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Trial record 4 of 109 for:    hedgehog

A Study of Vismodegib (GDC-0449, Hedgehog Pathway Inhibitor) With Concurrent Chemotherapy and Bevacizumab As First-Line Therapy for Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00636610
Recruitment Status : Completed
First Posted : March 14, 2008
Results First Posted : July 3, 2012
Last Update Posted : June 8, 2017
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Metastatic Colorectal Cancer
Interventions Drug: Vismodegib 150 mg
Drug: Placebo to vismodegib
Drug: Bevacizumab
Drug: Modified FOLFOX
Drug: FOLFIRI
Enrollment 199

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vismodegib 150 mg Placebo to Vismodegib
Hide Arm/Group Description Patients received vismodegib 150 mg orally once daily starting on Day 3 of each 2-week treatment cycle. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient. Patients received placebo to vismodegib orally once daily starting on Day 3 of each 2-week treatment. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
Period Title: Overall Study
Started 98 101
Completed 6 18
Not Completed 92 83
Reason Not Completed
Adverse Event             4             4
Death             6             3
Physician decision to withdraw patient             15             9
Subject decision to withdraw             15             11
Disease progression - radiographic             41             51
Disease progression - clinical             8             3
Reason for discontinuation not available             3             2
Arm/Group Title Vismodegib 150 mg Placebo to Vismodegib Total
Hide Arm/Group Description Patients received vismodegib 150 mg orally once daily starting on Day 3 of each 2-week treatment cycle. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient. Patients received placebo to vismodegib orally once daily starting on Day 3 of each 2-week treatment. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient. Total of all reporting groups
Overall Number of Baseline Participants 98 101 199
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 98 participants 101 participants 199 participants
60.8  (10.4) 60.4  (11.0) 60.6  (10.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 101 participants 199 participants
Female
39
  39.8%
46
  45.5%
85
  42.7%
Male
59
  60.2%
55
  54.5%
114
  57.3%
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description Progression-free survival (PFS) was defined as the time from randomization to the earlier of documented disease progression (PD) or death from any cause. PD: At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started, unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions. For patients without measurable disease, PD was defined as an increase in the size of a lesion to one that is measurable or unequivocal progression of a non-target lesion.
Time Frame From first treatment through the data cut-off date of March 15, 2010, up to 90 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat patient population: All randomized patients.
Arm/Group Title Vismodegib 150 mg Placebo to Vismodegib
Hide Arm/Group Description:
Patients received vismodegib 150 mg orally once daily starting on Day 3 of each 2-week treatment cycle. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
Patients received placebo to vismodegib orally once daily starting on Day 3 of each 2-week treatment. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
Overall Number of Participants Analyzed 98 101
Median (90% Confidence Interval)
Unit of Measure: Months
9.3
(7.98 to 10.51)
10.1
(9.43 to 11.33)
2.Secondary Outcome
Title Progression-free Survival (PFS) in Patients With Various Degrees of Hedgehog Antigen Tumor Expression
Hide Description Indian + Sonic Hedgehog antigen expression was measured by quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) from archival tumor tissue taken from each patient prior to enrollment in the study. Results are reported in 3 categories; the 33% of patients with the lowest level of expression, the 35% of patients with a middle level of expression, and the 32% of patients with the highest level of expression. PFS was defined as the time between randomization and disease progression, as confirmed by radiography, or death for any reason.
Time Frame From first treatment through the data cut-off date of March 15, 2010, up to 90 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat patient population: All randomized patients. Tissue for evaluation was only available for 64 patients in the vismodegib group and 75 patients in the placebo group.
Arm/Group Title Vismodegib 150 mg Placebo to Vismodegib
Hide Arm/Group Description:
Patients received vismodegib 150 mg orally once daily starting on Day 3 of each 2-week treatment cycle. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
Patients received placebo to vismodegib orally once daily starting on Day 3 of each 2-week treatment. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
Overall Number of Participants Analyzed 64 75
Median (90% Confidence Interval)
Unit of Measure: Months
≤ 33%, n=(16,30)
9.2
(3.6 to 15.9)
9.4
(7.0 to 11.3)
33% - 67%, n=(18,28)
7.4
(5.8 to 8.2)
11.3
(7.1 to 15.8)
> 67%, n=(30,17)
10.7
(7.9 to 11.5)
14.4 [1] 
(5.3 to NA)
[1]
The upper limit of the confidence interval could not be estimated due to sparse data above the median.
