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A Study to Evaluate rhuMab 2C4 and Gemcitabine in Subjects With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00096993
Recruitment Status : Completed
First Posted : November 18, 2004
Results First Posted : June 10, 2015
Last Update Posted : June 10, 2015
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
Conditions Ovarian Cancer
Peritoneal Cancer
Fallopian Tube Cancer
Interventions Drug: Placebo
Drug: Gemcitabine
Drug: Pertuzumab
Enrollment 131
Recruitment Details  
Pre-assignment Details One subject in the placebo + gemcitabine arm did not receive any study treatment as the subject died of a cerebrovascular accident prior to the first scheduled dose. This subject was excluded from both the efficacy and safety analyses, per protocol.
Arm/Group Title Placebo + Gemcitabine Pertuzumab + Gemcitabine
Hide Arm/Group Description

Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).

Placebo: Placebo was provided as a single-use formulation for infusion.

Gemcitabine: Gemcitabine was provided as a solution for infusion.

Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles

Gemcitabine: Gemcitabine was provided as a solution for infusion.

Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion.

Period Title: Overall Study
Started 66 65
Completed 1 0
Not Completed 65 65
Reason Not Completed
Death             1             0
Disease progression             56             53
Adverse Event             2             8
Subject's decision             3             1
Physician Decision             2             1
Non-compliance             0             1
Other unspecified             1             1
Arm/Group Title Placebo + Gemcitabine Pertuzumab + Gemcitabine Total
Hide Arm/Group Description

Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).

Placebo: Placebo was provided as a single-use formulation for infusion.

Gemcitabine: Gemcitabine was provided as a solution for infusion.

Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles

Gemcitabine: Gemcitabine was provided as a solution for infusion.

Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion.

Total of all reporting groups
Overall Number of Baseline Participants 65 65 130
Hide Baseline Analysis Population Description
Safety population: All participants who received any amount of study treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 65 participants 65 participants 130 participants
59.7  (11.94) 57.8  (10.79) 58.7  (11.38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 65 participants 130 participants
Female
65
 100.0%
65
 100.0%
130
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Progression-free Survival
Hide Description Progression-free survival was defined as the time from the first day of treatment (Cycle 1, Day 1) to the time of documented disease progression or death, whichever occurred first. Disease progression was assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR) was defined as disappearance of all target lesions; Partial Response (PR) was defined as >=30% decrease in the sum of the longest diameter of target lesions and Overall Response (OR) = CR + PR.
Time Frame Baseline to the end of the study (up to 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy-evaluable population: All randomized participants who received at least 1 dose of study medication.
Arm/Group Title Placebo + Gemcitabine Pertuzumab + Gemcitabine
Hide Arm/Group Description:

Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).

Placebo: Placebo was provided as a single-use formulation for infusion.

Gemcitabine: Gemcitabine was provided as a solution for infusion.

Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles

Gemcitabine: Gemcitabine was provided as a solution for infusion.

Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion.

Overall Number of Participants Analyzed 54 49
Median (95% Confidence Interval)
Unit of Measure: months
2.6
(1.4 to 3.9)
2.9
(2.6 to 4.4)
2.Secondary Outcome
Title Percentage of Participants With an Objective Response
Hide Description An objective response was defined as a complete or partial response determined on two consecutive occasions ≥ 4 weeks apart. Responses were determined by Response Evaluation Criteria in Solid Tumors (RECIST). A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter of target lesions.
Time Frame Baseline to the end of the study (up to 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy-evaluable population: All randomized participants who received at least 1 dose of study medication.
Arm/Group Title Placebo + Gemcitabine Pertuzumab + Gemcitabine
Hide Arm/Group Description:

Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).

Placebo: Placebo was provided as a single-use formulation for infusion.

Gemcitabine: Gemcitabine was provided as a solution for infusion.

Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles

Gemcitabine: Gemcitabine was provided as a solution for infusion.

Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion.

