A single arm, open-label, phase II, multicentre study to assess the safety of vismodegib (GDC-0449) in patients with locally advanced or metastatic basal cell carcinoma (BCC).

Phase 2

Completed

Conditions: basal cell-carcinoma
cancer
10040900

Registration Number: NL-OMON39484

Lead Sponsor: Roche Nederland B.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

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;- Patients with one of the following rare hereditary conditions: galactose intolerance, primary hypolactasia, or glucose-galactose malabsorption

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- To assess the safety of vismodegib in patients with (inoperable) locally<br /><br>advanced or metastatic BCC.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To assess the overall response rate (ORR; according to RECIST, v1.1) in those<br /><br>patients with measurable disease, as permitted by local regulatory requirement.<br /><br>- To assess other efficacy parameters, such as time to response, duration of<br /><br>response, progression-free survival (PFS), and overall survival (OS).<br /><br>- To assess patient quality of life (QoL).<br /><br>- To assess the impact of vismodegib treatment on disease symptoms in patient<br /><br>with metastatic BCC who enrolled after apporval of the Study Protocol, version<br /><br>4.0, using the M.D. Anderson Symptom Inventory.<br /><br>- To assess the status of the Hedgehoc pathway and/or other modifiers of<br /><br>vismodegib activity in tumor tissue obtained from patients with metastatic BCC<br /><br>who have disease progression on vismodegib therapy. </p><br>