Time Frame Adverse events and serious adverse events were recorded starting at the time of informed consent until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 124 weeks.
Adverse Event Reporting Description Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of investigational drug treatment.
 
Arm/Group Title Placebo With FOLFOX+Bevacizumab Vismodegib (GDC-0449) With FOLFOX+Bevacizumab Placebo With FOLFIRI+Bevacizumab Vismodegib (GDC-0449) With FOLFIRI+Bevacizumab
Hide Arm/Group Description Placebo will be administered beginning on Cycle 1, Day 3 once daily by oral dosing. For Cycles 2 and beyond, placebo will be administered once daily beginning on Day 1. GDC-0449 (150 mg) will be administered beginning on Cycle 1, Day 3 once daily by oral dosing. For Cycles 2 and beyond, GDC-0449 will be administered once daily beginning on Day 1. Placebo will be administered beginning on Cycle 1, Day 3 once daily by oral dosing. For Cycles 2 and beyond, placebo will be administered once daily beginning on Day 1. GDC-0449 (150 mg) will be administered beginning on Cycle 1, Day 3 once daily by oral dosing. For Cycles 2 and beyond, GDC-0449 will be administered once daily beginning on Day 1.
All-Cause Mortality
Placebo With FOLFOX+Bevacizumab Vismodegib (GDC-0449) With FOLFOX+Bevacizumab Placebo With FOLFIRI+Bevacizumab Vismodegib (GDC-0449) With FOLFIRI+Bevacizumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo With FOLFOX+Bevacizumab Vismodegib (GDC-0449) With FOLFOX+Bevacizumab Placebo With FOLFIRI+Bevacizumab Vismodegib (GDC-0449) With FOLFIRI+Bevacizumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   21/62 (33.87%)   29/61 (47.54%)   9/36 (25.00%)   18/37 (48.65%) 
Blood and lymphatic system disorders         
Coagulopathy  1  0/62 (0.00%)  0/61 (0.00%)  0/36 (0.00%)  1/37 (2.70%) 
Febrile Neutropenia  1  0/62 (0.00%)  1/61 (1.64%)  1/36 (2.78%)  0/37 (0.00%) 
Neutropenia  1  0/62 (0.00%)  1/61 (1.64%)  0/36 (0.00%)  0/37 (0.00%) 
Anaemia  1  1/62 (1.61%)  0/61 (0.00%)  0/36 (0.00%)  0/37 (0.00%) 
Thrombocytopenia  1  1/62 (1.61%)  0/61 (0.00%)  0/36 (0.00%)  0/37 (0.00%) 
Cardiac disorders         
Acute Myocardial Infarction  1  1/62 (1.61%)  0/61 (0.00%)  0/36 (0.00%)  0/37 (0.00%) 
Atrial Fibrillation  1  0/62 (0.00%)  0/61 (0.00%)  1/36 (2.78%)  0/37 (0.00%) 
Cardiac Failure Congestive  1  1/62 (1.61%)  0/61 (0.00%)  0/36 (0.00%)  0/37 (0.00%) 
Gastrointestinal disorders         
Abdominal Pain  1  1/62 (1.61%)  2/61 (3.28%)  0/36 (0.00%)  1/37 (2.70%) 
Ileus  1  0/62 (0.00%)  3/61 (4.92%)  0/36 (0.00%)  0/37 (0.00%) 
Nausea  1  1/62 (1.61%)  2/61 (3.28%)  0/36 (0.00%)  1/37 (2.70%) 
Vomiting  1  1/62 (1.61%)  2/61 (3.28%)  0/36 (0.00%)  1/37 (2.70%) 
