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TIGER-3: Open Label, Multicenter Study of Rociletinib (CO-1686) Mono Therapy Versus Single-agent Cytotoxic Chemotherapy in Patients With Mutant EGFR NSCLC Who Have Failed at Least One Previous EGFR-Directed TKI and Platinum-doublet Chemotherapy

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ClinicalTrials.gov Identifier: NCT02322281
Recruitment Status : Terminated (Sponsor discontinued development of CO-1686 for NSCLC)
First Posted : December 23, 2014
Results First Posted : July 23, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Clovis Oncology, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-small Cell Lung Cancer
Interventions Drug: Rociletinib
Drug: Pemetrexed or gemcitabine or paclitaxel or docetaxel
Enrollment 149
Recruitment Details 149 subjects recruited from 83 sites in 10 countries and randomized (1:1) to treatment with rociletinib or single-agent cytotoxic chemotherapy (investigator's choice of pemetrexed, gemcitabine, docetaxel, or paclitaxel). Crossover to rociletinib treatment permitted for comparator chemotherapy treated subjects but only after eligibility confirmed.
Pre-assignment Details  
Arm/Group Title Rociletinib 500 mg BID Rociletinib 625 mg BID Chemotherapy
Hide Arm/Group Description Starting dose of 500mg. Taken orally twice daily (continuous 21 day treatment cycle). Treatment duration until radiographically confirmed disease progression. Starting dose of 625mg. Taken orally twice daily (continuous 21 day treatment cycle). Treatment duration until radiographically confirmed disease progression.

Pemetrexed - 500 mg/m2 pemetrexed given intravenously on Day 1 of each 21-day cycle.

Gemcitabine - 1250 mg/m2 gemcitabine given intravenously on Day 1 and 8 of each 21-day cycle.

Paclitaxel - 80 mg/m2 paclitaxel given intravenously on a weekly basis as part of a continuous 21-day cycle; i.e. dosing will be on Days 1, 8, and 15 of each 21-day cycle.

Docetaxel - 75 mg/m2 docetaxel (60 mg/m2 for patients residing in East-Asian territories) given intravenously on Day 1 of each 21-day cycle.

or 35 mg/m2 docetaxel given intravenously on a weekly basis as part of a continuous 21-day cycle; i.e. dosing will be on Days 1, 8, and 15 of each 21-day cycle.

Treatment duration until radiographically confirmed disease progression.

Period Title: Overall Study
Started 53 22 74
Crossed Over to Rociletinib 500 mg BID 0 0 36
Crossed Over to Rociletinib 625 mg BID 0 0 3
Completed 0 [1] 0 [1] 0 [1]
Not Completed 53 22 74
Reason Not Completed
Progressive Disease             42             14             49
Adverse Event             3             4             6
Death             3             3             3
Withdrawal by Subject             1             1             6
Physician Decision             2             0             5
Study Terminated by Sponsor             2             0             0
Missing             0             0             1
Miscellaneous             0             0             4
[1]
Patients who are off study for any reason.
Arm/Group Title Rociletinib 500 mg BID Rociletinib 625 mg BID Chemotherapy Total
Hide Arm/Group Description Starting dose of 500mg. Taken orally twice daily (continuous 21 day treatment cycle). Treatment duration until radiographically confirmed disease progression. Starting dose of 625mg. Taken orally twice daily (continuous 21 day treatment cycle). Treatment duration until radiographically confirmed disease progression.

Pemetrexed - 500 mg/m2 pemetrexed given intravenously on Day 1 of each 21-day cycle.

Gemcitabine - 1250 mg/m2 gemcitabine given intravenously on Day 1 and 8 of each 21-day cycle.

Paclitaxel - 80 mg/m2 paclitaxel given intravenously on a weekly basis as part of a continuous 21-day cycle; i.e. dosing will be on Days 1, 8, and 15 of each 21-day cycle.

Docetaxel - 75 mg/m2 docetaxel (60 mg/m2 for patients residing in East-Asian territories) given intravenously on Day 1 of each 21-day cycle.

or 35 mg/m2 docetaxel given intravenously on a weekly basis as part of a continuous 21-day cycle; i.e. dosing will be on Days 1, 8, and 15 of each 21-day cycle.

Treatment duration until radiographically confirmed disease progression.