Overall Number of Participants Analyzed 65 65
Measure Type: Number
Unit of Measure: percentage of participants
4.6 13.8
3.Secondary Outcome
Title Duration of the Objective Response
Hide Description Duration of the objective response was defined as the time from the initial response to disease progression or death from any cause.
Time Frame Baseline to the end of the study (up to 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy-evaluable population: All randomized participants who received at least 1 dose of study medication. Only participants with an objective response were included in the analysis.
Arm/Group Title Placebo + Gemcitabine Pertuzumab + Gemcitabine
Hide Arm/Group Description:

Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).

Placebo: Placebo was provided as a single-use formulation for infusion.

Gemcitabine: Gemcitabine was provided as a solution for infusion.

Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles

Gemcitabine: Gemcitabine was provided as a solution for infusion.

Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion.

Overall Number of Participants Analyzed 3 9
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(4.1 to NA)
6.9
(4.1 to 7.4)
[1]
Value is not estimable; not reached
4.Secondary Outcome
Title Percentage of Participants Free From Disease Progression at 4 Months
Hide Description Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
Time Frame Baseline to Month 4
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy-evaluable population: All randomized participants who received at least 1 dose of study medication.
Arm/Group Title Placebo + Gemcitabine Pertuzumab + Gemcitabine
Hide Arm/Group Description:

Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).

Placebo: Placebo was provided as a single-use formulation for infusion.

Gemcitabine: Gemcitabine was provided as a solution for infusion.

Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles

Gemcitabine: Gemcitabine was provided as a solution for infusion.

Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion.

Overall Number of Participants Analyzed 65 65
Measure Type: Number
Unit of Measure: percentage of participants
37.3 47.6
5.Secondary Outcome
Title Duration of Survival
Hide Description Duration of survival was defined as the time from randomization until death from any cause.
Time Frame Baseline to the end of the study (up to 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy-evaluable population: All randomized participants who received at least 1 dose of study medication.
Arm/Group Title Placebo + Gemcitabine Pertuzumab + Gemcitabine
Hide Arm/Group Description:

Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).

Placebo: Placebo was provided as a single-use formulation for infusion.

Gemcitabine: Gemcitabine was provided as a solution for infusion.

Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles

Gemcitabine: Gemcitabine was provided as a solution for infusion.

Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion.

Overall Number of Participants Analyzed 65 65
Median (95% Confidence Interval)
Unit of Measure: months
13.1
(10.5 to 15.5)
13.0
(9.6 to 18.5)
Time Frame All adverse events were collected from the beginning of study treatment until 30 days after discontinuation of study treatment.
Adverse Event Reporting Description Safety population: All participants who received any amount of study treatment.
 
Arm/Group Title Placebo + Gemcitabine Pertuzumab + Gemcitabine
Hide Arm/Group Description

Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).

Placebo: Placebo was provided as a single-use formulation for infusion.

Gemcitabine: Gemcitabine was provided as a solution for infusion.

Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles

Gemcitabine: Gemcitabine was provided as a solution for infusion.

Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion.