Diarrhoea  1  1/62 (1.61%)  0/61 (0.00%)  1/36 (2.78%)  2/37 (5.41%) 
Intestinal Obstruction  1  0/62 (0.00%)  2/61 (3.28%)  1/36 (2.78%)  0/37 (0.00%) 
Small Intestinal Obstruction  1  2/62 (3.23%)  2/61 (3.28%)  0/36 (0.00%)  0/37 (0.00%) 
Colitis  1  0/62 (0.00%)  0/61 (0.00%)  0/36 (0.00%)  1/37 (2.70%) 
Colonic Obstruction  1  0/62 (0.00%)  0/61 (0.00%)  0/36 (0.00%)  1/37 (2.70%) 
Duodenal Ulcer  1  0/62 (0.00%)  1/61 (1.64%)  0/36 (0.00%)  0/37 (0.00%) 
Enteritis  1  0/62 (0.00%)  0/61 (0.00%)  0/36 (0.00%)  1/37 (2.70%) 
Erosive Oesophagitis  1  0/62 (0.00%)  0/61 (0.00%)  0/36 (0.00%)  1/37 (2.70%) 
Oesophageal Ulcer  1  0/62 (0.00%)  1/61 (1.64%)  0/36 (0.00%)  0/37 (0.00%) 
Oesophagitis  1  0/62 (0.00%)  1/61 (1.64%)  0/36 (0.00%)  0/37 (0.00%) 
Stomatitis  1  0/62 (0.00%)  0/61 (0.00%)  0/36 (0.00%)  1/37 (2.70%) 
Anal Fissure  1  1/62 (1.61%)  0/61 (0.00%)  0/36 (0.00%)  0/37 (0.00%) 
Large Intestine Perforation  1  0/62 (0.00%)  0/61 (0.00%)  1/36 (2.78%)  0/37 (0.00%) 
Small Intestinal Perforation  1  1/62 (1.61%)  0/61 (0.00%)  0/36 (0.00%)  0/37 (0.00%) 
General disorders         
Mucosal Inflammation  1  0/62 (0.00%)  3/61 (4.92%)  0/36 (0.00%)  0/37 (0.00%) 
Asthenia  1  0/62 (0.00%)  1/61 (1.64%)  0/36 (0.00%)  1/37 (2.70%) 
Chest Pain  1  1/62 (1.61%)  1/61 (1.64%)  1/36 (2.78%)  0/37 (0.00%) 
Pain  1  0/62 (0.00%)  1/61 (1.64%)  0/36 (0.00%)  0/37 (0.00%) 
Pyrexia  1  1/62 (1.61%)  0/61 (0.00%)  0/36 (0.00%)  1/37 (2.70%) 
Sudden Death  1  0/62 (0.00%)  1/61 (1.64%)  0/36 (0.00%)  0/37 (0.00%) 
Hepatobiliary disorders         
Cholecystitis  1  0/62 (0.00%)  1/61 (1.64%)  0/36 (0.00%)  0/37 (0.00%) 
Cholecystitis Acute  1  1/62 (1.61%)  0/61 (0.00%)  0/36 (0.00%)  0/37 (0.00%) 
Infections and infestations         
Pneumonia  1  1/62 (1.61%)  2/61 (3.28%)  1/36 (2.78%)  1/37 (2.70%) 
Breast Infection  1  0/62 (0.00%)  1/61 (1.64%)  0/36 (0.00%)  0/37 (0.00%) 
Clostridium Difficile Colitis  1  0/62 (0.00%)  1/61 (1.64%)  0/36 (0.00%)  0/37 (0.00%) 
Diverticulitis  1  0/62 (0.00%)  1/61 (1.64%)  0/36 (0.00%)  0/37 (0.00%) 
Escherichia Sepsis  1  0/62 (0.00%)  1/61 (1.64%)  0/36 (0.00%)  0/37 (0.00%) 
Gastroenteritis  1  0/62 (0.00%)  1/61 (1.64%)  0/36 (0.00%)  0/37 (0.00%) 
Sepsis  1  0/62 (0.00%)  0/61 (0.00%)  1/36 (2.78%)  1/37 (2.70%) 
Urinary Tract Infection  1  1/62 (1.61%)  1/61 (1.64%)  0/36 (0.00%)  0/37 (0.00%) 
Abdominal Abscess  1  1/62 (1.61%)  0/61 (0.00%)  0/36 (0.00%)  0/37 (0.00%) 
Appendicitis Perforated  1  1/62 (1.61%)  0/61 (0.00%)  0/36 (0.00%)  0/37 (0.00%) 
Catheter Site Infection  1  0/62 (0.00%)  0/61 (0.00%)  1/36 (2.78%)  0/37 (0.00%) 
Gastroenteritis Viral  1  1/62 (1.61%)  0/61 (0.00%)  0/36 (0.00%)  0/37 (0.00%) 