Total of all reporting groups
Overall Number of Baseline Participants 53 22 74 149
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants 22 participants 74 participants 149 participants
61.6  (11.66) 63.4  (12.30) 61.4  (9.84) 61.8  (10.84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 22 participants 74 participants 149 participants
Female
35
  66.0%
13
  59.1%
39
  52.7%
87
  58.4%
Male
18
  34.0%
9
  40.9%
35
  47.3%
62
  41.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 22 participants 74 participants 149 participants
Hispanic or Latino
4
   7.5%
0
   0.0%
3
   4.1%
7
   4.7%
Not Hispanic or Latino
46
  86.8%
22
 100.0%
68
  91.9%
136
  91.3%
Unknown or Not Reported
3
   5.7%
0
   0.0%
3
   4.1%
6
   4.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 22 participants 74 participants 149 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
23
  43.4%
6
  27.3%
30
  40.5%
59
  39.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
1
   1.4%
1
   0.7%
Black or African American
2
   3.8%
0
   0.0%
3
   4.1%
5
   3.4%
White
24
  45.3%
15
  68.2%
38
  51.4%
77
  51.7%
More than one race
0
   0.0%
1
   4.5%
1
   1.4%
2
   1.3%
Unknown or Not Reported
4
   7.5%
0
   0.0%
1
   1.4%
5
   3.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
White Number Analyzed 53 participants 22 participants 74 participants 149 participants
24
  45.3%
15
  68.2%
38
  51.4%
77
  51.7%
Asian Number Analyzed 53 participants 22 participants 74 participants 149 participants
23
  43.4%
6
  27.3%
30
  40.5%
59
  39.6%
Non-White, Non-Asian Number Analyzed 53 participants 22 participants 74 participants 149 participants
6
  11.3%
1
   4.5%
6
   8.1%
13
   8.7%
Number of Previous Therapies  
Median (Full Range)
Unit of measure:  Therapies
Number Analyzed 53 participants 22 participants 74 participants 149 participants
3.0
(1.0 to 8.0)
3.0
(2.0 to 6.0)
3.0
(0.0 to 13.0)
3.0
(0.0 to 13.0)
Time Since Diagnosis of NSCLC   [1] 
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 53 participants 22 participants 73 participants 148 participants
42.6  (35.54) 37.5  (16.92) 39.0  (25.10) 40.1  (28.29)
[1]
Measure Analysis Population Description: Information missing for one patient in the Chemotherapy treatment group.
History of CNS Metastases  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 22 participants 74 participants 149 participants
23
  43.4%
9
  40.9%
31
  41.9%
63
  42.3%
1.Primary Outcome
Title Progression Free Survival (PFS) According to RECIST Version 1.1 as Determined by Investigator Review (invPFS)
Hide Description PFS was calculated as 1+ the number of days from the date of randomization to documented radiographic progression as determined by the investigator, or death due to any cause, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of one or more new lesions is also considered progression.
Time Frame Cycle 1 Day 1 to End of Treatment, up to approximately 35 months. This Time Frame includes the cross-over period, however, participants who crossed over to rociletinib were not analyzed for PFS.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat: All patients randomized. 1 patient in the Chemotherapy treatment group was not included in the analysis, due to discontinuation of study shortly after randomization and prior to first dose of study drug.
Arm/Group Title Rociletinib 500 mg BID Rociletinib 625 mg BID Chemotherapy
Hide Arm/Group Description:
Starting dose of 500mg. Taken orally twice daily (continuous 21 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
Starting dose of 625mg. Taken orally twice daily (continuous 21 day treatment cycle). Treatment duration until radiographically confirmed disease progression.

Pemetrexed - 500 mg/m2 pemetrexed given intravenously on Day 1 of each 21-day cycle.

Gemcitabine - 1250 mg/m2 gemcitabine given intravenously on Day 1 and 8 of each 21-day cycle.

Paclitaxel - 80 mg/m2 paclitaxel given intravenously on a weekly basis as part of a continuous 21-day cycle; i.e. dosing will be on Days 1, 8, and 15 of each 21-day cycle.

Docetaxel - 75 mg/m2 docetaxel (60 mg/m2 for patients residing in East-Asian territories) given intravenously on Day 1 of each 21-day cycle.

or 35 mg/m2 docetaxel given intravenously on a weekly basis as part of a continuous 21-day cycle; i.e. dosing will be on Days 1, 8, and 15 of each 21-day cycle.

Treatment duration until radiographically confirmed disease progression.

Overall Number of Participants Analyzed 53 22 73
Median (95% Confidence Interval)
Unit of Measure: Days
125.0
(79.0 to 165.0)
166.0
(56.0 to 246.0)
77.0
(42.0 to 88.0)
2.Secondary Outcome
Title Percentage of Participants With Confirmed Response
Hide Description Percentage of patients with a best overall confirmed response of partial response (PR) or complete response (CR) recorded from the start of the treatment until disease progression or recurrence. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, defined by and assessed as: Complete Response (CR), is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR),at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. Overall Response (OR),is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment was dependent on the achievement of both measurement and confirmation criteria.
Time Frame Cycle 1 Day 1 to End of Treatment, up to approximately 35 months. This Time Frame includes the cross-over period, however, participants who crossed over to rociletinib were not analyzed for best overall confirmed response.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat: All patients randomized. 1 patient in the Chemotherapy treatment group was not included in the analysis, due to discontinuation of study shortly after randomization and prior to first dose of study drug.
Arm/Group Title Rociletinib 500 mg BID Rociletinib 625 mg BID Chemotherapy
Hide Arm/Group Description:
Starting dose of 500mg. Taken orally twice daily (continuous 21 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
Starting dose of 625mg. Taken orally twice daily (continuous 21 day treatment cycle). Treatment duration until radiographically confirmed disease progression.

Pemetrexed - 500 mg/m2 pemetrexed given intravenously on Day 1 of each 21-day cycle.

Gemcitabine - 1250 mg/m2 gemcitabine given intravenously on Day 1 and 8 of each 21-day cycle.

Paclitaxel - 80 mg/m2 paclitaxel given intravenously on a weekly basis as part of a continuous 21-day cycle; i.e. dosing will be on Days 1, 8, and 15 of each 21-day cycle.

Docetaxel - 75 mg/m2 docetaxel (60 mg/m2 for patients residing in East-Asian territories) given intravenously on Day 1 of each 21-day cycle.

or 35 mg/m2 docetaxel given intravenously on a weekly basis as part of a continuous 21-day cycle; i.e. dosing will be on Days 1, 8, and 15 of each 21-day cycle.

Treatment duration until radiographically confirmed disease progression.

Overall Number of Participants Analyzed 53 22 73
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
17.0
(8.1 to 29.8)
18.2
(5.2 to 40.3)
8.2
(3.1 to 17.0)
3.Secondary Outcome
Title Duration of Response (DOR) According to RECIST Version 1.1 as Determined by Investigator Assessment
Hide Description DOR in patients with confirmed response per investigator. The DOR for complete response (CR) and partial response (PR) was measured from date that any of these best responses is first recorded until first date that progressive disease (PD) is objectively documented. For patients who continue treatment post-progression, the first date of progression was used for the analysis. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, defined by and assessed as: CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm. PR is at least a 30% decrease in sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. Overall Response is the best response from start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started).
Time Frame Cycle 1 Day 1 to End of Treatment, up to approximately 35 months
Hide Outcome Measure Data
Hide Analysis Population Description
The DOR was measured only in those patients with a confirmed Complete Response (CR) or Partial Response (PR). The overall number of participants analyzed in the "Chemotherapy" arm includes only participants treated with chemotherapy and not patients who crossed over into the rociletinib treatment groups.
Arm/Group Title Rociletinib 500 mg BID Rociletinib 625 mg BID Chemotherapy
Hide Arm/Group Description:
Starting dose of 500mg. Taken orally twice daily (continuous 21 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
Starting dose of 625mg. Taken orally twice daily (continuous 21 day treatment cycle). Treatment duration until radiographically confirmed disease progression.

