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A Study of Bevacizumab With Carboplatin and Paclitaxel Chemotherapy for the First-Line Treatment of Patients With Metastatic Melanoma (BEAM)

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ClinicalTrials.gov Identifier: NCT00434252
Recruitment Status : Completed
First Posted : February 13, 2007
Results First Posted : September 28, 2011
Last Update Posted : July 18, 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 Melanoma
Interventions Drug: bevacizumab
Drug: carboplatin
Drug: paclitaxel
Drug: placebo
Enrollment 214
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Carboplatin+Paclitaxel+Placebo Carboplatin+Paclitaxel+Bevacizumab
Hide Arm/Group Description Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo. Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
Period Title: Overall Study
Started 71 143
Treated 69 [1] 143
Completed 7 [2] 12 [2]
Not Completed 64 131
Reason Not Completed
Lack of Efficacy             50             100
Adverse Event             6             13
Death             1             2
Lost to Follow-up             0             1
Physician Decision             4             8
Withdrawal by Subject             3             7
[1]
One patient died and one patient withdrew prior to receiving study treatment
[2]
Continuing study drug treatment at the time of the data cutoff.
Arm/Group Title Carboplatin+Paclitaxel+Placebo Carboplatin+Paclitaxel+Bevacizumab Total
Hide Arm/Group Description Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo. Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab. Total of all reporting groups
Overall Number of Baseline Participants 71 143 214
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 71 participants 143 participants 214 participants
58.7  (12.6) 59.1  (11.3) 58.9  (11.7)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 71 participants 143 participants 214 participants
<= 65 years 46 104 150
> 65 years 25 39 64
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 143 participants 214 participants
Female
21
  29.6%
45
  31.5%
66
  30.8%
Male
50
  70.4%
98
  68.5%
148
  69.2%
1.Primary Outcome
Title Progression-free Survival
Hide Description Progression-free survival (PFS) was defined as the time from randomization to documented disease progression (at least a 20% increase in the sum of the longest diameter of target lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions) or death on study (death from any cause occurring no later than 30 days after last dose of any study treatment), whichever occurred first, as determined by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST). Median PFS was estimated using the Kaplan−Meier method.
Time Frame From randomization up to102 weeks. As of the clinical cut-off date (April 2009), the maximum time on treatment was 88 weeks, median time was 12.4 weeks for the Placebo arm and 16.1 weeks for the bevacizumab arm.
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Hide Analysis Population Description
Intent-to-treat (randomized) population. For patients without documentation of disease progression or death on study, PFS was censored at the time of the last tumor assessment.
Arm/Group Title Carboplatin+Paclitaxel+Placebo Carboplatin+Paclitaxel+Bevacizumab
Hide Arm/Group Description:
Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
Overall Number of Participants Analyzed 71 143
Median (95% Confidence Interval)
Unit of Measure: months
4.2
(2.83 to 5.36)
5.6
(4.21 to 6.80)
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival was defined as the time from randomization to death from any cause. Median OS was estimated using the Kaplan−Meier method. For patients without documentation of death, overall survival will be censored at the time of the last known contact.
Time Frame Up to 102 weeks
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Hide Analysis Population Description
Intent-to-treat (randomized) population
Arm/Group Title Carboplatin+Paclitaxel+Placebo Carboplatin+Paclitaxel+Bevacizumab
Hide Arm/Group Description:
Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
Overall Number of Participants Analyzed 71 143
Median (95% Confidence Interval)
Unit of Measure: months
8.6
(7.66 to 11.83)
12.3 [1] 
(10.35 to NA)
[1]
Upper limit of confidence interval not estimable due to very small number of deaths occurring after median was reached.
3.Secondary Outcome
Title Number of Participants With Objective Response
Hide Description Objective response was assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) criteria and was inclusive of complete and partial response determined on two consecutive investigator assessments conducted ≥ 4 weeks apart.
Time Frame Up to 102 weeks
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Hide Analysis Population Description
Intent-to-treat (randomized) population.
Arm/Group Title Carboplatin+Paclitaxel+Placebo Carboplatin+Paclitaxel+Bevacizumab
Hide Arm/Group Description:
Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
Overall Number of Participants Analyzed 67 141
Measure Type: Number
Unit of Measure: participants
11 36
4.Secondary Outcome
Title Percentage of Participants With an Objective Response
Hide Description

Objective response was defined as a complete or partial response according to RECIST criteria as assessed by the investigator on two consecutive assessments conducted at least 4 weeks apart.

