Trial Outcomes & Findings for A Study of Vismodegib (GDC-0449, Hedgehog Pathway Inhibitor) As Maintenance Therapy in Patients With Ovarian Cancer in a Second or Third Complete Remission (NCT NCT00739661)
NCT ID: NCT00739661
Last Updated: 2017-06-08
Results Overview
PFS was defined as the time between randomization and disease progression, as confirmed by radiography, or death for any reason. Since patients were in remission at the start of the study, they had no evidence of the presence of tumors. Disease progression was defined as radiographic evidence of a tumor. Tumor assessments by computed tomography (CT) of the chest, abdomen, and pelvis were performed at screening and every 8 weeks during the study.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
104 participants
Primary outcome timeframe
From randomization date through the data cut-off date of May 15, 2010, up to 100 weeks
Results posted on
2017-06-08
Participant Flow
Participant milestones
| Measure |
Vismodegib 150 mg
Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
|
Placebo to Vismodegib
Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
52
|
|
Overall Study
COMPLETED
|
6
|
10
|
|
Overall Study
NOT COMPLETED
|
46
|
42
|
Reasons for withdrawal
| Measure |
Vismodegib 150 mg
Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
|
Placebo to Vismodegib
Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Physician decision to withdraw patient
|
1
|
0
|
|
Overall Study
Patient decision to withdraw
|
9
|
4
|
|
Overall Study
Disease progression, radiographic
|
33
|
37
|
|
Overall Study
Reason for discontinuation not available
|
1
|
1
|
Baseline Characteristics
A Study of Vismodegib (GDC-0449, Hedgehog Pathway Inhibitor) As Maintenance Therapy in Patients With Ovarian Cancer in a Second or Third Complete Remission
Baseline characteristics by cohort
| Measure |
Vismodegib 150 mg
n=52 Participants
Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
|
Placebo to Vismodegib
n=52 Participants
Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.3 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
58.6 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
57.9 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization date through the data cut-off date of May 15, 2010, up to 100 weeksPopulation: Intent-to-treat patient population: All randomized patients.
PFS was defined as the time between randomization and disease progression, as confirmed by radiography, or death for any reason. Since patients were in remission at the start of the study, they had no evidence of the presence of tumors. Disease progression was defined as radiographic evidence of a tumor. Tumor assessments by computed tomography (CT) of the chest, abdomen, and pelvis were performed at screening and every 8 weeks during the study.
Outcome measures
| Measure |
Vismodegib 150 mg
n=52 Participants
Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
|
Placebo to Vismodegib
n=52 Participants
Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
|
|---|---|---|
|
Progression-free Survival (PFS)
|
7.5 Months
Interval 5.59 to 11.24
|
5.8 Months
Interval 4.14 to 7.49
|
SECONDARY outcome
Timeframe: From randomization date through the data cut-off date of May 15, 2010, up to 100 weeksPopulation: Intent-to-treat patient population: All randomized patients. Tissue for evaluation was only available for 29 patients in the vismodegib group and 28 patients in the placebo group.
Hedgehog antigen expression was measured with immunohistochemical methods in tumor tissue taken from each patient prior to enrollment in the study. The percentage of cells with (\> 0%) and without (0%) Hedgehog antigen expression was measured microscopically. PFS was defined as the time between randomization and disease progression, as confirmed by radiography, or death for any reason. Tumor assessments by computed tomography (CT) of the chest, abdomen, and pelvis were performed at screening and every 8 weeks during the study.
Outcome measures
| Measure |
Vismodegib 150 mg
n=29 Participants
Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
|
Placebo to Vismodegib
n=28 Participants
Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
|
|---|---|---|
|
Progression-free Survival (PFS) in Patients With Versus Without Hedgehog Antigen Tumor Expression
0% of cells with hedgehog punctate stain
|
7.00 Months
95% Confidence Interval 3.48 • Interval 3.48 to 8.05
|
5.32 Months
Interval 1.94 to
The upper limit of the confidence interval could not be estimated due to the small sample size.
|
|
Progression-free Survival (PFS) in Patients With Versus Without Hedgehog Antigen Tumor Expression
> 0% of cells with Hedgehog punctate stain
|
9.13 Months
Interval 1.81 to 11.24
|
7.36 Months
Interval 3.12 to 10.97
|
SECONDARY outcome
Timeframe: From randomization date through the data cut-off date of May 15, 2010, up to 100 weeksPopulation: Intent-to-treat patient population: All randomized patients.