Pemetrexed - 500 mg/m2 pemetrexed given intravenously on Day 1 of each 21-day cycle.

Gemcitabine - 1250 mg/m2 gemcitabine given intravenously on Day 1 and 8 of each 21-day cycle.

Paclitaxel - 80 mg/m2 paclitaxel given intravenously on a weekly basis as part of a continuous 21-day cycle; i.e. dosing will be on Days 1, 8, and 15 of each 21-day cycle.

Docetaxel - 75 mg/m2 docetaxel (60 mg/m2 for patients residing in East-Asian territories) given intravenously on Day 1 of each 21-day cycle.

or 35 mg/m2 docetaxel given intravenously on a weekly basis as part of a continuous 21-day cycle; i.e. dosing will be on Days 1, 8, and 15 of each 21-day cycle.

Treatment duration until radiographically confirmed disease progression.

Overall Number of Participants Analyzed 9 4 6
Median (95% Confidence Interval)
Unit of Measure: Days
335.0
(77.0 to 418.0)
275.0
(167.0 to 375.0)
206.0 [1] 
(136.0 to NA)
[1]
Upper confidence limit is not available because it could be calculated.
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was calculated as 1+ the number of days from randomization to death due to any cause. Patients without a documented date of death were censored on the date the patient was last known to be alive.
Time Frame Cycle 1 Day 1 to date of death, assessed up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat: All patients randomized.1 patient in the Roci 500 and 2 patients in the Chemo treatment group were not included in the analysis because their OS data was not collected. 1 additional patient in the Chemo group was not included due to discontinuation from study shortly after randomization and prior to first dose of study drug.
Arm/Group Title Rociletinib 500 mg BID Rociletinib 625 mg BID Chemotherapy
Hide Arm/Group Description:
Starting dose of 500mg. Taken orally twice daily (continuous 21 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
Starting dose of 625mg. Taken orally twice daily (continuous 21 day treatment cycle). Treatment duration until radiographically confirmed disease progression.

Pemetrexed - 500 mg/m2 pemetrexed given intravenously on Day 1 of each 21-day cycle.

Gemcitabine - 1250 mg/m2 gemcitabine given intravenously on Day 1 and 8 of each 21-day cycle.

Paclitaxel - 80 mg/m2 paclitaxel given intravenously on a weekly basis as part of a continuous 21-day cycle; i.e. dosing will be on Days 1, 8, and 15 of each 21-day cycle.

Docetaxel - 75 mg/m2 docetaxel (60 mg/m2 for patients residing in East-Asian territories) given intravenously on Day 1 of each 21-day cycle.

or 35 mg/m2 docetaxel given intravenously on a weekly basis as part of a continuous 21-day cycle; i.e. dosing will be on Days 1, 8, and 15 of each 21-day cycle.

Treatment duration until radiographically confirmed disease progression.

Overall Number of Participants Analyzed 52 22 71
Median (95% Confidence Interval)
Unit of Measure: Days
665 [1] 
(232 to NA)
541 [1] 
(173 to NA)
348
(231 to 522)
[1]
The upper Confidence Limit is not available because it could not be calculated.
5.Secondary Outcome
Title Plasma PK for Patients Treated With Rociletinib Based on Sparse Sampling
Hide Description Blood samples were drawn for PK analysis at 21 ± 3 day intervals for the first 6 months (Day 1 of Cycles 2 to 7 inclusive). The sample could be taken predose or postdose. Plasma concentrations are presented for Rociletinib and 3 metabolites (M460, M502, M544).
Time Frame Cycles 2 Day 1 to Cycle 7 Day 1, or approximately 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
A small subset of patients treated with rociletinib (ie, patients randomized to receive rociletinib or who crossed over to receive rociletinib following treatment with single agent cytotoxic chemotherapy). Note: 2 patients in the 625mg treatment group had M502 values at upper limit of quantification (ULOQ) which were set as missing values.
Arm/Group Title Rociletinib 500 mg BID Rociletinib 625 mg BID
Hide Arm/Group Description:
Starting dose of 500mg. Taken orally twice daily (continuous 21 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
Starting dose of 625mg. Taken orally twice daily (continuous 21 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
Overall Number of Participants Analyzed 1 10
Overall Number of Units Analyzed
Type of Units Analyzed: Plasma samples
1 33
Median (Full Range)
Unit of Measure: Plasma concentration (ng/mL)
Rociletinib Number Analyzed 1 Plasma samples 33 Plasma samples
80.4
(80.4 to 80.4)
207.0
(10.0 to 988.0)
M460 Number Analyzed 1 Plasma samples 33 Plasma samples
20.0
(20.0 to 20.0)
555.0
(144.0 to 1200.0)
M502 Number Analyzed 1 Plasma samples 31 Plasma samples
573.0
(573.0 to 573.0)
3260.0
(98.4 to 4880.0)
M544 Number Analyzed 1 Plasma samples 33 Plasma samples
765.0
(765.0 to 765.0)
525.0
(20.0 to 3640.0)
Time Frame Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, an average of 6 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
Adverse Event Reporting Description If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects who crossed over to Rociletinib from Chemotherapy are included. 1 patient in the Chemotherapy treatment group was not included in the analysis, due to discontinuation of study shortly after randomization and prior to first dose of study drug.
 
