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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01201915
First received: September 10, 2010
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

This is a three-cohort, open-label study of Vismodegib (GDC-0449) in new (non-recurrent) operable BCC of the nodular subtype.


Condition Intervention Phase
Basal Cell Carcinoma
Drug: vismodegib (GDC-0449)
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:

Primary Outcome Measures:
  • Cohort 1: Rate of complete histologic clearance (CHC) of target nodular BCC lesions at the time of Mohs excision [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Cohort 2: Rate of durable complete histologic clearance of target nodular BCC lesions at the time of Mohs excision [ Time Frame: Up to 36 weeks ] [ Designated as safety issue: No ]
  • Cohort 3: Rate of complete histologic clearance (CHC) of target nodular BCC lesions at the time of Mohs excision [ Time Frame: Up to 20 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to complete clinical clearance [ Time Frame: Time from first treatment to the time of Mohs excision at end of specified treatment period (up to 36 weeks) ] [ Designated as safety issue: No ]

Enrollment: 74
Study Start Date: August 2010
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 3 Drug: vismodegib (GDC-0449)
Oral vismodegib, 150mg per day for 8 weeks, 4-week drug break, 150mg per day for 8 weeks.
Experimental: Cohort 1 Drug: vismodegib (GDC-0449)
Oral vismodegib, 150mg per day for 12 weeks
Experimental: Cohort 2 Drug: vismodegib (GDC-0449)
Oral vismodegib, 150mg per day for 12 weeks, 24-week observation.

  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 BCC at one 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 two 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 (i.e., 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 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, 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
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
Investigators
Study Director: Ivor Caro, M.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01201915     History of Changes
Other Study ID Numbers: SHH4812g, GS01354
Study First Received: September 10, 2010
Last Updated: February 24, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 14, 2014