All-Cause Mortality
Placebo + Gemcitabine Pertuzumab + Gemcitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo + Gemcitabine Pertuzumab + Gemcitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   40/65 (61.54%)   23/65 (35.38%) 
Blood and lymphatic system disorders     
FEBRILE NEUTROPENIA  1  2/65 (3.08%)  0/65 (0.00%) 
THROMBOCYTOPENIA  1  0/65 (0.00%)  2/65 (3.08%) 
ANAEMIA  1  0/65 (0.00%)  1/65 (1.54%) 
HAEMOLYTIC URAEMIC SYNDROME  1  0/65 (0.00%)  1/65 (1.54%) 
Cardiac disorders     
CARDIAC FAILURE CONGESTIVE  1  0/65 (0.00%)  1/65 (1.54%) 
Gastrointestinal disorders     
SMALL INTESTINAL OBSTRUCTION  1  8/65 (12.31%)  2/65 (3.08%) 
VOMITING  1  3/65 (4.62%)  1/65 (1.54%) 
ILEUS  1  2/65 (3.08%)  1/65 (1.54%) 
INTESTINAL OBSTRUCTION  1  3/65 (4.62%)  0/65 (0.00%) 
ABDOMINAL PAIN  1  0/65 (0.00%)  2/65 (3.08%) 
NAUSEA  1  2/65 (3.08%)  0/65 (0.00%) 
COLONIC STENOSIS  1  1/65 (1.54%)  0/65 (0.00%) 
CONSTIPATION  1  1/65 (1.54%)  0/65 (0.00%) 
UPPER GASTROINTESTINAL HAEMORRHAGE  1  1/65 (1.54%)  0/65 (0.00%) 
General disorders     
CHEST PAIN  1  1/65 (1.54%)  1/65 (1.54%) 
CATHETER RELATED COMPLICATION  1  0/65 (0.00%)  1/65 (1.54%) 
FATIGUE  1  1/65 (1.54%)  0/65 (0.00%) 
INFUSION RELATED REACTION  1  1/65 (1.54%)  0/65 (0.00%) 
PYREXIA  1  1/65 (1.54%)  0/65 (0.00%) 
Hepatobiliary disorders     
CHOLECYSTITIS  1  0/65 (0.00%)  1/65 (1.54%) 
Immune system disorders     
ANAPHYLACTIC REACTION  1  0/65 (0.00%)  1/65 (1.54%) 
HYPERSENSITIVITY  1  0/65 (0.00%)  1/65 (1.54%) 
Infections and infestations     
PNEUMONIA  1  2/65 (3.08%)  1/65 (1.54%) 
CELLULITIS  1  1/65 (1.54%)  1/65 (1.54%) 
INFECTION  1  2/65 (3.08%)  0/65 (0.00%) 
CATHETER RELATED INFECTION  1  0/65 (0.00%)  1/65 (1.54%) 
CLOSTRIDIAL INFECTION  1  1/65 (1.54%)  0/65 (0.00%) 
CLOSTRIDIUM DIFFICILE COLITIS  1  0/65 (0.00%)  1/65 (1.54%) 
SEPSIS  1  1/65 (1.54%)  0/65 (0.00%) 
STAPHYLOCOCCAL INFECTION  1  0/65 (0.00%)  1/65 (1.54%) 
URINARY TRACT INFECTION  1  1/65 (1.54%)  0/65 (0.00%) 
Injury, poisoning and procedural complications     
FEEDING TUBE COMPLICATION  1  1/65 (1.54%)  0/65 (0.00%) 
Metabolism and nutrition disorders     
DEHYDRATION  1  3/65 (4.62%)  1/65 (1.54%) 
HYPONATRAEMIA  1  1/65 (1.54%)  0/65 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
MALIGNANT MELANOMA  1  1/65 (1.54%)  0/65 (0.00%) 
Nervous system disorders     
DIZZINESS  1  0/65 (0.00%)  1/65 (1.54%) 
Psychiatric disorders     
CONFUSIONAL STATE  1  1/65 (1.54%)  1/65 (1.54%) 