Arm/Group Title Rociletinib 500 mg BID Rociletinib 625 mg BID Chemotherapy Crossover From Chemotherapy to Rociletinib 500 mg BID Crossover From Chemotherapy to Rociletinib 625 mg BID
Hide Arm/Group Description Starting dose of 500 mg. Taken orally twice daily (continuous 21 day treatment cycle). Treatment duration until radiographically confirmed disease progression. Starting dose of 625 mg. Taken orally twice daily (continuous 21 day treatment cycle). Treatment duration until radiographically confirmed disease progression.

Pemetrexed - 500 mg/m2 pemetrexed given intravenously on Day 1 of each 21-day cycle.

Gemcitabine - 1250 mg/m2 gemcitabine given intravenously on Day 1 and 8 of each 21-day cycle.

Paclitaxel - 80 mg/m2 paclitaxel given intravenously on a weekly basis as part of a continuous 21-day cycle; i.e. dosing will be on Days 1, 8, and 15 of each 21-day cycle.

Docetaxel - 75 mg/m2 docetaxel (60 mg/m2 for patients residing in East-Asian territories) given intravenously on Day 1 of each 21-day cycle.

or 35 mg/m2 docetaxel given intravenously on a weekly basis as part of a continuous 21-day cycle; i.e. dosing will be on Days 1, 8, and 15 of each 21-day cycle.

Treatment duration until radiographically confirmed disease progression.

