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Trial record 10 of 108 for:    hedgehog

A Study of Vismodegib (GDC-0449, Hedgehog Pathway Inhibitor) As Maintenance Therapy in Patients With Ovarian Cancer in a Second or Third Complete Remission

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ClinicalTrials.gov Identifier: NCT00739661
Recruitment Status : Completed
First Posted : August 22, 2008
Results First Posted : April 26, 2012
Last Update Posted : June 8, 2017
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Ovarian Cancer
Interventions Drug: Vismodegib 150 mg
Drug: Placebo to vismodegib
Enrollment 104

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vismodegib 150 mg Placebo to Vismodegib
Hide Arm/Group Description Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study. Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
Period Title: Overall Study
Started 52 52
Completed 6 10
Not Completed 46 42
Reason Not Completed
Adverse Event             2             0
Physician decision to withdraw patient             1             0
Patient decision to withdraw             9             4
Disease progression, radiographic             33             37
Reason for discontinuation not available             1             1
Arm/Group Title Vismodegib 150 mg Placebo to Vismodegib Total
Hide Arm/Group Description Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study. Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study. Total of all reporting groups
Overall Number of Baseline Participants 52 52 104
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 52 participants 52 participants 104 participants
57.3  (10.2) 58.6  (8.9) 57.9  (9.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 52 participants 104 participants
Female
52
 100.0%
52
 100.0%
104
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description 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.
Time Frame From randomization date through the data cut-off date of May 15, 2010, up to 100 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat patient population: All randomized patients.
Arm/Group Title Vismodegib 150 mg Placebo to Vismodegib
Hide Arm/Group Description:
Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
Overall Number of Participants Analyzed 52 52
Median (95% Confidence Interval)
Unit of Measure: Months
7.5
(5.59 to 11.24)
5.8
(4.14 to 7.49)
2.Secondary Outcome
Title Progression-free Survival (PFS) in Patients With Versus Without Hedgehog Antigen Tumor Expression
Hide Description 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.
Time Frame From randomization date through the data cut-off date of May 15, 2010, up to 100 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat patient population: All randomized patients. Tissue for evaluation was only available for 29 patients in the vismodegib group and 28 patients in the placebo group.
Arm/Group Title Vismodegib 150 mg Placebo to Vismodegib
Hide Arm/Group Description:
Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
Overall Number of Participants Analyzed 29 28
Median (95% Confidence Interval)
Unit of Measure: Months
0% of cells with hedgehog punctate stain
7.00
(3.48 to 8.05)
5.32 [1] 
(1.94 to NA)
> 0% of cells with Hedgehog punctate stain
9.13
(1.81 to 11.24)
7.36
(3.12 to 10.97)
[1]
The upper limit of the confidence interval could not be estimated due to the small sample size.
3.Secondary Outcome
Title Overall Survival
Hide Description Overall survival was defined as the time from randomization until death by any cause.
Time Frame From randomization date through the data cut-off date of May 15, 2010, up to 100 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat patient population: All randomized patients.
Arm/Group Title Vismodegib 150 mg Placebo to Vismodegib
Hide Arm/Group Description:
Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
Overall Number of Participants Analyzed 52 52
Mean (Standard Deviation)
Unit of Measure: Months
NA [1]   (NA) NA [2]   (NA)
[1]
The data were not mature for analysis. Only 2 deaths in the vismodegib group were reported as of the 15 May 2010 data cutoff.
[2]
The data were not mature for analysis. Only 1 death in the placebo group was reported as of the 15 May 2010 data cutoff.
Time Frame 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 Event Reporting Description Adverse events were reported for the safety-evaluable population, which was defined as all patients who received at least one dose of study treatment.
 