Perirectal Abscess  1  2/62 (3.23%)  0/61 (0.00%)  0/36 (0.00%)  0/37 (0.00%) 
Injury, poisoning and procedural complications         
Gastrointestinal Stoma Complication  1  0/62 (0.00%)  0/61 (0.00%)  0/36 (0.00%)  1/37 (2.70%) 
Hip Fracture  1  2/62 (3.23%)  0/61 (0.00%)  0/36 (0.00%)  0/37 (0.00%) 
Spinal Compression Fracture  1  1/62 (1.61%)  0/61 (0.00%)  0/36 (0.00%)  0/37 (0.00%) 
Investigations         
Weight Decreased  1  0/62 (0.00%)  0/61 (0.00%)  0/36 (0.00%)  1/37 (2.70%) 
Metabolism and nutrition disorders         
Dehydration  1  2/62 (3.23%)  7/61 (11.48%)  0/36 (0.00%)  2/37 (5.41%) 
Decreased Appetite  1  0/62 (0.00%)  1/61 (1.64%)  0/36 (0.00%)  0/37 (0.00%) 
Diabetic Ketoacidosis  1  0/62 (0.00%)  1/61 (1.64%)  0/36 (0.00%)  0/37 (0.00%) 
Hyperglycaemia  1  0/62 (0.00%)  1/61 (1.64%)  0/36 (0.00%)  0/37 (0.00%) 
Hypoglycaemia  1  1/62 (1.61%)  0/61 (0.00%)  0/36 (0.00%)  1/37 (2.70%) 
Hypokalaemia  1  0/62 (0.00%)  1/61 (1.64%)  0/36 (0.00%)  0/37 (0.00%) 
Metabolic Acidosis  1  0/62 (0.00%)  1/61 (1.64%)  0/36 (0.00%)  0/37 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  0/62 (0.00%)  0/61 (0.00%)  1/36 (2.78%)  0/37 (0.00%) 
Coccydynia  1  0/62 (0.00%)  0/61 (0.00%)  1/36 (2.78%)  0/37 (0.00%) 
Nervous system disorders         
Cerebrovascular Accident  1  0/62 (0.00%)  0/61 (0.00%)  0/36 (0.00%)  1/37 (2.70%) 
Convulsion  1  0/62 (0.00%)  1/61 (1.64%)  1/36 (2.78%)  0/37 (0.00%) 
Reversible Posterior Leukoencephalopathy Syndrome  1  0/62 (0.00%)  1/61 (1.64%)  0/36 (0.00%)  0/37 (0.00%) 
Syncope  1  0/62 (0.00%)  1/61 (1.64%)  0/36 (0.00%)  0/37 (0.00%) 
Transient Ischaemic Attack  1  1/62 (1.61%)  0/61 (0.00%)  0/36 (0.00%)  0/37 (0.00%) 
Psychiatric disorders         
Psychotic Disorder  1  0/62 (0.00%)  0/61 (0.00%)  1/36 (2.78%)  0/37 (0.00%) 
Renal and urinary disorders         
Renal Failure Acute  1  1/62 (1.61%)  3/61 (4.92%)  0/36 (0.00%)  0/37 (0.00%) 
Renal Failure  1  0/62 (0.00%)  0/61 (0.00%)  0/36 (0.00%)  1/37 (2.70%) 
Ureteric Obstruction  1  0/62 (0.00%)  0/61 (0.00%)  0/36 (0.00%)  1/37 (2.70%) 
Nephrolithiasis  1  1/62 (1.61%)  0/61 (0.00%)  0/36 (0.00%)  0/37 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Pulmonary Embolism  1  1/62 (1.61%)  5/61 (8.20%)  3/36 (8.33%)  2/37 (5.41%) 
Dyspnoea  1  0/62 (0.00%)  2/61 (3.28%)  0/36 (0.00%)  1/37 (2.70%) 
Chronic Obstructive Pulmonary Disease  1  0/62 (0.00%)  0/61 (0.00%)  0/36 (0.00%)  1/37 (2.70%) 
Lung Infiltration  1  0/62 (0.00%)  1/61 (1.64%)  0/36 (0.00%)  0/37 (0.00%) 
Pneumonia Aspiration  1  0/62 (0.00%)  1/61 (1.64%)  0/36 (0.00%)  0/37 (0.00%) 
Respiratory Failure  1  0/62 (0.00%)  1/61 (1.64%)  0/36 (0.00%)  0/37 (0.00%) 