The 95% Confidence Interval (CI) was calculated using the normal approximation to the binomial distribution.

Time Frame Up to 102 weeks
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Hide Analysis Population Description
Randomized Patients with Measurable Disease at Baseline
Arm/Group Title Carboplatin+Paclitaxel+Placebo Carboplatin+Paclitaxel+Bevacizumab
Hide Arm/Group Description:
Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
Overall Number of Participants Analyzed 67 141
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
16.4
(7.5 to 25.3)
25.5
(18.3 to 32.7)
5.Secondary Outcome
Title Duration of Objective Response
Hide Description Duration of objective response was defined as the time from the initial objective response to documented disease progression or death, whichever occurred first, assessed by the investigator using RECIST. Progressive disease was defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started, or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Duration of response was estimated using the Kaplan-Meier method.
Time Frame Up to 102 weeks
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Hide Analysis Population Description
Intent-to-treat (randomized) population. Only patients with measurable disease who achieved a response (either partial or complete) were included in the analysis of duration of response
Arm/Group Title Carboplatin+Paclitaxel+Placebo Carboplatin+Paclitaxel+Bevacizumab
Hide Arm/Group Description:
Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
Overall Number of Participants Analyzed 11 36
Median (95% Confidence Interval)
Unit of Measure: months
7.7
(3.94 to 11.56)
6.9
(4.86 to 8.90)
6.Secondary Outcome
Title Six-month Landmark Survival Rate
Hide Description Six-month Landmark Survival Rate was defined as the percentage of participants surviving at 6 months following randomization. Overall Survival was estimated using the Kaplan−Meier method.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (randomized) population
Arm/Group Title Carboplatin+Paclitaxel+Placebo Carboplatin+Paclitaxel+Bevacizumab
Hide Arm/Group Description:
Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
Overall Number of Participants Analyzed 71 143
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
74.6
(64.5 to 84.8)
78.2
(71.4 to 85.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Carboplatin+Paclitaxel+Placebo, Carboplatin+Paclitaxel+Bevacizumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5724
Comments [Not Specified]
Method z-test
Comments z-test using the standard errors computed using Greenwood's method.
Method of Estimation Estimation Parameter Difference in survival rates
Estimated Value 3.5
Confidence Interval 95%
-8.7 to 15.7
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Twenty−Four Week Landmark Stable Disease
Hide Description

As assessed by the investigator using RECIST and defined as the absence of disease progression for 24 weeks from the time of randomization.

The percentage of patients who did not experience disease progression or death at 24 weeks following randomization was estimated using Kaplan-Meier methodology. If no tumor assessments were performed after the baseline visit, the patient will be censored at the date of randomization plus 1 day.

Time Frame 24 weeks
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Hide Analysis Population Description
Intent-to-treat (randomized) patients
Arm/Group Title Carboplatin+Paclitaxel+Placebo Carboplatin+Paclitaxel+Bevacizumab
Hide Arm/Group Description:
Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
Overall Number of Participants Analyzed 71 143
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
38.0
(26.4 to 49.6)
50.2
(41.6 to 58.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Carboplatin+Paclitaxel+Placebo, Carboplatin+Paclitaxel+Bevacizumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0982
Comments [Not Specified]
Method z-test
Comments z-test using the standard errors computed using Greenwood's method
Method of Estimation Estimation Parameter Difference in event rates
Estimated Value 12.2
Confidence Interval 95%
-2.3 to 26.6
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Number of Participants With Select Adverse Events
Hide Description

Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. Select adverse events included arterial thromboembolic events (any grade), bleeding other than pulmonary or central nervous system (CNS) bleeding (Grade >= 3), CNS bleeding (any grade), febrile neutropenia (any grade), hypertension (Grade >= 3), neutropenia (Grade >= 3), pulmonary bleeding (any grade) and wound dehiscence (Grade >= 3).

