Overview

This trial is active, not recruiting.

Condition basal cell carcinoma
Treatments placebo, vismodegib
Phase phase 2
Targets hedgehog, SMO, PTCH1
Sponsor Hoffmann-La Roche
Start date April 2013
End date August 2016
Trial size 229 participants
Trial identifier NCT01815840, 2012-003305-10, MO28295

Summary

This randomized, double-blind, regimen-controlled, phase II, multicenter study will assess the efficacy and safety of two different vismodegib regimens in patients with multiple basal cell carcinoma. Patients 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
vismodegib
150 mg orally once daily, 72 weeks intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib
(Experimental)
placebo
orally daily, intermittent with vismodegib
vismodegib
150 mg orally once daily, 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib up to Week 72

Primary Outcomes

Measure
Relative reduction (%) from baseline in the number of clinically evident basal cell carcinomas at Week 73 (after 72 weeks of treatment)
time frame: from baseline to Week 73

Secondary Outcomes

Measure
Drop-out rate: Discontinuation of study treatment prior to Week 73 for either adverse events or withdrawal of consent by the patient
time frame: approximately 3.5 years
Relative reduction (%) from baseline in total size of three target basal cell carcinoma lesions in individual patients at Week 73
time frame: from baseline to Week 73
Proportion of patients with at least 50% reduction in the number of basal cell carcinomas at Week 73 in the two treatment regimens
time frame: approximately 3.5 years
Number of new basal cell carcinomas at Week 73 in the two treatment groups
time frame: approximately 3.5 years
Recurrence rate up to Week 125 (52 weeks after study drug discontinuation)
time frame: approximately 3.5 years
Safety: Incidence of adverse events
time frame: approximately 3.5 years
Patient reported outcomes: Skindex-16 tool
time frame: approximately 3.5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Adult patients, >/= 18 years of age - Patients with multiple basal cell carcinomas, including patients 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 7 months after completion of study treatment - Male patients 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

Additional Information

Official title A Randomized, Double-blinded, Regimen-controlled, Phase II, Multicenter Study to Assess the Efficacy and Safety of Two Different Vismodegib Regimens in Patients With Multiple Basal Cell Carcinomas
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.
Location data was received from the National Cancer Institute and was last updated in June 2016.