A Study Evaluating the Efficacy and Safety of Vismodegib (GDC-0449) in Operable Basal Cell Carcinoma
A Phase II, Multicenter, Open-label, Three-cohort Trial Evaluating the Efficacy and Safety of Vismodegib (GDC-0449) in Operable Basal Cell Carcinoma (BCC)
2 other identifiers
interventional
74
1 country
12
Brief Summary
This was a 3-cohort, open-label study of vismodegib (GDC-0449) in new (non-recurrent) operable basal cell carcinoma of the nodular subtype.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2010
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2010
CompletedFirst Posted
Study publicly available on registry
September 15, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedResults Posted
Study results publicly available
June 24, 2014
CompletedJune 24, 2014
May 1, 2014
2.6 years
September 10, 2010
May 22, 2014
May 22, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Complete Histologic Clearance
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.
Baseline to Week 12 (Cohort 1), Baseline to Week 36 (Cohort 2), Baseline to Week 20 (Cohort 3)
Secondary Outcomes (1)
Time to Complete Clinical Clearance
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)
Study Arms (3)
Cohort 1: Vismodegib 150 mg
EXPERIMENTALParticipants received vismodegib 150 mg orally daily for 12 weeks.
Cohort 2: Vismodegib 150 mg
EXPERIMENTALParticipants received vismodegib 150 mg orally daily for 12 weeks.
Cohort 3: Vismodegib 150 mg
EXPERIMENTALParticipants 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.
Interventions
Vismodegib was supplied in gelatin capsules.
Eligibility Criteria
You may qualify if:
- Confirmed new (not recurrent or previously treated) nodular basal cell carcinoma (BCC) at 1 of the listed anatomical sites, which must be biopsy confirmed at the study site.
- Willingness to consent to biopsy of the lesion.
- Willingness to delay excision of the target tumor site until the time mandated in the protocol, unless evidence of disease progression or lack of drug tolerability.
- Adequate hematopoietic capacity.
- Adequate hepatic function.
- For women of childbearing potential, agreement to use 2 acceptable forms of birth control (including one barrier method) during the study and for 7 months after discontinuation of study drug.
- For men with female partners of childbearing potential, agreement to use a male condom (with spermicide) and to advise their female partners to use an additional acceptable method of birth control during the study and for 2 months after discontinuation of study drug.
- Agreement not to donate blood/blood products during the study and for 7 months after discontinuing study drug.
- Agreement not to donate sperm or semen during treatment and for 2 months after the last dose of vismodegib.
You may not qualify if:
- Prior treatment with vismodegib or any Hedgehog pathway inhibitor.
- Inability or unwillingness to swallow capsules.
- Pregnancy or lactation.
- BCC with any clinical and histological pattern other than nodular BCC.
- Patients with known Gorlin's syndrome (basal cell nevus syndrome) or clinical suspicion of Gorlin's syndrome.
- Recent (ie, within the past 28 days), current, or planned participation in another experimental drug study.
- Use of any excluded medication or therapy within 21 days of study entry.
- History of other malignancies within 3 years of the first day of treatment (Day 1), except for tumors with a negligible risk of metastasis, such as other non-melanoma skin cancer (BCC, squamous cell cancer), ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix.
- Uncontrolled medical illness.
- History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or renders the patient at high risk for treatment complications.
- Any medical or psychological illness or condition preventing adequate consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (12)
Unknown Facility
Scottsdale, Arizona, 85259, United States
Unknown Facility
Los Angeles, California, 90045, United States
Unknown Facility
Redwood City, California, 94063, United States
Unknown Facility
San Diego, California, 92117, United States
Unknown Facility
St. Petersburg, Florida, 33716, United States
Unknown Facility
Alpharetta, Georgia, 30005, United States
Unknown Facility
Chicago, Illinois, 60611, United States
Unknown Facility
Louisville, Kentucky, 40217, United States
Unknown Facility
Philadelphia, Pennsylvania, 19111, United States
Unknown Facility
Bartlett, Tennessee, 38134, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
Madison, Wisconsin, 53705, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Genentech, Inc.
Study Officials
- STUDY DIRECTOR
Ivor Caro, M.D.
Genentech, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2010
First Posted
September 15, 2010
Study Start
October 1, 2010
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
June 24, 2014
Results First Posted
June 24, 2014
Record last verified: 2014-05