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Trial record 17 of 78 for:    vismodegib

A Study Evaluating the Efficacy and Safety of Vismodegib (GDC-0449) in Operable Basal Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT01201915
Recruitment Status : Completed
First Posted : September 15, 2010
Results First Posted : June 24, 2014
Last Update Posted : June 24, 2014
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Basal Cell Carcinoma
Intervention Drug: Vismodegib
Enrollment 74
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cohort 1: Vismodegib 150 mg Cohort 2: Vismodegib 150 mg Cohort 3: Vismodegib 150 mg
Hide Arm/Group Description Participants received vismodegib 150 mg orally daily for 12 weeks. Participants received vismodegib 150 mg orally daily for 12 weeks. Participants received vismodegib 150 mg orally daily for 8 weeks, followed by 4 weeks with no treatment, followed by a second 8-week vismodegib treatment period.
Period Title: Overall Study
Started 24 25 25
Completed 16 14 19
Not Completed 8 11 6
Reason Not Completed
Adverse Event             2             1             1
Lost to Follow-up             0             4             0
Physician Decision             3             0             0
Subject Decision             3             3             5
Target Lesion Progression             0             3             0
Arm/Group Title Cohort 1: Vismodegib 150 mg Cohort 2: Vismodegib 150 mg Cohort 3: Vismodegib 150 mg Total
Hide Arm/Group Description Participants received vismodegib 150 mg orally daily for 12 weeks. Participants received vismodegib 150 mg orally daily for 12 weeks. Participants received vismodegib 150 mg orally daily for 8 weeks, followed by 4 weeks with no treatment, followed by a second 8-week vismodegib treatment period. Total of all reporting groups
Overall Number of Baseline Participants 24 25 25 74
Hide Baseline Analysis Population Description
Treated participants population: All study participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 25 participants 25 participants 74 participants
60.5  (11.2) 65.2  (13.3) 65.1  (11.8) 63.6  (12.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 25 participants 25 participants 74 participants
Female
5
  20.8%
3
  12.0%
8
  32.0%
16
  21.6%
Male
19
  79.2%
22
  88.0%
17
  68.0%
58
  78.4%
1.Primary Outcome
Title Percentage of Participants With Complete Histologic Clearance
Hide Description Complete histologic clearance was defined as the absence of histological evidence of basal cell carcinoma at the target tumor site. Histological examination was performed by an independent pathologist on specimens collected within 2 weeks of the end of treatment period, ie, at 12 weeks after Baseline in Cohort 1, at 36 weeks after Baseline in Cohort 2, and at 20 weeks after Baseline in Cohort 3.
Time Frame Baseline to Week 12 (Cohort 1), Baseline to Week 36 (Cohort 2), Baseline to Week 20 (Cohort 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy evaluable population: All participants who were treated with at least 1 dose of study drug.
Arm/Group Title Cohort 1: Vismodegib 150 mg Cohort 2: Vismodegib 150 mg Cohort 3: Vismodegib 150 mg
Hide Arm/Group Description:
Participants received vismodegib 150 mg orally daily for 12 weeks.
Participants received vismodegib 150 mg orally daily for 12 weeks.
Participants received vismodegib 150 mg orally daily for 8 weeks, followed by 4 weeks with no treatment, followed by a second 8-week vismodegib treatment period.
Overall Number of Participants Analyzed 24 25 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
42.0
(22.1 to 63.4)
16.0
(4.5 to 36.1)
44.0
(24.4 to 65.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 1: Vismodegib 150 mg
Comments The null hypothesis was that percentage of participants with complete histologic clearance was 50% or less.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8463
Comments [Not Specified]
Method 1-sided exact binomial test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort 2: Vismodegib 150 mg
Comments The null hypothesis was that percentage of participants with complete histologic clearance was 30% or less.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9668
Comments [Not Specified]
Method 1-sided exact binomial test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cohort 3: Vismodegib 150 mg
Comments The null hypothesis was that percentage of participants with complete histologic clearance was 50% or less.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7878
Comments [Not Specified]
Method 1-sided exact binomial test
Comments [Not Specified]
2.Secondary Outcome
Title Time to Complete Clinical Clearance
Hide Description Time to complete clinical clearance was defined as the time from the first treatment with vismodegib until complete clinical clearance as determined by the investigator.
Time Frame Baseline to the end of the study (up to 12 weeks for Cohort 1; up to 36 weeks for Cohort 2, up to 20 weeks for Cohort 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy evaluable population: All participants who were treated with at least 1 dose of study drug. Only participants who achieved complete clinical clearance were included in the analysis.
Arm/Group Title Cohort 1: Vismodegib 150 mg Cohort 2: Vismodegib 150 mg Cohort 3: Vismodegib 150 mg
Hide Arm/Group Description:
Participants received vismodegib 150 mg orally daily for 12 weeks.
Participants received vismodegib 150 mg orally daily for 12 weeks.
Participants received vismodegib 150 mg orally daily for 8 weeks, followed by 4 weeks with no treatment, followed by a second 8-week vismodegib treatment period.
Overall Number of Participants Analyzed 10 9 18
Median (95% Confidence Interval)
Unit of Measure: Days
59.5
(28.0 to 80.0)
84.0
(27.0 to 120.0)
60.0
(55.0 to 86.0)
Time Frame [Not Specified]
Adverse Event Reporting Description Safety population: All participants who were treated with at least 1 dose of study drug.