Epistaxis  1  0/62 (0.00%)  0/61 (0.00%)  1/36 (2.78%)  0/37 (0.00%) 
Vascular disorders         
Deep Vein Thrombosis  1  0/62 (0.00%)  4/61 (6.56%)  1/36 (2.78%)  0/37 (0.00%) 
Hypotension  1  0/62 (0.00%)  1/61 (1.64%)  0/36 (0.00%)  0/37 (0.00%) 
Vena Cava Thrombosis  1  0/62 (0.00%)  0/61 (0.00%)  0/36 (0.00%)  1/37 (2.70%) 
Malignant Hypertension  1  0/62 (0.00%)  0/61 (0.00%)  1/36 (2.78%)  0/37 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo With FOLFOX+Bevacizumab Vismodegib (GDC-0449) With FOLFOX+Bevacizumab Placebo With FOLFIRI+Bevacizumab Vismodegib (GDC-0449) With FOLFIRI+Bevacizumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   62/62 (100.00%)   61/61 (100.00%)   36/36 (100.00%)   36/37 (97.30%) 
Blood and lymphatic system disorders         
Neutropenia  1  26/62 (41.94%)  19/61 (31.15%)  13/36 (36.11%)  14/37 (37.84%) 
Anaemia  1  21/62 (33.87%)  14/61 (22.95%)  11/36 (30.56%)  6/37 (16.22%) 
Thrombocytopenia  1  19/62 (30.65%)  9/61 (14.75%)  5/36 (13.89%)  2/37 (5.41%) 
Leukopenia  1  11/62 (17.74%)  6/61 (9.84%)  6/36 (16.67%)  4/37 (10.81%) 
Lymphopenia  1  4/62 (6.45%)  1/61 (1.64%)  1/36 (2.78%)  1/37 (2.70%) 
Eye disorders         
Lacrimation Increased  1  2/62 (3.23%)  3/61 (4.92%)  1/36 (2.78%)  6/37 (16.22%) 
Gastrointestinal disorders         
Nausea  1  40/62 (64.52%)  38/61 (62.30%)  21/36 (58.33%)  23/37 (62.16%) 
Diarrhoea  1  36/62 (58.06%)  30/61 (49.18%)  29/36 (80.56%)  22/37 (59.46%) 
Vomiting  1  16/62 (25.81%)  23/61 (37.70%)  15/36 (41.67%)  19/37 (51.35%) 
Constipation  1  21/62 (33.87%)  20/61 (32.79%)  13/36 (36.11%)  12/37 (32.43%) 
Abdominal Pain  1  13/62 (20.97%)  12/61 (19.67%)  8/36 (22.22%)  6/37 (16.22%) 
Stomatitis  1  12/62 (19.35%)  8/61 (13.11%)  3/36 (8.33%)  7/37 (18.92%) 
Dyspepsia  1  9/62 (14.52%)  6/61 (9.84%)  5/36 (13.89%)  8/37 (21.62%) 
Abdominal Pain Upper  1  2/62 (3.23%)  5/61 (8.20%)  3/36 (8.33%)  3/37 (8.11%) 
Gastrooesophageal Reflux Disease  1  3/62 (4.84%)  4/61 (6.56%)  4/36 (11.11%)  3/37 (8.11%) 
Oral Pain  1  4/62 (6.45%)  2/61 (3.28%)  1/36 (2.78%)  4/37 (10.81%) 
Rectal Haemorrhage  1  4/62 (6.45%)  4/61 (6.56%)  3/36 (8.33%)  2/37 (5.41%) 
Haemorrhoids  1  1/62 (1.61%)  2/61 (3.28%)  8/36 (22.22%)  3/37 (8.11%) 
Dysphagia  1  5/62 (8.06%)  2/61 (3.28%)  1/36 (2.78%)  1/37 (2.70%) 
Flatulence  1  4/62 (6.45%)  0/61 (0.00%)  1/36 (2.78%)  2/37 (5.41%) 
Proctalgia  1  3/62 (4.84%)  1/61 (1.64%)  4/36 (11.11%)  1/37 (2.70%) 
General disorders         
Fatigue  1  42/62 (67.74%)  40/61 (65.57%)  29/36 (80.56%)  27/37 (72.97%) 
Mucosal Inflammation  1  16/62 (25.81%)  15/61 (24.59%)  8/36 (22.22%)  13/37 (35.14%) 
Asthenia  1  6/62 (9.68%)  10/61 (16.39%)  3/36 (8.33%)  9/37 (24.32%) 
