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

Roche

Status and phase: Completed; Phase 2

Conditions: Basal Cell Carcinoma

Treatments: Drug: vismodegib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01367665

MO25616

2011-000195-34 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 1,232 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,232 participants in 2 patient groups

Vismodegib - Locally Advanced

Experimental group

Description:

Participants received vismodegib 150 mg orally once a day until one of the following occurs: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator. vismodegib: 150 mg once daily until disease progression or unacceptable toxicity

Treatment:

Drug: vismodegib

Vismodegib - Metastatic

Experimental group

Description:

Participants received vismodegib 150 mg orally once a day until one of the following occurs: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator. vismodegib: 150 mg once daily until disease progression or unacceptable toxicity

Treatment:

Drug: vismodegib