Patients initially randomized to comparator chemotherapy had the option to cross over to rociletinib following disease progression per RECIST Version 1.1. Rociletinib starting dose of 500 mg taken orally twice daily (continuous 21 day treatment cycle). Treatment duration until radiographically confirmed disease progression. Patients initially randomized to comparator chemotherapy had the option to cross over to rociletinib following disease progression per RECIST Version 1.1. Rociletinib starting dose of 625 mg taken orally twice daily (continuous 21 day treatment cycle). Treatment duration until radiographically confirmed disease progression
All-Cause Mortality
Rociletinib 500 mg BID Rociletinib 625 mg BID Chemotherapy Crossover From Chemotherapy to Rociletinib 500 mg BID Crossover From Chemotherapy to Rociletinib 625 mg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/53 (18.87%)   3/22 (13.64%)   3/73 (4.11%)   6/36 (16.67%)   0/3 (0.00%) 
Hide Serious Adverse Events
Rociletinib 500 mg BID Rociletinib 625 mg BID Chemotherapy Crossover From Chemotherapy to Rociletinib 500 mg BID Crossover From Chemotherapy to Rociletinib 625 mg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   23/53 (43.40%)   7/22 (31.82%)   23/73 (31.51%)   18/36 (50.00%)   1/3 (33.33%) 
Blood and lymphatic system disorders           
Febrile neutropenia  1  0/53 (0.00%)  0/22 (0.00%)  2/73 (2.74%)  0/36 (0.00%)  0/3 (0.00%) 
Neutropenia  1  0/53 (0.00%)  0/22 (0.00%)  1/73 (1.37%)  0/36 (0.00%)  0/3 (0.00%) 
Anaemia  1  0/53 (0.00%)  0/22 (0.00%)  0/73 (0.00%)  1/36 (2.78%)  0/3 (0.00%) 
Cardiac disorders           
Angina pectoris  1  0/53 (0.00%)  0/22 (0.00%)  1/73 (1.37%)  0/36 (0.00%)  0/3 (0.00%) 
Atrial fibrillation  1  0/53 (0.00%)  0/22 (0.00%)  1/73 (1.37%)  0/36 (0.00%)  0/3 (0.00%) 
Bradycardia  1  1/53 (1.89%)  0/22 (0.00%)  0/73 (0.00%)  0/36 (0.00%)  0/3 (0.00%) 
Cardio-pulmonary arrest  1  1/53 (1.89%)  0/22 (0.00%)  0/73 (0.00%)  0/36 (0.00%)  0/3 (0.00%) 
Myocardial infarction  1  0/53 (0.00%)  0/22 (0.00%)  1/73 (1.37%)  0/36 (0.00%)  0/3 (0.00%) 
Nodal arrhythmia  1  0/53 (0.00%)  0/22 (0.00%)  0/73 (0.00%)  1/36 (2.78%)  0/3 (0.00%) 
Ventricular fibrillation  1  0/53 (0.00%)  0/22 (0.00%)  0/73 (0.00%)  1/36 (2.78%)  0/3 (0.00%) 
Eye disorders           
Cataract  1  0/53 (0.00%)  1/22 (4.55%)  0/73 (0.00%)  1/36 (2.78%)  0/3 (0.00%) 
Gastrointestinal disorders           
Abdominal pain  1  1/53 (1.89%)  0/22 (0.00%)  0/73 (0.00%)  0/36 (0.00%)  0/3 (0.00%) 
Colitis  1  0/53 (0.00%)  0/22 (0.00%)  1/73 (1.37%)  0/36 (0.00%)  0/3 (0.00%) 
Diarrhoea  1  1/53 (1.89%)  0/22 (0.00%)  0/73 (0.00%)  0/36 (0.00%)  0/3 (0.00%) 
Dysphagia  1  0/53 (0.00%)  0/22 (0.00%)  2/73 (2.74%)  0/36 (0.00%)  0/3 (0.00%) 
Nausea  1  0/53 (0.00%)  1/22 (4.55%)  1/73 (1.37%)  0/36 (0.00%)  0/3 (0.00%) 
Small intestinal obstruction  1  0/53 (0.00%)  0/22 (0.00%)  1/73 (1.37%)  0/36 (0.00%)  0/3 (0.00%) 
Upper gastrointestinal haemorrhage  1  1/53 (1.89%)  0/22 (0.00%)  0/73 (0.00%)  0/36 (0.00%)  0/3 (0.00%) 
Vomiting  1  0/53 (0.00%)  1/22 (4.55%)  0/73 (0.00%)  0/36 (0.00%)  0/3 (0.00%) 
Anal fistula  1  0/53 (0.00%)  0/22 (0.00%)  0/73 (0.00%)  1/36 (2.78%)  0/3 (0.00%) 
Pancreatitis  1  0/53 (0.00%)  0/22 (0.00%)  0/73 (0.00%)  3/36 (8.33%)  0/3 (0.00%) 
Pancreatitis acute  1  0/53 (0.00%)  0/22 (0.00%)  0/73 (0.00%)  1/36 (2.78%)  0/3 (0.00%) 
General disorders           
Asthenia  1  0/53 (0.00%)  0/22 (0.00%)  1/73 (1.37%)  1/36 (2.78%)  0/3 (0.00%) 
Fatigue  1  1/53 (1.89%)  1/22 (4.55%)  0/73 (0.00%)  0/36 (0.00%)  0/3 (0.00%) 
General physical health deterioration  1  1/53 (1.89%)  0/22 (0.00%)  0/73 (0.00%)  3/36 (8.33%)  0/3 (0.00%) 
Generalised oedema  1  1/53 (1.89%)  0/22 (0.00%)  0/73 (0.00%)  0/36 (0.00%)  0/3 (0.00%) 
Hypothermia  1  0/53 (0.00%)  0/22 (0.00%)  1/73 (1.37%)  0/36 (0.00%)  0/3 (0.00%) 
Pyrexia  1  0/53 (0.00%)  1/22 (4.55%)  0/73 (0.00%)  0/36 (0.00%)  0/3 (0.00%) 
Sudden death  1  0/53 (0.00%)  1/22 (4.55%)  0/73 (0.00%)  0/36 (0.00%)  0/3 (0.00%) 
Non-cardiac chest pain  1  0/53 (0.00%)  0/22 (0.00%)  0/73 (0.00%)  2/36 (5.56%)  0/3 (0.00%) 
Hepatobiliary disorders           
Biliary colic  1  0/53 (0.00%)  1/22 (4.55%)  0/73 (0.00%)  0/36 (0.00%)  0/3 (0.00%) 
Bile duct stone  1  0/53 (0.00%)  0/22 (0.00%)  0/73 (0.00%)  1/36 (2.78%)  0/3 (0.00%) 