Overall survival was defined as the time from randomization until death by any cause.
Outcome measures
| Measure |
Vismodegib 150 mg
n=52 Participants
Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
|
Placebo to Vismodegib
n=52 Participants
Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
|
|---|---|---|
|
Overall Survival
|
NA Months
Standard Deviation NA
The data were not mature for analysis. Only 2 deaths in the vismodegib group were reported as of the 15 May 2010 data cutoff.
|
NA Months
Standard Deviation NA
The data were not mature for analysis. Only 1 death in the placebo group was reported as of the 15 May 2010 data cutoff.
|
Adverse Events
Vismodegib 150 mg
Serious events: 6 serious events
Other events: 51 other events
Deaths: 0 deaths
Placebo to Vismodegib
Serious events: 3 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vismodegib 150 mg
n=52 participants at risk
Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
|
Placebo to Vismodegib
n=52 participants at risk
Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
|
|---|---|---|
|
Cardiac disorders
Cardiac Failure Congestive
|
1.9%
1/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
0.00%
0/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.9%
1/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
0.00%
0/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
1.9%
1/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
General disorders
Chest Pain
|
1.9%
1/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
0.00%
0/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Infections and infestations
Device Related Infection
|
0.00%
0/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
1.9%
1/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
1.9%
1/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Investigations
Hepatic Enzyme Increased
|
1.9%
1/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
0.00%
0/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma
|
1.9%
1/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
0.00%
0/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Renal Colic
|
1.9%
1/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
0.00%
0/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
1.9%
1/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
0.00%
0/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.9%
1/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
0.00%
0/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
Other adverse events
| Measure |
Vismodegib 150 mg
n=52 participants at risk
Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
|
Placebo to Vismodegib
n=52 participants at risk
Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
32.7%
17/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
17.3%
9/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
19.2%
10/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
13.5%
7/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
23.1%
12/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
9.6%
5/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.5%
6/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
15.4%
8/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
15.4%
8/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
9.6%
5/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
17.3%
9/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
5.8%
3/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
3.8%
2/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
7.7%
4/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal Distension
|
3.8%
2/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
7.7%
4/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dry Mouth
|
9.6%
5/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
1.9%
1/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
3.8%
2/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
7.7%
4/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.8%
3/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
3.8%
2/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
5.8%
3/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
1.9%
1/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
General disorders
Fatigue
|
26.9%
14/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
28.8%
15/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
General disorders
Asthenia
|
9.6%
5/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
5.8%
3/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Infections and infestations
Influenza
|
7.7%
4/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
5.8%
3/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Infections and infestations
Urinary Tract Infection
|
5.8%
3/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
0.00%
0/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Investigations
Weight Decreased
|
11.5%
6/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
1.9%
1/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
19.2%
10/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
1.9%
1/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.8%
3/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
1.9%
1/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
67.3%
35/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
1.9%
1/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.4%
8/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
15.4%
8/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
11.5%
6/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
7.7%
4/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
9.6%
5/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
5.8%
3/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
7.7%
4/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
3.8%
2/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.8%
3/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
3.8%
2/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Nervous system disorders
Dysgeusia
|
67.3%
35/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
17.3%
9/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Nervous system disorders
Headache
|
9.6%
5/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
11.5%
6/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
7.7%
4/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
9.6%
5/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Nervous system disorders
Neuropathy Peripheral
|
3.8%
2/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
7.7%
4/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Nervous system disorders
Paraesthesia
|
5.8%
3/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
5.8%
3/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Nervous system disorders
Ageusia
|
7.7%
4/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
1.9%
1/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
5.8%
3/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
5.8%
3/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Psychiatric disorders
Anxiety
|
5.8%
3/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
3.8%
2/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Psychiatric disorders
Depression
|
5.8%
3/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
0.00%
0/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.6%
5/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
9.6%
5/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
3.8%
2/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
5.8%
3/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
53.8%
28/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
7.7%
4/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.5%
6/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
3.8%
2/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.7%
4/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
5.8%
3/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Nail Disorder
|
0.00%
0/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
5.8%
3/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
|
Vascular disorders
Hypertension
|
3.8%
2/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
5.8%
3/52 • Adverse events and serious adverse events were recorded starting at randomization until 45 days after the last dose of treatment or after the initiation of new anti-tumor therapy, whichever was earlier, up to 100 weeks.
Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
|
Additional Information
Medical Communications
Genentech, Inc
Phone: 800-821-8590
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER