Overview

This trial is active, not recruiting.

Condition basal cell carcinoma
Treatment vismodegib 150 mg
Phase phase 2
Sponsor Genentech
Start date February 2009
End date November 2010
Trial size 104 participants
Trial identifier NCT00833417, GO01541, SHH4476g

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 will receive vismodegib until evidence of progression, intolerable toxicities most probably attributable to vismodegib, or withdrawal from the study.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
vismodegib 150 mg GDC-0449
Vismodegib 150 mg was provided in hard gelatin capsules.

Primary Outcomes

Measure
Objective Response (OR) Determined by the Independent Review Facility
time frame: From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks

Secondary Outcomes

Measure
Duration of Objective Response (OR) Determined by the Independent Review Facility
time frame: From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks
Progression-free Survival (PFS) Determined by the Independent Review Facility
time frame: From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks
Overall Survival
time frame: From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks
Change From Baseline in Short Form 36 (SF-36) Health Survey Scores
time frame: Baseline, Week 12, Week 24, and at the end of the study or early termination visit, up to 90 weeks
Number of Patients With Absence of Residual Basal Cell Carcinoma BCC in Patients With Locally Advanced BCC
time frame: From baseline through end of the study, up to 90 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Phase II, Multicenter, Single-Arm, Two-Cohort Trial Evaluating the Efficacy and Safety of Vismodegib (GDC-0449) in Patients With Advanced Basal Cell Carcinoma
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Genentech.