*All serious adverse events are listed in the Adverse Event Reporting section.

Time Frame Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination.
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Hide Analysis Population Description
The Safety-evaluable population consisted of all patients who received at least one full or partial dose of any component of study treatment.
Arm/Group Title Carboplatin+Paclitaxel+Placebo Carboplatin+Paclitaxel+Bevacizumab
Hide Arm/Group Description:
Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
Overall Number of Participants Analyzed 69 143
Measure Type: Number
Unit of Measure: participants
Arterial thromboembolic events (any grade) 1 4
Bleeding other than pulmonary or CNS (Grade >=3) 4 0
CNS bleeding (any grade) 0 1
Febrile neutropenia (any grade) 1 7
Hypertension (Grade >= 3) 0 5
Neutropenia (Grade >= 3) 13 34
Pulmonary bleeding (any grade) 1 2
Wound dehiscence (Grade >= 3) 0 2
Time Frame Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination
Adverse Event Reporting Description

Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment

Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.

 
Arm/Group Title Carboplatin+Paclitaxel+Placebo Carboplatin+Paclitaxel+Bevacizumab
Hide Arm/Group Description Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo. Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
All-Cause Mortality
Carboplatin+Paclitaxel+Placebo Carboplatin+Paclitaxel+Bevacizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Carboplatin+Paclitaxel+Placebo Carboplatin+Paclitaxel+Bevacizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   20/69 (28.99%)   40/143 (27.97%) 
Blood and lymphatic system disorders     
Febrile Neutropenia  1  1/69 (1.45%)  5/143 (3.50%) 
Leukopenia  1  0/69 (0.00%)  1/143 (0.70%) 
Neutropenia  1  3/69 (4.35%)  6/143 (4.20%) 
Pancytopenia  1  0/69 (0.00%)  1/143 (0.70%) 
Cardiac disorders     
Acute Coronary Syndrome  1  0/69 (0.00%)  1/143 (0.70%) 
Atrial Fibrillation  1  1/69 (1.45%)  1/143 (0.70%) 
Myocardial Infarction  1  1/69 (1.45%)  1/143 (0.70%) 
Gastrointestinal disorders     
Abdominal Pain  1  0/69 (0.00%)  1/143 (0.70%) 
Diarrhea  1  1/69 (1.45%)  0/143 (0.00%) 
Dysphagia  1  0/69 (0.00%)  1/143 (0.70%) 
Gastrointestinal Hemorrhage  1  1/69 (1.45%)  0/143 (0.00%) 
Hematochezia  1  0/69 (0.00%)  1/143 (0.70%) 
Ileus  1  0/69 (0.00%)  1/143 (0.70%) 
Large Intestinal Hemorrhage  1  1/69 (1.45%)  0/143 (0.00%) 
Nausea  1  1/69 (1.45%)  0/143 (0.00%) 
Small Intestinal Hemorrhage  1  1/69 (1.45%)  1/143 (0.70%) 
Vomiting  1  1/69 (1.45%)  2/143 (1.40%) 
General disorders     
Asthenia  1  1/69 (1.45%)  0/143 (0.00%) 
Chest Pain  1  1/69 (1.45%)  0/143 (0.00%) 
Infusion Related Reaction  1  1/69 (1.45%)  0/143 (0.00%) 