MENTAL STATUS CHANGES  1  0/65 (0.00%)  1/65 (1.54%) 
Renal and urinary disorders     
RENAL FAILURE ACUTE  1  3/65 (4.62%)  1/65 (1.54%) 
HAEMATURIA  1  1/65 (1.54%)  0/65 (0.00%) 
URETERIC OBSTRUCTION  1  1/65 (1.54%)  0/65 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
PLEURAL EFFUSION  1  1/65 (1.54%)  4/65 (6.15%) 
DYSPNOEA  1  2/65 (3.08%)  2/65 (3.08%) 
PULMONARY EMBOLISM  1  2/65 (3.08%)  0/65 (0.00%) 
PNEUMONIA ASPIRATION  1  1/65 (1.54%)  0/65 (0.00%) 
PNEUMONITIS  1  0/65 (0.00%)  1/65 (1.54%) 
PNEUMOTHORAX  1  0/65 (0.00%)  1/65 (1.54%) 
PULMONARY FIBROSIS  1  1/65 (1.54%)  0/65 (0.00%) 
PULMONARY OEDEMA  1  0/65 (0.00%)  1/65 (1.54%) 
RESPIRATORY ARREST  1  1/65 (1.54%)  0/65 (0.00%) 
RESPIRATORY FAILURE  1  1/65 (1.54%)  0/65 (0.00%) 
Skin and subcutaneous tissue disorders     
DERMATOMYOSITIS  1  1/65 (1.54%)  0/65 (0.00%) 
Vascular disorders     
DEEP VEIN THROMBOSIS  1  2/65 (3.08%)  2/65 (3.08%) 
HYPOTENSION  1  2/65 (3.08%)  0/65 (0.00%) 
HYPERTENSION  1  0/65 (0.00%)  1/65 (1.54%) 
THROMBOSIS  1  1/65 (1.54%)  0/65 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo + Gemcitabine Pertuzumab + Gemcitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   65/65 (100.00%)   65/65 (100.00%) 
Blood and lymphatic system disorders     
ANAEMIA  1  39/65 (60.00%)  31/65 (47.69%) 
NEUTROPENIA  1  29/65 (44.62%)  32/65 (49.23%) 
THROMBOCYTOPENIA  1  16/65 (24.62%)  19/65 (29.23%) 
LEUKOPENIA  1  8/65 (12.31%)  9/65 (13.85%) 
Cardiac disorders     
LEFT VENTRICULAR DYSFUNCTION  1  3/65 (4.62%)  5/65 (7.69%) 
TACHYCARDIA  1  4/65 (6.15%)  3/65 (4.62%) 
Eye disorders     
VISION BLURRED  1  3/65 (4.62%)  5/65 (7.69%) 
Gastrointestinal disorders     
NAUSEA  1  47/65 (72.31%)  49/65 (75.38%) 
DIARRHOEA  1  39/65 (60.00%)  44/65 (67.69%) 
VOMITING  1  33/65 (50.77%)  32/65 (49.23%) 
CONSTIPATION  1  40/65 (61.54%)  13/65 (20.00%) 
ABDOMINAL PAIN  1  26/65 (40.00%)  22/65 (33.85%) 
ABDOMINAL DISTENSION  1  21/65 (32.31%)  12/65 (18.46%) 
STOMATITIS  1  11/65 (16.92%)  19/65 (29.23%) 
DYSPEPSIA  1  13/65 (20.00%)  14/65 (21.54%) 
ABDOMINAL PAIN UPPER  1  13/65 (20.00%)  6/65 (9.23%) 
GASTROOESOPHAGEAL REFLUX DISEASE  1  10/65 (15.38%)  9/65 (13.85%) 
ABDOMINAL DISCOMFORT  1  8/65 (12.31%)  5/65 (7.69%) 
ABDOMINAL PAIN LOWER  1  5/65 (7.69%)  7/65 (10.77%) 
ASCITES  1  9/65 (13.85%)  3/65 (4.62%) 
DRY MOUTH  1  5/65 (7.69%)  2/65 (3.08%) 
FLATULENCE  1  3/65 (4.62%)  4/65 (6.15%) 
ORAL PAIN  1  4/65 (6.15%)  2/65 (3.08%) 