Arm/Group Title Vismodegib 150 mg Placebo to Vismodegib
Hide Arm/Group Description Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study. Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
All-Cause Mortality
Vismodegib 150 mg Placebo to Vismodegib
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vismodegib 150 mg Placebo to Vismodegib
Affected / at Risk (%) Affected / at Risk (%)
Total   6/52 (11.54%)   3/52 (5.77%) 
Cardiac disorders     
Cardiac Failure Congestive  1  1/52 (1.92%)  0/52 (0.00%) 
Gastrointestinal disorders     
Abdominal Pain  1  1/52 (1.92%)  0/52 (0.00%) 
Small Intestinal Obstruction  1  0/52 (0.00%)  1/52 (1.92%) 
General disorders     
Chest Pain  1  1/52 (1.92%)  0/52 (0.00%) 
Infections and infestations     
Device Related Infection  1  0/52 (0.00%)  1/52 (1.92%) 
Urinary Tract Infection  1  0/52 (0.00%)  1/52 (1.92%) 
Investigations     
Hepatic Enzyme Increased  1  1/52 (1.92%)  0/52 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung Adenocarcinoma  1  1/52 (1.92%)  0/52 (0.00%) 
Renal and urinary disorders     
Renal Colic  1  1/52 (1.92%)  0/52 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Emphysema  1  1/52 (1.92%)  0/52 (0.00%) 
Pneumothorax  1  1/52 (1.92%)  0/52 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vismodegib 150 mg Placebo to Vismodegib
Affected / at Risk (%) Affected / at Risk (%)
Total   51/52 (98.08%)   44/52 (84.62%) 
Gastrointestinal disorders     
Nausea  1  17/52 (32.69%)  9/52 (17.31%) 
Abdominal Pain  1  10/52 (19.23%)  7/52 (13.46%) 
Constipation  1  12/52 (23.08%)  5/52 (9.62%) 
Diarrhoea  1  6/52 (11.54%)  8/52 (15.38%) 
Vomiting  1  8/52 (15.38%)  5/52 (9.62%) 
Abdominal Pain Upper  1  9/52 (17.31%)  3/52 (5.77%) 
Abdominal Discomfort  1  2/52 (3.85%)  4/52 (7.69%) 
Abdominal Distension  1  2/52 (3.85%)  4/52 (7.69%) 
Dry Mouth  1  5/52 (9.62%)  1/52 (1.92%) 
Flatulence  1  2/52 (3.85%)  4/52 (7.69%) 
Dyspepsia  1  3/52 (5.77%)  2/52 (3.85%) 
Abdominal Pain Lower  1  3/52 (5.77%)  1/52 (1.92%) 
General disorders     
Fatigue  1  14/52 (26.92%)  15/52 (28.85%) 
Asthenia  1  5/52 (9.62%)  3/52 (5.77%) 
Infections and infestations     
Influenza  1  4/52 (7.69%)  3/52 (5.77%) 
Urinary Tract Infection  1  3/52 (5.77%)  0/52 (0.00%) 
Investigations     
Weight Decreased  1  6/52 (11.54%)  1/52 (1.92%) 
Metabolism and nutrition disorders     
Decreased Appetite  1  10/52 (19.23%)  1/52 (1.92%) 
Hypomagnesaemia  1  3/52 (5.77%)  1/52 (1.92%) 
Musculoskeletal and connective tissue disorders     
Muscle Spasms  1  35/52 (67.31%)  1/52 (1.92%) 
Arthralgia  1  8/52 (15.38%)  8/52 (15.38%) 
Back Pain  1  6/52 (11.54%)  4/52 (7.69%) 
Musculoskeletal Pain  1  5/52 (9.62%)  3/52 (5.77%) 
Pain In Extremity  1  4/52 (7.69%)  2/52 (3.85%) 
Myalgia  1  3/52 (5.77%)  2/52 (3.85%) 
Nervous system disorders     
Dysgeusia  1  35/52 (67.31%)  9/52 (17.31%) 
Headache  1  5/52 (9.62%)  6/52 (11.54%) 
Dizziness  1  4/52 (7.69%)  5/52 (9.62%) 
Neuropathy Peripheral  1  2/52 (3.85%)  4/52 (7.69%) 
Paraesthesia  1  3/52 (5.77%)  3/52 (5.77%) 
Ageusia  1  4/52 (7.69%)  1/52 (1.92%) 
Psychiatric disorders     
Insomnia  1  3/52 (5.77%)  3/52 (5.77%) 
Anxiety  1  3/52 (5.77%)  2/52 (3.85%) 
Depression  1  3/52 (5.77%)  0/52 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  5/52 (9.62%)  5/52 (9.62%) 
Oropharyngeal Pain  1  2/52 (3.85%)  3/52 (5.77%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  28/52 (53.85%)  4/52 (7.69%) 
Rash  1  6/52 (11.54%)  2/52 (3.85%) 
Pruritus  1  4/52 (7.69%)  3/52 (5.77%) 
Nail Disorder  1  0/52 (0.00%)  3/52 (5.77%) 
Vascular disorders     
Hypertension  1  2/52 (3.85%)  3/52 (5.77%) 
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: NCT00739661     History of Changes
Other Study ID Numbers: SHH4489g
First Submitted: August 21, 2008
First Posted: August 22, 2008
Results First Submitted: February 10, 2012
Results First Posted: April 26, 2012
Last Update Posted: June 8, 2017