A Study Evaluating the Efficacy and Safety of Vismodegib (GDC-0449) in Operable Basal Cell Carcinoma

Recruiting in Palo Alto (17 mi)

+11 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Genentech, Inc.

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This was a 3-cohort, open-label study of vismodegib (GDC-0449) in new (non-recurrent) operable basal cell carcinoma of the nodular subtype.

Research Team

Ivor Caro, M.D.

Principal Investigator

Genentech, Inc.

Eligibility Criteria

Inclusion Criteria

Confirmed new (not recurrent or previously treated) nodular basal cell carcinoma (BCC) at 1 of the listed anatomical sites, which must be biopsy confirmed at the study site.

Willingness to consent to biopsy of the lesion.

Willingness to delay excision of the target tumor site until the time mandated in the protocol, unless evidence of disease progression or lack of drug tolerability.

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Treatment Details

Interventions

Vismodegib (Hedgehog Pathway Inhibitor)

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Cohort 3: Vismodegib 150 mgExperimental Treatment1 Intervention

Participants received vismodegib 150 mg orally daily for 8 weeks, followed by 4 weeks with no treatment, followed by a second 8-week vismodegib treatment period.

Group II: Cohort 2: Vismodegib 150 mgExperimental Treatment1 Intervention

Participants received vismodegib 150 mg orally daily for 12 weeks.

Group III: Cohort 1: Vismodegib 150 mgExperimental Treatment1 Intervention

Participants received vismodegib 150 mg orally daily for 12 weeks.