RECTAL HAEMORRHAGE  1  2/65 (3.08%)  4/65 (6.15%) 
General disorders     
FATIGUE  1  50/65 (76.92%)  51/65 (78.46%) 
OEDEMA PERIPHERAL  1  28/65 (43.08%)  20/65 (30.77%) 
PYREXIA  1  22/65 (33.85%)  19/65 (29.23%) 
CHILLS  1  12/65 (18.46%)  12/65 (18.46%) 
PAIN  1  12/65 (18.46%)  12/65 (18.46%) 
ASTHENIA  1  11/65 (16.92%)  7/65 (10.77%) 
CHEST PAIN  1  7/65 (10.77%)  6/65 (9.23%) 
MUCOSAL INFLAMMATION  1  5/65 (7.69%)  7/65 (10.77%) 
OEDEMA  1  1/65 (1.54%)  6/65 (9.23%) 
INJECTION SITE PAIN  1  5/65 (7.69%)  1/65 (1.54%) 
INJECTION SITE IRRITATION  1  5/65 (7.69%)  0/65 (0.00%) 
Immune system disorders     
HYPERSENSITIVITY  1  1/65 (1.54%)  4/65 (6.15%) 
Infections and infestations     
URINARY TRACT INFECTION  1  16/65 (24.62%)  12/65 (18.46%) 
UPPER RESPIRATORY TRACT INFECTION  1  5/65 (7.69%)  4/65 (6.15%) 
CELLULITIS  1  5/65 (7.69%)  1/65 (1.54%) 
SINUSITIS  1  0/65 (0.00%)  4/65 (6.15%) 
Injury, poisoning and procedural complications     
CONTUSION  1  4/65 (6.15%)  3/65 (4.62%) 
Investigations     
ALANINE AMINOTRANSFERASE INCREASED  1  22/65 (33.85%)  22/65 (33.85%) 
ASPARTATE AMINOTRANSFERASE INCREASED  1  23/65 (35.38%)  21/65 (32.31%) 
HAEMOGLOBIN DECREASED  1  10/65 (15.38%)  11/65 (16.92%) 
BLOOD LACTATE DEHYDROGENASE INCREASED  1  7/65 (10.77%)  8/65 (12.31%) 
BLOOD CREATININE INCREASED  1  7/65 (10.77%)  5/65 (7.69%) 
BLOOD ALKALINE PHOSPHATASE INCREASED  1  5/65 (7.69%)  6/65 (9.23%) 
EJECTION FRACTION DECREASED  1  7/65 (10.77%)  4/65 (6.15%) 
NEUTROPHIL COUNT DECREASED  1  7/65 (10.77%)  3/65 (4.62%) 
BLOOD ALBUMIN DECREASED  1  5/65 (7.69%)  4/65 (6.15%) 
WHITE BLOOD CELL COUNT DECREASED  1  6/65 (9.23%)  3/65 (4.62%) 
PLATELET COUNT DECREASED  1  7/65 (10.77%)  1/65 (1.54%) 
WEIGHT DECREASED  1  4/65 (6.15%)  4/65 (6.15%) 
BLOOD GLUCOSE INCREASED  1  1/65 (1.54%)  4/65 (6.15%) 
BLOOD URINE PRESENT  1  4/65 (6.15%)  1/65 (1.54%) 
Metabolism and nutrition disorders     
ANOREXIA  1  21/65 (32.31%)  18/65 (27.69%) 
HYPOKALAEMIA  1  20/65 (30.77%)  12/65 (18.46%) 
DECREASED APPETITE  1  15/65 (23.08%)  7/65 (10.77%) 
DEHYDRATION  1  14/65 (21.54%)  6/65 (9.23%) 
HYPERGLYCAEMIA  1  13/65 (20.00%)  7/65 (10.77%) 
HYPOCALCAEMIA  1  15/65 (23.08%)  5/65 (7.69%) 
HYPOALBUMINAEMIA  1  15/65 (23.08%)  3/65 (4.62%) 
HYPOMAGNESAEMIA  1  15/65 (23.08%)  1/65 (1.54%) 
HYPONATRAEMIA  1  5/65 (7.69%)  4/65 (6.15%) 
Musculoskeletal and connective tissue disorders     
BACK PAIN  1  18/65 (27.69%)  27/65 (41.54%) 
PAIN IN EXTREMITY  1  19/65 (29.23%)  12/65 (18.46%) 