Cholecystitis  1  0/53 (0.00%)  0/22 (0.00%)  0/73 (0.00%)  1/36 (2.78%)  0/3 (0.00%) 
Infections and infestations           
Gastroenteritis  1  1/53 (1.89%)  0/22 (0.00%)  0/73 (0.00%)  0/36 (0.00%)  0/3 (0.00%) 
Infection  1  0/53 (0.00%)  0/22 (0.00%)  1/73 (1.37%)  0/36 (0.00%)  0/3 (0.00%) 
Influenza  1  1/53 (1.89%)  0/22 (0.00%)  1/73 (1.37%)  0/36 (0.00%)  0/3 (0.00%) 
Lower respiratory tract infection  1  0/53 (0.00%)  0/22 (0.00%)  1/73 (1.37%)  0/36 (0.00%)  0/3 (0.00%) 
Pneumonia  1  3/53 (5.66%)  1/22 (4.55%)  0/73 (0.00%)  0/36 (0.00%)  0/3 (0.00%) 
Pyelonephritis  1  1/53 (1.89%)  0/22 (0.00%)  0/73 (0.00%)  0/36 (0.00%)  0/3 (0.00%) 
Urinary tract infection  1  1/53 (1.89%)  0/22 (0.00%)  1/73 (1.37%)  0/36 (0.00%)  0/3 (0.00%) 
Enterococcal bacteraemia  1  0/53 (0.00%)  0/22 (0.00%)  0/73 (0.00%)  1/36 (2.78%)  0/3 (0.00%) 
Peritonitis  1  0/53 (0.00%)  0/22 (0.00%)  0/73 (0.00%)  1/36 (2.78%)  0/3 (0.00%) 
Sepsis  1  0/53 (0.00%)  0/22 (0.00%)  0/73 (0.00%)  1/36 (2.78%)  0/3 (0.00%) 
Injury, poisoning and procedural complications           
Subdural haematoma  1  0/53 (0.00%)  1/22 (4.55%)  0/73 (0.00%)  0/36 (0.00%)  0/3 (0.00%) 
Investigations           
Alanine aminotransferase increased  1  1/53 (1.89%)  0/22 (0.00%)  1/73 (1.37%)  0/36 (0.00%)  0/3 (0.00%) 
Aspartate aminotransferase increased  1  1/53 (1.89%)  0/22 (0.00%)  1/73 (1.37%)  0/36 (0.00%)  0/3 (0.00%) 
Electrocardiogram QT prolonged  1  1/53 (1.89%)  0/22 (0.00%)  0/73 (0.00%)  0/36 (0.00%)  0/3 (0.00%) 
Metabolism and nutrition disorders           
Dehydration  1  1/53 (1.89%)  0/22 (0.00%)  0/73 (0.00%)  0/36 (0.00%)  0/3 (0.00%) 
Hypercalcaemia  1  1/53 (1.89%)  0/22 (0.00%)  1/73 (1.37%)  0/36 (0.00%)  0/3 (0.00%) 
Hyperglycaemia  1  3/53 (5.66%)  1/22 (4.55%)  0/73 (0.00%)  0/36 (0.00%)  0/3 (0.00%) 
Hypoalbuminaemia  1  1/53 (1.89%)  0/22 (0.00%)  0/73 (0.00%)  0/36 (0.00%)  0/3 (0.00%) 
Hypokalaemia  1  0/53 (0.00%)  1/22 (4.55%)  1/73 (1.37%)  0/36 (0.00%)  0/3 (0.00%) 
Musculoskeletal and connective tissue disorders           
Back pain  1  0/53 (0.00%)  0/22 (0.00%)  1/73 (1.37%)  0/36 (0.00%)  0/3 (0.00%) 
Intervertabral disc protrusion  1  1/53 (1.89%)  0/22 (0.00%)  0/73 (0.00%)  0/36 (0.00%)  0/3 (0.00%) 
Mobility decreased  1  0/53 (0.00%)  0/22 (0.00%)  0/73 (0.00%)  1/36 (2.78%)  0/3 (0.00%) 
Pain in extremity  1  0/53 (0.00%)  0/22 (0.00%)  0/73 (0.00%)  1/36 (2.78%)  0/3 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Malignant neoplasm progression  1  5/53 (9.43%)  1/22 (4.55%)  2/73 (2.74%)  2/36 (5.56%)  0/3 (0.00%) 
Metastases to meninges  1  1/53 (1.89%)  0/22 (0.00%)  0/73 (0.00%)  1/36 (2.78%)  0/3 (0.00%) 
Metastatic pain  1  0/53 (0.00%)  0/22 (0.00%)  1/73 (1.37%)  1/36 (2.78%)  0/3 (0.00%) 
Nervous system disorders           
Complex partial seizures  1  0/53 (0.00%)  0/22 (0.00%)  1/73 (1.37%)  0/36 (0.00%)  0/3 (0.00%) 
Headache  1  0/53 (0.00%)  1/22 (4.55%)  0/73 (0.00%)  0/36 (0.00%)  0/3 (0.00%) 
Sciatica  1  1/53 (1.89%)  0/22 (0.00%)  0/73 (0.00%)  0/36 (0.00%)  0/3 (0.00%) 
Reproductive system and breast disorders           
Prostatic obstruction  1  1/53 (1.89%)  0/22 (0.00%)  0/73 (0.00%)  0/36 (0.00%)  0/3 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Dyspnoea  1  2/53 (3.77%)  0/22 (0.00%)  0/73 (0.00%)  1/36 (2.78%)  0/3 (0.00%) 
Haemoptysis  1  1/53 (1.89%)  0/22 (0.00%)  0/73 (0.00%)  0/36 (0.00%)  0/3 (0.00%) 
Hypoxia  1  0/53 (0.00%)  0/22 (0.00%)  1/73 (1.37%)  0/36 (0.00%)  0/3 (0.00%) 
Pleural effusion  1  0/53 (0.00%)  0/22 (0.00%)  2/73 (2.74%)  0/36 (0.00%)  1/3 (33.33%) 
Pneumonitis  1  1/53 (1.89%)  0/22 (0.00%)  0/73 (0.00%)  0/36 (0.00%)  0/3 (0.00%) 
Pneumothorax  1  1/53 (1.89%)  0/22 (0.00%)  0/73 (0.00%)  0/36 (0.00%)  0/3 (0.00%) 
Pulmonary embolism  1  0/53 (0.00%)  1/22 (4.55%)  0/73 (0.00%)  0/36 (0.00%)  0/3 (0.00%) 
1
Term from vocabulary, MedDRA 18.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rociletinib 500 mg BID Rociletinib 625 mg BID Chemotherapy Crossover From Chemotherapy to Rociletinib 500 mg BID Crossover From Chemotherapy to Rociletinib 625 mg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   53/53 (100.00%)   21/22 (95.45%)   71/73 (97.26%)   35/36 (97.22%)   3/3 (100.00%) 
Blood and lymphatic system disorders           