Temperature Intolerance  1  20/62 (32.26%)  12/61 (19.67%)  0/36 (0.00%)  1/37 (2.70%) 
Pyrexia  1  3/62 (4.84%)  7/61 (11.48%)  6/36 (16.67%)  5/37 (13.51%) 
Chest Pain  1  3/62 (4.84%)  5/61 (8.20%)  2/36 (5.56%)  4/37 (10.81%) 
Oedema Peripheral  1  3/62 (4.84%)  6/61 (9.84%)  7/36 (19.44%)  2/37 (5.41%) 
Pain  1  3/62 (4.84%)  5/61 (8.20%)  3/36 (8.33%)  0/37 (0.00%) 
Chills  1  4/62 (6.45%)  3/61 (4.92%)  1/36 (2.78%)  1/37 (2.70%) 
Immune system disorders         
Seasonal Allergy  1  2/62 (3.23%)  0/61 (0.00%)  4/36 (11.11%)  0/37 (0.00%) 
Infections and infestations         
Urinary Tract Infection  1  5/62 (8.06%)  11/61 (18.03%)  8/36 (22.22%)  5/37 (13.51%) 
Sinusitis  1  1/62 (1.61%)  5/61 (8.20%)  3/36 (8.33%)  4/37 (10.81%) 
Oral Candidiasis  1  0/62 (0.00%)  2/61 (3.28%)  0/36 (0.00%)  3/37 (8.11%) 
Pneumonia  1  1/62 (1.61%)  3/61 (4.92%)  3/36 (8.33%)  2/37 (5.41%) 
Upper Respiratory Tract Infection  1  6/62 (9.68%)  3/61 (4.92%)  4/36 (11.11%)  0/37 (0.00%) 
Injury, poisoning and procedural complications         
Contusion  1  1/62 (1.61%)  4/61 (6.56%)  3/36 (8.33%)  1/37 (2.70%) 
Fall  1  2/62 (3.23%)  2/61 (3.28%)  1/36 (2.78%)  3/37 (8.11%) 
Investigations         
Weight Decreased  1  9/62 (14.52%)  20/61 (32.79%)  4/36 (11.11%)  15/37 (40.54%) 
Blood Alkaline Phosphatase Increased  1  5/62 (8.06%)  3/61 (4.92%)  2/36 (5.56%)  3/37 (8.11%) 
Alanine Aminotransferase Increased  1  5/62 (8.06%)  1/61 (1.64%)  2/36 (5.56%)  2/37 (5.41%) 
Aspartate Aminotransferase Increased  1  6/62 (9.68%)  1/61 (1.64%)  2/36 (5.56%)  2/37 (5.41%) 
Metabolism and nutrition disorders         
Decreased Appetite  1  14/62 (22.58%)  31/61 (50.82%)  10/36 (27.78%)  18/37 (48.65%) 
Dehydration  1  6/62 (9.68%)  13/61 (21.31%)  3/36 (8.33%)  11/37 (29.73%) 
Hypokalaemia  1  6/62 (9.68%)  10/61 (16.39%)  4/36 (11.11%)  3/37 (8.11%) 
Hypomagnesaemia  1  5/62 (8.06%)  8/61 (13.11%)  3/36 (8.33%)  2/37 (5.41%) 
Hyperglycaemia  1  8/62 (12.90%)  5/61 (8.20%)  2/36 (5.56%)  2/37 (5.41%) 
Musculoskeletal and connective tissue disorders         
Muscle Spasms  1  1/62 (1.61%)  7/61 (11.48%)  1/36 (2.78%)  9/37 (24.32%) 
Arthralgia  1  12/62 (19.35%)  7/61 (11.48%)  4/36 (11.11%)  5/37 (13.51%) 
Pain In Extremity  1  6/62 (9.68%)  7/61 (11.48%)  7/36 (19.44%)  4/37 (10.81%) 
Back Pain  1  6/62 (9.68%)  4/61 (6.56%)  6/36 (16.67%)  5/37 (13.51%) 
Musculoskeletal Pain  1  1/62 (1.61%)  5/61 (8.20%)  4/36 (11.11%)  2/37 (5.41%) 
Myalgia  1  1/62 (1.61%)  1/61 (1.64%)  3/36 (8.33%)  4/37 (10.81%) 
Neck Pain  1  4/62 (6.45%)  2/61 (3.28%)  2/36 (5.56%)  1/37 (2.70%) 
Musculoskeletal Chest Pain  1  3/62 (4.84%)  1/61 (1.64%)  2/36 (5.56%)  1/37 (2.70%) 
Nervous system disorders         
