A Study of Vismodegib (GDC-0449) in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

NCT ID: NCT01160250

Last Updated: 2015-08-06

Basic Information

• Recruitment Status: APPROVED_FOR_MARKETING
• Study Classification: EXPANDED_ACCESS
• Study Start Date: 2010-07-31
• Study Completion Date: 2012-04-30

Brief Summary

This is an open-label, non-comparative, multicenter, expanded access study of Vismodegib (GDC-0449) in patients with locally advanced basal cell carcinoma (BCC) or metastatic BCC (mBCC) who are otherwise without satisfactory treatment options.

Conditions

Basal Cell Carcinoma

Interventions

vismodegib (GDC-0449)

Oral repeating dose

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• For patients with mBCC, histologic confirmation of distant BCC metastasis
• For patients with locally advanced BCC, at least one histologically confirmed lesion 10 mm or more in diameter and written confirmation from a surgical specialist that the tumor is considered inoperable or that surgery is contraindicated
• For patients with locally advanced BCC, radiotherapy must have been previously administered for locally advanced BCC, unless radiotherapy is contraindicated or inappropriate. For patients whose locally advanced BCC has been irradiated, disease must have progressed after radiation.
• Patients with Gorlin syndrome may enroll in this study but must meet the criteria for locally advanced or metastatic disease listed above
• Patients with measurable and/or non-measurable disease (as defined by RECIST) are allowed
• Adequate organ function
• For women of childbearing potential, agreement to the use of two acceptable methods of contraception, including one barrier method, during the study and for 12 months after discontinuation of Vismodegib (GDC-0449)
• For men with female partners of childbearing potential, agreement to use a latex condom, and to advise their female partner to use an additional method of contraception during the study and for 3 months after discontinuation of Vismodegib (GDC-0449)

Exclusion Criteria

• Pregnancy or lactation
• Life expectancy < 12 weeks
• Concurrent non-protocol-specified anti-tumor therapy
• Completion of most recent anti-tumor therapy at least 21 days prior to initiation of treatment
• Uncontrolled medical illnesses such as infection requiring treatment with intravenous antibiotics
• History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or renders the patient at high risk from treatment complications
• Unwillingness to practice effective birth control

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Scottsdale, Arizona, United States

Scottsdale, Arizona, United States

Los Angeles, California, United States

Stanford, California, United States

Ormond Beach, Florida, United States

Detroit, Michigan, United States

New York, New York, United States

Columbus, Ohio, United States

Philadelphia, Pennsylvania, United States

Nashville, Tennessee, United States

Houston, Texas, United States

Countries

United States

References

Chang AL, Arron ST, Migden MR, Solomon JA, Yoo S, Day BM, McKenna EF, Sekulic A. Safety and efficacy of vismodegib in patients with basal cell carcinoma nevus syndrome: pooled analysis of two trials. Orphanet J Rare Dis. 2016 Sep 1;11(1):120. doi: 10.1186/s13023-016-0506-z.

Reference Type: DERIVED

PMID: 27581207 (View on PubMed)

Other Identifiers

SHH4811g

Identifier Type: -

Identifier Source: org_study_id