  0/1 (0.00%)  0 2/5 (40.00%)  2 1/3 (33.33%)  1 0/5 (0.00%)  0 3/4 (75.00%)  3 1/6 (16.67%)  1
VISUAL IMPAIRMENT  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1
VITREOUS FLOATERS  1  0/1 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
Gastrointestinal disorders             
ABDOMINAL DISTENSION  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/4 (25.00%)  1 1/6 (16.67%)  1
ABDOMINAL PAIN  1  0/1 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1
ABDOMINAL PAIN LOWER  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0
ABDOMINAL PAIN UPPER  1  0/1 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0 1/6 (16.67%)  3
ASCITES  1  0/1 (0.00%)  0 1/5 (20.00%)  1 1/3 (33.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1
COLITIS  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1
CONSTIPATION  1  0/1 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
DIARRHOEA  1  1/1 (100.00%)  1 4/5 (80.00%)  5 2/3 (66.67%)  2 5/5 (100.00%)  10 4/4 (100.00%)  4 4/6 (66.67%)  8
DRY MOUTH  1  0/1 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
DYSPEPSIA  1  0/1 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 1/4 (25.00%)  1 1/6 (16.67%)  1
DYSPHAGIA  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0
FLATULENCE  1  0/1 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
GASTROINTESTINAL HAEMORRHAGE  1  0/1 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
GASTROOESOPHAGEAL REFLUX DISEASE  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0
HAEMATOCHEZIA  1  0/1 (0.00%)  0 1/5 (20.00%)  1 2/3 (66.67%)  2 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
NAUSEA  1  1/1 (100.00%)  2 5/5 (100.00%)  5 2/3 (66.67%)  2 4/5 (80.00%)  5 3/4 (75.00%)  3 2/6 (33.33%)  3
SALIVARY GLAND ENLARGEMENT  1  0/1 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
VOMITING  1  1/1 (100.00%)  1 3/5 (60.00%)  4 1/3 (33.33%)  1 5/5 (100.00%)  6 3/4 (75.00%)  4 3/6 (50.00%)  4
General disorders             
ASTHENIA  1  0/1 (0.00%)  0 3/5 (60.00%)  3 2/3 (66.67%)  2 0/5 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0
CHILLS  1  0/1 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 1/5 (20.00%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0
FACE OEDEMA  1  0/1 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 3/5 (60.00%)  3 1/4 (25.00%)  1 1/6 (16.67%)  1
FATIGUE  1  0/1 (0.00%)  0 4/5 (80.00%)  4 1/3 (33.33%)  1 2/5 (40.00%)  4 2/4 (50.00%)  5 3/6 (50.00%)  4
GENERALISED OEDEMA  1  0/1 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0
LOCALISED OEDEMA  1  0/1 (0.00%)  0 0/5 (0.00%)  0 2/3 (66.67%)  2 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
NON-CARDIAC CHEST PAIN  1  0/1 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0
OEDEMA PERIPHERAL  1  0/1 (0.00%)  0 2/5 (40.00%)  3 1/3 (33.33%)  3 2/5 (40.00%)  2 1/4 (25.00%)  1 0/6 (0.00%)  0
PERIPHERAL SWELLING  1  0/1 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
PYREXIA  1  0/1 (0.00%)  0 1/5 (20.00%)  1 1/3 (33.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
Infections and infestations             
ATYPICAL PNEUMONIA  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0
BRONCHITIS  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1
CANDIDA INFECTION  1  0/1 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
PNEUMONIA  1  0/1 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1
SEPSIS  1  0/1 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
UPPER RESPIRATORY TRACT INFECTION  1  0/1 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
VULVOVAGINAL MYCOTIC INFECTION  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1
Injury, poisoning and procedural complications             
CONTUSION  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0
LACERATION  1  0/1 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
Investigations             
ALANINE AMINOTRANSFERASE INCREASED  1  0/1 (0.00%)  0 1/5 (20.00%)  2 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 2/6 (33.33%)  3
ASPARTATE AMINOTRANSFERASE INCREASED  1  0/1 (0.00%)  0 2/5 (40.00%)  3 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 2/6 (33.33%)  9
BLOOD ALBUMIN DECREASED  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1
BLOOD ALKALINE PHOSPHATASE INCREASED  1  0/1 (0.00%)  0 2/5 (40.00%)  2 0/3 (0.00%)  0 0/5 (0.00%)  0 1/4 (25.00%)  2 2/6 (33.33%)  4
BLOOD BILIRUBIN INCREASED  1  0/1 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0
BLOOD LACTATE DEHYDROGENASE INCREASED  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1
BLOOD LACTIC ACID INCREASED  1  0/1 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
BLOOD UREA INCREASED  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1
EJECTION FRACTION DECREASED  1  0/1 (0.00%)  0 2/5 (40.00%)  2 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
GAMMA-GLUTAMYLTRANSFERASE INCREASED  1  0/1 (0.00%)  0 1/5 (20.00%)  2 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  4
PLATELET COUNT DECREASED  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/4 (25.00%)  4 0/6 (0.00%)  0
PROTEIN TOTAL DECREASED  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1
TROPONIN INCREASED  1  0/1 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
WEIGHT DECREASED  1  0/1 (0.00%)  0 1/5 (20.00%)  1 1/3 (33.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
WHITE BLOOD CELL COUNT INCREASED  1  0/1 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1
Metabolism and nutrition disorders             
DECREASED APPETITE  1  0/1 (0.00%)  0 1/5 (20.00%)  1 2/3 (66.67%)  2 3/5 (60.00%)  3 2/4 (50.00%)  2 2/6 (33.33%)  2
DEHYDRATION  1  0/1 (0.00%)  0 3/5 (60.00%)  4 2/3 (66.67%)  3 3/5 (60.00%)  3 2/4 (50.00%)  2 1/6 (16.67%)  1
