STEVIE: A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

• Status: Completed
• Trial end date: 2017-06-14
• Target enrollment: 0
• Participant gender: All

Summary

This single-arm, open-label, multi-center study will evaluate the safety and efficacy of vismodegib (GDC-0449) in patients with locally advanced or metastatic basal cell carcinoma. Patients will receive oral doses of vismodegib 150 mg once daily until disease progression or unacceptable toxicity.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

Inclusion Criteria:

• Adult patients, >/=18 years of age

• Metastatic or locally advanced basal cell carcinoma considered inoperable or that surgery is contraindicated and radiotherapy is contraindicated or inappropriate

• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2

Exclusion Criteria:

• Concurrent anti-tumor therapy

• Completion of the most recent anti-tumor therapy less than 21 days prior to the initiation of treatment

• Uncontrolled medical illness