Anaemia  1  7/53 (13.21%)  2/22 (9.09%)  18/73 (24.66%)  5/36 (13.89%)  1/3 (33.33%) 
Leukopenia  1  1/53 (1.89%)  0/22 (0.00%)  5/73 (6.85%)  4/36 (11.11%)  0/3 (0.00%) 
Neutropenia  1  0/53 (0.00%)  2/22 (9.09%)  9/73 (12.33%)  2/36 (5.56%)  0/3 (0.00%) 
Thrombocytopenia  1  1/53 (1.89%)  0/22 (0.00%)  5/73 (6.85%)  2/36 (5.56%)  0/3 (0.00%) 
Eye disorders           
Cataract  1  5/53 (9.43%)  3/22 (13.64%)  1/73 (1.37%)  2/36 (5.56%)  0/3 (0.00%) 
Vision blurred  1  0/53 (0.00%)  0/22 (0.00%)  0/73 (0.00%)  0/36 (0.00%)  1/3 (33.33%) 
Gastrointestinal disorders           
Abdominal pain  1  6/53 (11.32%)  0/22 (0.00%)  3/73 (4.11%)  0/36 (0.00%)  0/3 (0.00%) 
Constipation  1  6/53 (11.32%)  2/22 (9.09%)  10/73 (13.70%)  3/36 (8.33%)  0/3 (0.00%) 
Diarrhoea  1  33/53 (62.26%)  15/22 (68.18%)  12/73 (16.44%)  13/36 (36.11%)  1/3 (33.33%) 
Dry mouth  1  3/53 (5.66%)  1/22 (4.55%)  2/73 (2.74%)  3/36 (8.33%)  0/3 (0.00%) 
Dyspepsia  1  3/53 (5.66%)  5/22 (22.73%)  1/73 (1.37%)  0/36 (0.00%)  0/3 (0.00%) 
Gastrooesophageal reflux disease  1  3/53 (5.66%)  2/22 (9.09%)  2/73 (2.74%)  2/36 (5.56%)  0/3 (0.00%) 
Nausea  1  19/53 (35.85%)  9/22 (40.91%)  20/73 (27.40%)  7/36 (19.44%)  1/3 (33.33%) 
Vomiting  1  10/53 (18.87%)  8/22 (36.36%)  6/73 (8.22%)  6/36 (16.67%)  2/3 (66.67%) 
Pancreatitis  1  0/53 (0.00%)  0/22 (0.00%)  0/73 (0.00%)  3/36 (8.33%)  0/3 (0.00%) 
General disorders           
Stomatitis  1  3/53 (5.66%)  1/22 (4.55%)  4/73 (5.48%)  0/36 (0.00%)  0/3 (0.00%) 
Asthenia  1  10/53 (18.87%)  1/22 (4.55%)  10/73 (13.70%)  3/36 (8.33%)  0/3 (0.00%) 
Chest discomfort  1  3/53 (5.66%)  0/22 (0.00%)  0/73 (0.00%)  0/36 (0.00%)  0/3 (0.00%) 
Chest pain  1  2/53 (3.77%)  2/22 (9.09%)  2/73 (2.74%)  0/36 (0.00%)  0/3 (0.00%) 
Fatigue  1  16/53 (30.19%)  12/22 (54.55%)  18/73 (24.66%)  4/36 (11.11%)  1/3 (33.33%) 
Non-cardiac chest pain  1  3/53 (5.66%)  0/22 (0.00%)  5/73 (6.85%)  3/36 (8.33%)  0/3 (0.00%) 
Oedema peripheral  1  5/53 (9.43%)  1/22 (4.55%)  6/73 (8.22%)  1/36 (2.78%)  0/3 (0.00%) 
Pyrexia  1  5/53 (9.43%)  2/22 (9.09%)  7/73 (9.59%)  0/36 (0.00%)  0/3 (0.00%) 
General physical health deterioration  1  0/53 (0.00%)  0/22 (0.00%)  0/73 (0.00%)  3/36 (8.33%)  0/3 (0.00%) 
Infections and infestations           
Nasopharyngitis  1  3/53 (5.66%)  0/22 (0.00%)  0/73 (0.00%)  0/36 (0.00%)  0/3 (0.00%) 
Pneumonia  1  4/53 (7.55%)  2/22 (9.09%)  0/73 (0.00%)  1/36 (2.78%)  0/3 (0.00%) 
Upper respiratory tract infection  1  4/53 (7.55%)  2/22 (9.09%)  3/73 (4.11%)  0/36 (0.00%)  0/3 (0.00%) 
Urinary tract infection  1  4/53 (7.55%)  1/22 (4.55%)  2/73 (2.74%)  0/36 (0.00%)  0/3 (0.00%) 
Investigations           
Alanine aminotransferase increased  1  4/53 (7.55%)  2/22 (9.09%)  4/73 (5.48%)  0/36 (0.00%)  0/3 (0.00%) 
Aspartate aminotransferase increased  1  5/53 (9.43%)  1/22 (4.55%)  5/73 (6.85%)  1/36 (2.78%)  0/3 (0.00%) 
Blood alkaline phosphatase increased  1  3/53 (5.66%)  0/22 (0.00%)  3/73 (4.11%)  1/36 (2.78%)  0/3 (0.00%) 
Blood bilirubin increased  1  4/53 (7.55%)  4/22 (18.18%)  1/73 (1.37%)  2/36 (5.56%)  0/3 (0.00%) 
Blood creatinine increased  1  4/53 (7.55%)  1/22 (4.55%)  3/73 (4.11%)  1/36 (2.78%)  0/3 (0.00%) 
Electrocardiogram QT prolonged  1  10/53 (18.87%)  10/22 (45.45%)  0/73 (0.00%)  7/36 (19.44%)  1/3 (33.33%) 
Lymphocyte count decreased  1  2/53 (3.77%)  1/22 (4.55%)  4/73 (5.48%)  1/36 (2.78%)  0/3 (0.00%) 
Neutrophil count decreased  1  2/53 (3.77%)  0/22 (0.00%)  10/73 (13.70%)  0/36 (0.00%)  0/3 (0.00%) 
Platelet count decreased  1  3/53 (5.66%)  1/22 (4.55%)  4/73 (5.48%)  0/36 (0.00%)  0/3 (0.00%) 
Weight decreased  1  10/53 (18.87%)  4/22 (18.18%)  4/73 (5.48%)  1/36 (2.78%)  1/3 (33.33%) 
White blood cell count decreased  1  2/53 (3.77%)  3/22 (13.64%)  9/73 (12.33%)  1/36 (2.78%)  0/3 (0.00%) 
Metabolism and nutrition disorders           
Decreased appetite  1  19/53 (35.85%)  9/22 (40.91%)  10/73 (13.70%)  8/36 (22.22%)  1/3 (33.33%) 
Hyperglycaemia  1  30/53 (56.60%)  14/22 (63.64%)  6/73 (8.22%)  12/36 (33.33%)  2/3 (66.67%) 
Hypokalaemia  1  7/53 (13.21%)  6/22 (27.27%)  3/73 (4.11%)  2/36 (5.56%)  0/3 (0.00%) 
Hypomagnesaemia  1  4/53 (7.55%)  2/22 (9.09%)  4/73 (5.48%)  0/36 (0.00%)  0/3 (0.00%) 
Hyponatraemia  1  1/53 (1.89%)  3/22 (13.64%)  2/73 (2.74%)  2/36 (5.56%)  0/3 (0.00%) 