HYPERKALAEMIA  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1
HYPOALBUMINAEMIA  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  2
HYPOCALCAEMIA  1  0/1 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  2 0/5 (0.00%)  0 1/4 (25.00%)  1 1/6 (16.67%)  2
HYPOGLYCAEMIA  1  0/1 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
HYPOKALAEMIA  1  0/1 (0.00%)  0 1/5 (20.00%)  1 1/3 (33.33%)  2 1/5 (20.00%)  2 1/4 (25.00%)  1 1/6 (16.67%)  1
HYPOMAGNESAEMIA  1  0/1 (0.00%)  0 1/5 (20.00%)  1 1/3 (33.33%)  2 1/5 (20.00%)  2 0/4 (0.00%)  0 1/6 (16.67%)  1
HYPONATRAEMIA  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  3
HYPOPHOSPHATAEMIA  1  0/1 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
HYPOVOLAEMIA  1  0/1 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 1/5 (20.00%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0
MALNUTRITION  1  0/1 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
Musculoskeletal and connective tissue disorders             
ARTHRALGIA  1  0/1 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0
BACK PAIN  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0 1/6 (16.67%)  1
MUSCLE SPASMS  1  0/1 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
MUSCULAR WEAKNESS  1  0/1 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0
MYALGIA  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 1/4 (25.00%)  1 0/6 (0.00%)  0
PAIN IN EXTREMITY  1  0/1 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
Nervous system disorders             
ATAXIA  1  0/1 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
BURNING SENSATION  1  0/1 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
DIZZINESS  1  0/1 (0.00%)  0 0/5 (0.00%)  0 2/3 (66.67%)  2 2/5 (40.00%)  2 0/4 (0.00%)  0 0/6 (0.00%)  0
HEADACHE  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0
HYPOAESTHESIA  1  0/1 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
LETHARGY  1  0/1 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
PRESYNCOPE  1  0/1 (0.00%)  0 1/5 (20.00%)  1 1/3 (33.33%)  1 1/5 (20.00%)  1 0/4 (0.00%)  0 1/6 (16.67%)  1
SOMNOLENCE  1  0/1 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
SYNCOPE  1  0/1 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
VISUAL FIELD DEFECT  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1
Psychiatric disorders             
CONFUSIONAL STATE  1  0/1 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
DELIRIUM  1  0/1 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
INSOMNIA  1  0/1 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
Renal and urinary disorders             
ACUTE KIDNEY INJURY  1  0/1 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
DYSURIA  1  0/1 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
HAEMATURIA  1  0/1 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
URINARY RETENTION  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
ALVEOLAR LUNG DISEASE  1  0/1 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
COUGH  1  0/1 (0.00%)  0 2/5 (40.00%)  2 1/3 (33.33%)  1 0/5 (0.00%)  0 1/4 (25.00%)  1 1/6 (16.67%)  1
DYSPHONIA  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0
DYSPNOEA  1  1/1 (100.00%)  1 1/5 (20.00%)  1 0/3 (0.00%)  0 1/5 (20.00%)  1 1/4 (25.00%)  1 1/6 (16.67%)  1
EPISTAXIS  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0 1/6 (16.67%)  1
PLEURAL EFFUSION  1  0/1 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0
PNEUMONITIS  1  0/1 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
PULMONARY EMBOLISM  1  0/1 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
PULMONARY HYPERTENSION  1  0/1 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
PULMONARY OEDEMA  1  0/1 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
RHINORRHOEA  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0
SINUS CONGESTION  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0
TONSILLAR HYPERTROPHY  1  0/1 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
Skin and subcutaneous tissue disorders             
ALOPECIA  1  0/1 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
DERMATITIS ACNEIFORM  1  1/1 (100.00%)  2 2/5 (40.00%)  3 2/3 (66.67%)  3 1/5 (20.00%)  1 4/4 (100.00%)  6 1/6 (16.67%)  1
DRY SKIN  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 2/5 (40.00%)  3 1/4 (25.00%)  1 0/6 (0.00%)  0
HYPERHIDROSIS  1  0/1 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
NIGHT SWEATS  1  0/1 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
PAIN OF SKIN  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0
RASH  1  1/1 (100.00%)  2 1/5 (20.00%)  1 1/3 (33.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1
RASH MACULAR  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1
RASH MACULO-PAPULAR  1  0/1 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 2/5 (40.00%)  2 0/4 (0.00%)  0 0/6 (0.00%)  0
RASH PRURITIC  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0
SWELLING FACE  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0
Vascular disorders             
DEEP VEIN THROMBOSIS  1  0/1 (0.00%)  0 1/5 (20.00%)  1 1/3 (33.33%)  1 1/5 (20.00%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0
HYPOTENSION  1  0/1 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 1/5 (20.00%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0
THROMBOSIS  1  0/1 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, 19.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-LaRoche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02457793    
Other Study ID Numbers: GO29653
2015-000092-27 ( EudraCT Number )
First Submitted: May 27, 2015
First Posted: May 29, 2015
Results First Submitted: November 28, 2017
Results First Posted: August 24, 2018
Last Update Posted: November 20, 2018