ARTHRALGIA  1  15/65 (23.08%)  9/65 (13.85%) 
MYALGIA  1  10/65 (15.38%)  4/65 (6.15%) 
MUSCULOSKELETAL PAIN  1  8/65 (12.31%)  5/65 (7.69%) 
FLANK PAIN  1  6/65 (9.23%)  6/65 (9.23%) 
NECK PAIN  1  6/65 (9.23%)  3/65 (4.62%) 
MUSCLE SPASMS  1  3/65 (4.62%)  5/65 (7.69%) 
BONE PAIN  1  5/65 (7.69%)  2/65 (3.08%) 
MUSCULAR WEAKNESS  1  3/65 (4.62%)  4/65 (6.15%) 
MUSCULOSKELETAL CHEST PAIN  1  4/65 (6.15%)  3/65 (4.62%) 
Nervous system disorders     
HEADACHE  1  19/65 (29.23%)  24/65 (36.92%) 
DYSGEUSIA  1  9/65 (13.85%)  7/65 (10.77%) 
DIZZINESS  1  5/65 (7.69%)  5/65 (7.69%) 
NEUROPATHY  1  3/65 (4.62%)  5/65 (7.69%) 
NEUROPATHY PERIPHERAL  1  3/65 (4.62%)  4/65 (6.15%) 
HYPOAESTHESIA  1  4/65 (6.15%)  2/65 (3.08%) 
Psychiatric disorders     
INSOMNIA  1  16/65 (24.62%)  11/65 (16.92%) 
ANXIETY  1  12/65 (18.46%)  7/65 (10.77%) 
DEPRESSION  1  10/65 (15.38%)  7/65 (10.77%) 
Renal and urinary disorders     
DYSURIA  1  13/65 (20.00%)  6/65 (9.23%) 
MICTURITION URGENCY  1  4/65 (6.15%)  3/65 (4.62%) 
POLLAKIURIA  1  6/65 (9.23%)  1/65 (1.54%) 
HYDRONEPHROSIS  1  4/65 (6.15%)  2/65 (3.08%) 
HAEMATURIA  1  5/65 (7.69%)  0/65 (0.00%) 
NOCTURIA  1  0/65 (0.00%)  4/65 (6.15%) 
Reproductive system and breast disorders     
VULVOVAGINAL DRYNESS  1  3/65 (4.62%)  5/65 (7.69%) 
Respiratory, thoracic and mediastinal disorders     
DYSPNOEA  1  20/65 (30.77%)  19/65 (29.23%) 
COUGH  1  19/65 (29.23%)  19/65 (29.23%) 
EPISTAXIS  1  3/65 (4.62%)  15/65 (23.08%) 
RHINORRHOEA  1  5/65 (7.69%)  10/65 (15.38%) 
PHARYNGOLARYNGEAL PAIN  1  6/65 (9.23%)  8/65 (12.31%) 
Skin and subcutaneous tissue disorders     
RASH  1  17/65 (26.15%)  26/65 (40.00%) 
PRURITUS  1  9/65 (13.85%)  12/65 (18.46%) 
HYPERHIDROSIS  1  6/65 (9.23%)  5/65 (7.69%) 
ERYTHEMA  1  5/65 (7.69%)  5/65 (7.69%) 
ALOPECIA  1  4/65 (6.15%)  5/65 (7.69%) 
DRY SKIN  1  1/65 (1.54%)  5/65 (7.69%) 
ACNE  1  1/65 (1.54%)  4/65 (6.15%) 
Vascular disorders     
FLUSHING  1  7/65 (10.77%)  3/65 (4.62%) 
HOT FLUSH  1  6/65 (9.23%)  2/65 (3.08%) 
HYPOTENSION  1  5/65 (7.69%)  3/65 (4.62%) 
DEEP VEIN THROMBOSIS  1  4/65 (6.15%)  1/65 (1.54%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Genentech, Inc.
Phone: 800 821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00096993     History of Changes
Other Study ID Numbers: TOC3258g
First Submitted: November 17, 2004
First Posted: November 18, 2004
Results First Submitted: May 26, 2015
Results First Posted: June 10, 2015
Last Update Posted: June 10, 2015