Edema Peripheral  1  1/69 (1.45%)  0/143 (0.00%) 
Pyrexia  1  3/69 (4.35%)  2/143 (1.40%) 
Sudden Death  1  0/69 (0.00%)  1/143 (0.70%) 
Immune system disorders     
Anaphylactic Reaction  1  0/69 (0.00%)  1/143 (0.70%) 
Drug Hypersensitivity  1  1/69 (1.45%)  0/143 (0.00%) 
Infections and infestations     
Abdominal Abscess  1  0/69 (0.00%)  1/143 (0.70%) 
Cellulitis  1  1/69 (1.45%)  1/143 (0.70%) 
Gastroenteritis Viral  1  1/69 (1.45%)  0/143 (0.00%) 
Infected Sebaceous Cyst  1  0/69 (0.00%)  1/143 (0.70%) 
Pneumonia  1  1/69 (1.45%)  2/143 (1.40%) 
Sepsis  1  1/69 (1.45%)  1/143 (0.70%) 
Wound Infection  1  0/69 (0.00%)  1/143 (0.70%) 
Metabolism and nutrition disorders     
Dehydration  1  0/69 (0.00%)  2/143 (1.40%) 
Failure to Thrive  1  0/69 (0.00%)  1/143 (0.70%) 
Hypercalcemia  1  1/69 (1.45%)  1/143 (0.70%) 
Hypoglycemia  1  1/69 (1.45%)  0/143 (0.00%) 
Hypomagnesemia  1  1/69 (1.45%)  0/143 (0.00%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal Pain  1  0/69 (0.00%)  1/143 (0.70%) 
Pain in Extremity  1  0/69 (0.00%)  1/143 (0.70%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant Melanoma  1  0/69 (0.00%)  3/143 (2.10%) 
Malignant Pleural Effusion  1  0/69 (0.00%)  1/143 (0.70%) 
Tumor Hemorrhage  1  1/69 (1.45%)  0/143 (0.00%) 
Nervous system disorders     
Cerebellar Hemorrhage  1  0/69 (0.00%)  1/143 (0.70%) 
Cerebral Infarction  1  0/69 (0.00%)  1/143 (0.70%) 
Cerebrovascular Accident  1  0/69 (0.00%)  1/143 (0.70%) 
Convulsion  1  0/69 (0.00%)  1/143 (0.70%) 
Embolic Stroke  1  1/69 (1.45%)  0/143 (0.00%) 
Neuropathy Peripheral  1  0/69 (0.00%)  1/143 (0.70%) 
Renal and urinary disorders     
Calculus Ureteric  1  0/69 (0.00%)  1/143 (0.70%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  1/69 (1.45%)  3/143 (2.10%) 
Pulmonary Embolism  1  0/69 (0.00%)  5/143 (3.50%) 
Skin and subcutaneous tissue disorders     
Photosensitivity Reaction  1  1/69 (1.45%)  0/143 (0.00%) 
Vascular disorders     
Hypertension  1  0/69 (0.00%)  1/143 (0.70%) 
Hypotension  1  0/69 (0.00%)  1/143 (0.70%) 
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%
Carboplatin+Paclitaxel+Placebo Carboplatin+Paclitaxel+Bevacizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   69/69 (100.00%)   141/143 (98.60%) 
Blood and lymphatic system disorders     
Anaemia  1  17/69 (24.64%)  23/143 (16.08%) 
Leukopenia  1  8/69 (11.59%)  17/143 (11.89%) 
Neutropenia  1  15/69 (21.74%)  39/143 (27.27%) 
Thrombocytopenia  1  8/69 (11.59%)  19/143 (13.29%) 
Eye disorders     
Vision Blurred  1  3/69 (4.35%)  9/143 (6.29%) 
Visual Impairment  1  4/69 (5.80%)  5/143 (3.50%) 
Gastrointestinal disorders     
Abdominal Pain  1  5/69 (7.25%)  10/143 (6.99%) 
Abdominal Pain Upper  1  1/69 (1.45%)  8/143 (5.59%) 
Constipation  1  18/69 (26.09%)  57/143 (39.86%) 
