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

Phase 1

• Conditions: ocally advanced or metastatic basal cell carcinoma (BCC); MedDRA version: 14.1Level: PTClassification code 10004146Term: Basal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-000195-34-SI
• Lead Sponsor: F. Hoffmann-La Roche Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-03
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 501

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
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 330
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 220

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the safety of vismodegib (GDC-0449) in patients with locally advanced or metastatic BCC;Secondary Objective: - To assess the overall response rate (according to RECIST Version 1.1) in those patients with measurable disease as permitted by local regulatory requirement.<br>- To assess other efficacy parameters such as time to response, duration of response, progression-free survival and overall survival.<br>- To assess patient quality of life.;Primary end point(s): The primary objective of this trial is to assess the safety of vismodegib (GDC-0449) in patients with locally advanced or metastatic BCC.;Timepoint(s) of evaluation of this end point: Until disease progression or unacceptable toxicity (approximately 2 years)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Tumor response rate according to Response Evaluation Criteria in Solid Tumors (RECIST)<br>- Time to response<br>- Duration of response<br>- Progression-free survival<br>- Overall survival;Timepoint(s) of evaluation of this end point: Until disease progression or unacceptable toxicity (approximately 2 years)