Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

COMPLETED

NCT00833417

PHASE2

A Study Evaluating the Efficacy and Safety of Vismodegib (GDC-0449, Hedgehog Pathway Inhibitor) in Patients With Advanced Basal Cell Carcinoma

Sponsor: Genentech, Inc.

View on ClinicalTrials.gov

Summary

This is a Phase II, single-arm, two-cohort multicenter clinical trial evaluating the efficacy and safety of vismodegib (GDC-0449) in patients with advanced basal cell carcinoma. All patients receive vismodegib until evidence of progression, intolerable toxicities most probably attributable to vismodegib, or withdrawal from the study.

Official title: A Pivotal Phase II, Multicenter, Single-arm, Two-cohort Trial Evaluating the Efficacy and Safety of GDC-0449 in Patients With Advanced Basal Cell Carcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

104

Start Date

2009-02-10

Completion Date

2014-04-09

Last Updated

2026-05-11

Healthy Volunteers

Conditions

Basal Cell Carcinoma

Interventions

DRUG

Vismodegib 150 mg

Vismodegib 150 mg was provided in hard gelatin capsules.

Inclusion Criteria: * Men and women ≥ 18 years of age. * For patients with metastatic basal cell carcinoma (BCC), histological confirmation of distant BCC metastasis (eg, lung, liver, lymph nodes, or bone), with metastatic disease that is Response Evaluation Criteria in Solid Tumors (RECIST) measurable using computed tomography (CT) or magnetic resonance imaging (MRI). * For patients with locally advanced BCC, histologically confirmed disease that is considered to be inoperable. * For patients with locally advanced BCC, radiotherapy must have been previously administered for their locally advanced BCC, unless radiotherapy is contraindicated or inappropriate. For patients whose locally advanced BCC has been irradiated, disease must have progressed after radiation. * 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. Exclusion Criteria: * Prior treatment with vismodegib or other Hedgehog pathway inhibitors. * Pregnancy or lactation. * Life expectancy of \< 12 weeks. * Patients with superficial multifocal BCC who may be considered unresectable due to breadth of involvement. * Concurrent non-protocol-specified anti-tumor therapy (eg, chemotherapy, other targeted therapy, radiation therapy, or photodynamic therapy). * Recent, current, or planned participation in an experimental drug study. * History of other malignancies within 3 years of the first day of treatment with vismodegib in this study (Day 1), except for tumors with a negligible risk for metastasis or death, such as adequately treated squamous-cell carcinoma of the skin, ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix. * Uncontrolled medical illnesses such as infection requiring treatment with intravenous antibiotics.

Locations (36)

Mayo Clinic

Scottsdale, Arizona, United States

Angeles Clinic & Rsch Inst

Los Angeles, California, United States

Stanford University Medical Center

Palo Alto, California, United States

Univ of Calif-San Francisco

San Francisco, California, United States

Univ of Colorado Hlth Sci Ctr

Aurora, Colorado, United States

Advanced Derm & Cosmetic Surg

Ormond Beach, Florida, United States

Northwestern University

Chicago, Illinois, United States

Siouxland Hematology/Oncology

Sioux City, Iowa, United States

Johns Hopkins Univ Med Center

Baltimore, Maryland, United States

Massachusetts General Hospital.

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Mayo Clinic Rochester; Medical Oncology

Rochester, Minnesota, United States

VA Southern Nevada Healthcare

Las Vegas, Nevada, United States

Dartmouth Hitchcock Med Center

Lebanon, New Hampshire, United States

Mount Sinai School of Medicine; Dermatology

New York, New York, United States

Univ No Carolina School of Med; Physicians Office Bldg

Chapel Hill, North Carolina, United States

Arthur G. James Cancer Hosp

Columbus, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

The Sarah Cannon Research Inst

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

St George Hospital

Kogarah, New South Wales, Australia

Princess AleXandra Hospital; Department of Medical Oncology

Woolloongabba, Queensland, Australia

Peter Maccallum Cancer Centre

Melbourne, Victoria, Australia

Institut Jules Bordet

Anderlecht, Belgium

Sint Augustinus Wilrijk, Apotheek

Wilrijk, Belgium

Hopital Claude Huriez

Lille, France

Hopital Hotel Dieu Et Hme; Clinique Dermatologique

Nantes, France

Hopital Saint Louis; Dermatologie 1

Paris, France

Centre Hospitalier Lyon Sud; Dermatologie

Pierre-Bénite, France

Universitätsklinik Essen; Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie

Essen, Germany

Universitätsklinikum Schleswig

Kiel, Germany

Universitaets-Hautklinik Tuebingen

Tübingen, Germany

Universitatsklinikum Wurzburg; Derma

Würzburg, Germany

Royal Marsden Hospital - London

London, United Kingdom

Poole Hospital; Dorset Cancer Centre

Poole, United Kingdom