Diarrhoea  1  23/69 (33.33%)  43/143 (30.07%) 
Dry Mouth  1  4/69 (5.80%)  7/143 (4.90%) 
Dyspepsia  1  4/69 (5.80%)  13/143 (9.09%) 
Nausea  1  33/69 (47.83%)  73/143 (51.05%) 
Stomatitis  1  2/69 (2.90%)  8/143 (5.59%) 
Vomiting  1  18/69 (26.09%)  33/143 (23.08%) 
General disorders     
Chills  1  4/69 (5.80%)  10/143 (6.99%) 
Fatigue  1  51/69 (73.91%)  102/143 (71.33%) 
Mucosal Inflammation  1  0/69 (0.00%)  11/143 (7.69%) 
Oedema Peripheral  1  8/69 (11.59%)  7/143 (4.90%) 
Pain  1  7/69 (10.14%)  18/143 (12.59%) 
Immune system disorders     
Hypersensitivity  1  4/69 (5.80%)  7/143 (4.90%) 
Infections and infestations     
Sinusitis  1  1/69 (1.45%)  10/143 (6.99%) 
Investigations     
Weight Decreased  1  1/69 (1.45%)  11/143 (7.69%) 
Metabolism and nutrition disorders     
Anorexia  1  21/69 (30.43%)  35/143 (24.48%) 
Decreased Appetite  1  2/69 (2.90%)  8/143 (5.59%) 
Dehydration  1  6/69 (8.70%)  2/143 (1.40%) 
Hyperglycaemia  1  3/69 (4.35%)  11/143 (7.69%) 
Hypokalaemia  1  4/69 (5.80%)  4/143 (2.80%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  17/69 (24.64%)  36/143 (25.17%) 
Back Pain  1  5/69 (7.25%)  20/143 (13.99%) 
Muscular Weakness  1  4/69 (5.80%)  6/143 (4.20%) 
Musculoskeletal Pain  1  4/69 (5.80%)  8/143 (5.59%) 
Myalgia  1  19/69 (27.54%)  30/143 (20.98%) 
Pain In Extremity  1  9/69 (13.04%)  11/143 (7.69%) 
Nervous system disorders     
Dizziness  1  6/69 (8.70%)  20/143 (13.99%) 
Dysgeusia  1  10/69 (14.49%)  16/143 (11.19%) 
Headache  1  8/69 (11.59%)  31/143 (21.68%) 
Neuropathy Peripheral  1  22/69 (31.88%)  51/143 (35.66%) 
Paraesthesia  1  5/69 (7.25%)  11/143 (7.69%) 
Peripheral Sensory Neuropathy  1  8/69 (11.59%)  19/143 (13.29%) 
Psychiatric disorders     
Anxiety  1  4/69 (5.80%)  9/143 (6.29%) 
Depression  1  4/69 (5.80%)  10/143 (6.99%) 
Insomnia  1  5/69 (7.25%)  14/143 (9.79%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  17/69 (24.64%)  24/143 (16.78%) 
Dysphonia  1  1/69 (1.45%)  10/143 (6.99%) 
Dyspnoea  1  8/69 (11.59%)  28/143 (19.58%) 
Epistaxis  1  4/69 (5.80%)  57/143 (39.86%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  42/69 (60.87%)  84/143 (58.74%) 
Hyperhidrosis  1  4/69 (5.80%)  0/143 (0.00%) 
Night Sweats  1  5/69 (7.25%)  5/143 (3.50%) 
Pruritus  1  6/69 (8.70%)  12/143 (8.39%) 
Rash  1  14/69 (20.29%)  16/143 (11.19%) 
Vascular disorders     
Flushing  1  2/69 (2.90%)  11/143 (7.69%) 
Hypertension  1  10/69 (14.49%)  32/143 (22.38%) 
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: NCT00434252     History of Changes
Other Study ID Numbers: AVF4096g
First Submitted: February 11, 2007
First Posted: February 13, 2007
Results First Submitted: March 29, 2011
Results First Posted: September 28, 2011
Last Update Posted: July 18, 2017