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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01201915
First received: September 10, 2010
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

This was a 3-cohort, open-label study of vismodegib (GDC-0449) in new (non-recurrent) operable basal cell carcinoma of the nodular subtype.


Condition Intervention Phase
Basal Cell Carcinoma
Drug: Vismodegib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Multicenter, Open-label, Three-cohort Trial Evaluating the Efficacy and Safety of Vismodegib (GDC-0449) in Operable Basal Cell Carcinoma (BCC)

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Percentage of Participants With Complete Histologic Clearance [ Time Frame: Baseline to Week 12 (Cohort 1), Baseline to Week 36 (Cohort 2), Baseline to Week 20 (Cohort 3) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Time to Complete Clinical Clearance [ 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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 74
Study Start Date: October 2010
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1: Vismodegib 150 mg
Participants received vismodegib 150 mg orally daily for 12 weeks.
Drug: Vismodegib
Vismodegib was supplied in gelatin capsules.
Other Name: GDC-0449
Experimental: Cohort 2: Vismodegib 150 mg
Participants received vismodegib 150 mg orally daily for 12 weeks.
Drug: Vismodegib
Vismodegib was supplied in gelatin capsules.
Other Name: GDC-0449
Experimental: Cohort 3: Vismodegib 150 mg
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.
Drug: Vismodegib
Vismodegib was supplied in gelatin capsules.
Other Name: GDC-0449

Detailed Description:

For Cohort 1, the response to treatment was determined at the end of the 12 weeks of treatment. For Cohort 2, the response to treatment was determined after 12 weeks of treatment and 24 weeks of observation. For Cohort 3, the response to treatment was determined after intermittent dosing over a 20-week period, consisting of an initial 8-week treatment period, followed by a 4-week drug holiday period, followed by a second 8-week treatment period.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01201915

Locations
United States, Arizona
Scottsdale, Arizona, United States, 85259
United States, California
Los Angeles, California, United States, 90045
Redwood City, California, United States, 94063
San Diego, California, United States, 92117
United States, Florida
St. Petersburg, Florida, United States, 33716
United States, Georgia
Alpharetta, Georgia, United States, 30005
United States, Illinois
Chicago, Illinois, United States, 60611
United States, Kentucky
Louisville, Kentucky, United States, 40217
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
Bartlett, Tennessee, United States, 38134
United States, Texas
Houston, Texas, United States, 77030
United States, Wisconsin
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Ivor Caro, M.D. Genentech, Inc.
  More Information

No publications provided

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01201915     History of Changes
Other Study ID Numbers: SHH4812g, GS01354
Study First Received: September 10, 2010
Results First Received: May 22, 2014
Last Updated: May 22, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Basal Cell
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 20, 2014