A Study of Two Vismodegib Regimens in Participants With Multiple Basal Cell Carcinomas

Roche

Status and phase: Completed; Phase 2

Conditions: Basal Cell Carcinoma

Treatments: Drug: Placebo; Drug: Vismodegib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01815840

2012-003305-10 (EudraCT Number)

MO28295

Details and patient eligibility

About

This randomized, double-blind, regimen-controlled, phase II, multicenter study will assess the efficacy and safety of two different vismodegib regimens in participants with multiple basal cell carcinoma. Participants will receive vismodegib 150 mg orally once daily either in an intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo (Arm A) or as 24 weeks induction followed by an intermittent schedule of 8 weeks placebo followed by 8 weeks vismodegib (Arm B). Anticipated time on study treatment is 72 weeks.

Enrollment: 229 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult participants, >/= 18 years of age
• Participants with multiple basal cell carcinomas, including participants with Gorlin syndrome, with at least 6 clinically evident basal cell carcinomas at the time of randomization, of which 3 measure 5 mm or more in diameter and are considered target lesions. All other lesions are considered to be non-target lesions
• Histopathologic confirmation that at least one of the three target lesions is basal cell carcinoma
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
• Adequate renal and hepatic function and hematopoietic capacity
• Women of childbearing potential must agree to use contraception as defined by protocol during treatment and for at least 9 months after completion of study treatment
• Male participants with female partners of childbearing potential must agree to use contraception as defined by protocol during treatment and for 2 months after completion of study treatment

Exclusion criteria

• Inability or unwillingness to swallow capsules
• Pregnant or breastfeeding women
• Any metastatic basal cell carcinoma
• Locally advanced basal cell carcinoma lesion that is considered to be inoperable or to have medical contraindications to surgery
• Recent (i.e., within the past 28 days prior to randomization) or current participation in another experimental drug study
• Known or suspected alcohol abuse
• One of the following known rare hereditary conditions: galactose intolerance, primary hypolactasia or glucose-galactose malabsorption

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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229 participants in 2 patient groups

Vismodegib Intermittent Schedule

Experimental group

Description:

Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up

Treatment:

Drug: Vismodegib

Drug: Placebo

Vismodegib Induction Followed by Intermittent Schedule

Experimental group

Description:

Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up

Treatment:

Drug: Vismodegib

Drug: Placebo