Dysgeusia  1  8/62 (12.90%)  29/61 (47.54%)  1/36 (2.78%)  12/37 (32.43%) 
Neuropathy Peripheral  1  34/62 (54.84%)  19/61 (31.15%)  6/36 (16.67%)  2/37 (5.41%) 
Peripheral Sensory Neuropathy  1  14/62 (22.58%)  20/61 (32.79%)  4/36 (11.11%)  1/37 (2.70%) 
Dizziness  1  10/62 (16.13%)  14/61 (22.95%)  2/36 (5.56%)  3/37 (8.11%) 
Headache  1  16/62 (25.81%)  9/61 (14.75%)  5/36 (13.89%)  5/37 (13.51%) 
Syncope  1  3/62 (4.84%)  4/61 (6.56%)  0/36 (0.00%)  2/37 (5.41%) 
Hypoaesthesia  1  2/62 (3.23%)  4/61 (6.56%)  0/36 (0.00%)  1/37 (2.70%) 
Psychiatric disorders         
Insomnia  1  11/62 (17.74%)  7/61 (11.48%)  9/36 (25.00%)  5/37 (13.51%) 
Anxiety  1  3/62 (4.84%)  4/61 (6.56%)  6/36 (16.67%)  7/37 (18.92%) 
Depression  1  3/62 (4.84%)  6/61 (9.84%)  5/36 (13.89%)  4/37 (10.81%) 
Renal and urinary disorders         
Proteinuria  1  9/62 (14.52%)  6/61 (9.84%)  6/36 (16.67%)  5/37 (13.51%) 
Respiratory, thoracic and mediastinal disorders         
Epistaxis  1  16/62 (25.81%)  16/61 (26.23%)  17/36 (47.22%)  6/37 (16.22%) 
Dyspnoea  1  6/62 (9.68%)  13/61 (21.31%)  4/36 (11.11%)  6/37 (16.22%) 
Cough  1  7/62 (11.29%)  9/61 (14.75%)  9/36 (25.00%)  6/37 (16.22%) 
Pulmonary Embolism  1  3/62 (4.84%)  5/61 (8.20%)  4/36 (11.11%)  2/37 (5.41%) 
Nasal Congestion  1  3/62 (4.84%)  5/61 (8.20%)  0/36 (0.00%)  0/37 (0.00%) 
Oropharyngeal Pain  1  1/62 (1.61%)  3/61 (4.92%)  3/36 (8.33%)  2/37 (5.41%) 
Rhinorrhoea  1  3/62 (4.84%)  1/61 (1.64%)  5/36 (13.89%)  3/37 (8.11%) 
Dysphonia  1  5/62 (8.06%)  1/61 (1.64%)  4/36 (11.11%)  1/37 (2.70%) 
Skin and subcutaneous tissue disorders         
Alopecia  1  9/62 (14.52%)  11/61 (18.03%)  9/36 (25.00%)  8/37 (21.62%) 
Rash  1  8/62 (12.90%)  6/61 (9.84%)  6/36 (16.67%)  1/37 (2.70%) 
Palmar−Plantar Erythrodysaesthesia Syndrome  1  4/62 (6.45%)  6/61 (9.84%)  6/36 (16.67%)  0/37 (0.00%) 
Erythema  1  3/62 (4.84%)  2/61 (3.28%)  5/36 (13.89%)  3/37 (8.11%) 
Hyperhidrosis  1  1/62 (1.61%)  3/61 (4.92%)  1/36 (2.78%)  2/37 (5.41%) 
Dry Skin  1  4/62 (6.45%)  2/61 (3.28%)  4/36 (11.11%)  2/37 (5.41%) 
Vascular disorders         
Hypertension  1  11/62 (17.74%)  6/61 (9.84%)  5/36 (13.89%)  5/37 (13.51%) 
Deep Vein Thrombosis  1  0/62 (0.00%)  6/61 (9.84%)  5/36 (13.89%)  2/37 (5.41%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
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
Name/Title: Medical Communications
Organization: Genentech, Inc.
Phone: 800-821-8590
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00636610     History of Changes
Other Study ID Numbers: SHH4429g
First Submitted: March 5, 2008
First Posted: March 14, 2008
Results First Submitted: February 14, 2012
Results First Posted: July 3, 2012
Last Update Posted: June 8, 2017