Musculoskeletal and connective tissue disorders           
Arthralgia  1  5/53 (9.43%)  0/22 (0.00%)  6/73 (8.22%)  3/36 (8.33%)  0/3 (0.00%) 
Back pain  1  6/53 (11.32%)  3/22 (13.64%)  10/73 (13.70%)  1/36 (2.78%)  2/3 (66.67%) 
Bone pain  1  0/53 (0.00%)  0/22 (0.00%)  4/73 (5.48%)  0/36 (0.00%)  0/3 (0.00%) 
Flank pain  1  0/53 (0.00%)  2/22 (9.09%)  1/73 (1.37%)  0/36 (0.00%)  0/3 (0.00%) 
Muscle spasms  1  8/53 (15.09%)  3/22 (13.64%)  0/73 (0.00%)  3/36 (8.33%)  1/3 (33.33%) 
Muscular weakness  1  1/53 (1.89%)  2/22 (9.09%)  2/73 (2.74%)  0/36 (0.00%)  0/3 (0.00%) 
Musculoskeletal chest pain  1  3/53 (5.66%)  2/22 (9.09%)  6/73 (8.22%)  1/36 (2.78%)  0/3 (0.00%) 
Musculoskeletal pain  1  6/53 (11.32%)  2/22 (9.09%)  3/73 (4.11%)  4/36 (11.11%)  0/3 (0.00%) 
Myalgia  1  7/53 (13.21%)  3/22 (13.64%)  2/73 (2.74%)  1/36 (2.78%)  0/3 (0.00%) 
Pain in extremity  1  1/53 (1.89%)  0/22 (0.00%)  4/73 (5.48%)  4/36 (11.11%)  0/3 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Malignant neoplasm progression  1  7/53 (13.21%)  1/22 (4.55%)  2/73 (2.74%)  2/36 (5.56%)  1/3 (33.33%) 
Nervous system disorders           
Dizziness  1  4/53 (7.55%)  3/22 (13.64%)  2/73 (2.74%)  2/36 (5.56%)  0/3 (0.00%) 
Headache  1  6/53 (11.32%)  5/22 (22.73%)  5/73 (6.85%)  1/36 (2.78%)  1/3 (33.33%) 
Migraine  1  0/53 (0.00%)  0/22 (0.00%)  0/73 (0.00%)  0/36 (0.00%)  1/3 (33.33%) 
Paraesthesia  1  0/53 (0.00%)  0/22 (0.00%)  0/73 (0.00%)  2/36 (5.56%)  0/3 (0.00%) 
Psychiatric disorders           
Anxiety  1  1/53 (1.89%)  1/22 (4.55%)  4/73 (5.48%)  0/36 (0.00%)  0/3 (0.00%) 
Insomnia  1  8/53 (15.09%)  1/22 (4.55%)  10/73 (13.70%)  2/36 (5.56%)  0/3 (0.00%) 
Renal and urinary disorders           
Dysuria  1  0/53 (0.00%)  0/22 (0.00%)  4/73 (5.48%)  1/36 (2.78%)  0/3 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Cough  1  15/53 (28.30%)  6/22 (27.27%)  14/73 (19.18%)  3/36 (8.33%)  0/3 (0.00%) 
Dyspnoea  1  8/53 (15.09%)  5/22 (22.73%)  10/73 (13.70%)  6/36 (16.67%)  0/3 (0.00%) 
Oropharyngeal pain  1  6/53 (11.32%)  1/22 (4.55%)  2/73 (2.74%)  0/36 (0.00%)  0/3 (0.00%) 
Pleural effusion  1  0/53 (0.00%)  0/22 (0.00%)  4/73 (5.48%)  0/36 (0.00%)  1/3 (33.33%) 
Pneumonitis  1  4/53 (7.55%)  0/22 (0.00%)  0/73 (0.00%)  1/36 (2.78%)  0/3 (0.00%) 
Pulmonary embolism  1  0/53 (0.00%)  2/22 (9.09%)  0/73 (0.00%)  0/36 (0.00%)  0/3 (0.00%) 
Epistaxis  1  0/53 (0.00%)  0/22 (0.00%)  0/73 (0.00%)  2/36 (5.56%)  0/3 (0.00%) 
Haemoptysis  1  0/53 (0.00%)  0/22 (0.00%)  0/73 (0.00%)  2/36 (5.56%)  0/3 (0.00%) 
Sputum increased  1  0/53 (0.00%)  0/22 (0.00%)  0/73 (0.00%)  0/36 (0.00%)  1/3 (33.33%) 
Skin and subcutaneous tissue disorders           
Alopecia  1  3/53 (5.66%)  0/22 (0.00%)  8/73 (10.96%)  0/36 (0.00%)  0/3 (0.00%) 
Rash  1  5/53 (9.43%)  0/22 (0.00%)  4/73 (5.48%)  0/36 (0.00%)  0/3 (0.00%) 
Dry skin  1  0/53 (0.00%)  0/22 (0.00%)  0/73 (0.00%)  2/36 (5.56%)  0/3 (0.00%) 
Vascular disorders           
Hypertension  1  6/53 (11.32%)  0/22 (0.00%)  2/73 (2.74%)  0/36 (0.00%)  0/3 (0.00%) 
1
Term from vocabulary, MedDRA 18.0
Indicates events were collected by systematic assessment
Due to early study termination, only 149 of 600 planned patients were randomized.
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.
All parties agree to submit all manuscripts or abstracts to all other parties 30 days prior to submission. This will enable all parties to protect proprietary information and to provide comments based on information that may not yet be available to other parties. The sponsor may request a delay in publication if there are important intellectual property concerns relating to publication, but does not have the right to suppress publication of the study results indefinitely.
Results Point of Contact
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Name/Title: Vi Nguyen
Organization: Clovis Oncology
Phone: +1 415 915 9982
EMail: vnguyen@clovisoncology.com
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Responsible Party: Clovis Oncology, Inc.
ClinicalTrials.gov Identifier: NCT02322281    
Other Study ID Numbers: CO-1686-020 (TIGER-3)
First Submitted: December 17, 2014
First Posted: December 23, 2014
Results First Submitted: March 19, 2019
Results First Posted: July 23, 2019
Last Update Posted: August 14, 2019