 
Arm/Group Title Cohort 1: Vismodegib 150 mg Cohort 2: Vismodegib 150 mg Cohort 3: Vismodegib 150 mg
Hide Arm/Group Description Participants received vismodegib 150 mg orally daily for 12 weeks. Participants received vismodegib 150 mg orally daily for 12 weeks. Participants received vismodegib 150 mg orally daily for 8 weeks, followed by 4 weeks with no treatment, followed by a second 8-week vismodegib treatment period.
All-Cause Mortality
Cohort 1: Vismodegib 150 mg Cohort 2: Vismodegib 150 mg Cohort 3: Vismodegib 150 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1: Vismodegib 150 mg Cohort 2: Vismodegib 150 mg Cohort 3: Vismodegib 150 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      3/25 (12.00%)      3/25 (12.00%)    
Cardiac disorders       
Atrial fibrillation  1  0/24 (0.00%)  0 0/25 (0.00%)  0 1/25 (4.00%)  1
Gastrointestinal disorders       
Small intestinal haemorrhage  1  0/24 (0.00%)  0 0/25 (0.00%)  1/25 (4.00%)  1
Haemorrhoidal haemorrhage  1  0/24 (0.00%)  0/25 (0.00%)  1/25 (4.00%) 
Hepatobiliary disorders       
Hepatitis  1  0/24 (0.00%)  0 0/25 (0.00%)  0 1/25 (4.00%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Bladder cancer  1  0/24 (0.00%)  0 1/25 (4.00%)  1 0/25 (0.00%)  0
Liposarcoma  1  0/24 (0.00%)  0 1/25 (4.00%)  1 0/25 (0.00%)  0
Nervous system disorders       
Ischaemic stroke  1  0/24 (0.00%)  0 1/25 (4.00%)  1 0/25 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort 1: Vismodegib 150 mg Cohort 2: Vismodegib 150 mg Cohort 3: Vismodegib 150 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/24 (100.00%)      25/25 (100.00%)      24/25 (96.00%)    
Ear and labyrinth disorders       
Vertigo  1  2/24 (8.33%)  0/25 (0.00%)  0/25 (0.00%) 
Gastrointestinal disorders       
Nausea  1  5/24 (20.83%)  2/25 (8.00%)  6/25 (24.00%) 
Constipation  1  0/24 (0.00%)  3/25 (12.00%)  3/25 (12.00%) 
Diarrhoea  1  2/24 (8.33%)  0/25 (0.00%)  3/25 (12.00%) 
Dyspepsia  1  2/24 (8.33%)  0/25 (0.00%)  2/25 (8.00%) 
Vomiting  1  0/24 (0.00%)  0/25 (0.00%)  3/25 (12.00%) 
General disorders       
Fatigue  1  5/24 (20.83%)  3/25 (12.00%)  7/25 (28.00%) 
Influenza Like Illness  1  0/24 (0.00%)  0/25 (0.00%)  2/25 (8.00%) 
Infections and infestations       
Upper Respiratory Tract Infection  1  0/24 (0.00%)  3/25 (12.00%)  0/25 (0.00%) 
Investigations       
Weight Decreased  1  0/24 (0.00%)  0/25 (0.00%)  3/25 (12.00%) 
Metabolism and nutrition disorders       
Decreased Appetite  1  3/24 (12.50%)  0/25 (0.00%)  4/25 (16.00%) 
Musculoskeletal and connective tissue disorders       
Muscle Spasms  1  19/24 (79.17%)  19/25 (76.00%)  18/25 (72.00%) 
Myalgia  1  0/24 (0.00%)  2/25 (8.00%)  2/25 (8.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Squamous Cell Carcinoma  1  0/24 (0.00%)  0/25 (0.00%)  2/25 (8.00%) 
Skin neoplasms malignant and unspecified (Excl melanoma)  1  0/24 (0.00%)  2/25 (8.00%)  0/25 (0.00%) 
Nervous system disorders       
Dysgeusia  1  9/24 (37.50%)  13/25 (52.00%)  15/25 (60.00%) 
Ageusia  1  10/24 (41.67%)  5/25 (20.00%)  7/25 (28.00%) 
Hypogeusia  1  2/24 (8.33%)  0/25 (0.00%)  0/25 (0.00%) 
Reproductive system and breast disorders       
Amenorrhoea  1  0/24 (0.00%)  2/25 (8.00%)  0/25 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  0/24 (0.00%)  0/25 (0.00%)  3/25 (12.00%) 
Nasal Congestion  1  0/24 (0.00%)  0/25 (0.00%)  2/25 (8.00%) 
Bronchitis  1  0/24 (0.00%)  2/25 (8.00%)  0/25 (0.00%) 
Skin and subcutaneous tissue disorders       
Alopecia  1  8/24 (33.33%)  17/25 (68.00%)  18/25 (72.00%) 
Madarosis  1  3/24 (12.50%)  2/25 (8.00%)  3/25 (12.00%) 
Hair Colour Changes  1  0/24 (0.00%)  2/25 (8.00%)  0/25 (0.00%) 
Actinic Keratosis  1  0/24 (0.00%)  2/25 (8.00%)  0/25 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
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: NCT01201915     History of Changes
Other Study ID Numbers: SHH4812g
GS01354 ( Other Identifier: Hoffmann-La Roche )
First Submitted: September 10, 2010
First Posted: September 15, 2010
Results First Submitted: May 22, 2014
Results First Posted: June 24, 2014
Last Update Posted: June 24, 2014