A Study of Vismodegib With Surgery in Patients With Previously Untreated Basal Cell Carcinoma

Basal Cell Carcinoma Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Phase II Study To Assess The Efficacy And Safety Of Oral Vismodegib For The Treatment Of Basal Cell Carcinoma Preceding Excision By Mohs Micrographic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01898598
• Other study ID #: ML28726
• Status: Completed
• Phase: Phase 2
• First received: July 3, 2013
• Last updated: November 1, 2016
• Start date: February 2014
• Est. completion date: January 2016

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This randomized, double-blind, placebo-controlled study will assess the efficacy and safety of vismodegib with surgery in patients with basal cell carcinoma. Patients will be randomized to receive oral daily doses of vismodegib 150 mg or matching placebo. The anticipated time on study drug treatment is 12 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >=18 years of age

• Diagnosis of non-infected, not recurrent, previously untreated basal cell carcinoma

• Free of any significant physical abnormalities (e.g., tattoos) at the target basal cell carcinoma site

• Willing and able to participate in the study as an outpatient and agreement to make frequent visits to the clinic during the treatment and follow-up periods and to comply with study requirements

Exclusion Criteria:

• Prior treatment with vismodegib

• Known hypersensitivity to any of the study drug excipients

• Any metastatic basal cell carcinoma

• Any locally advanced basal cell carcinoma considered to be inoperable or to have a medical contraindication to surgery

• Evidence of clinically significant and unstable diseases or conditions (e.g., cardiovascular, immunosuppressive, hematologic)

• Any dermatological disease at the target basal cell carcinoma site that may cause difficulty with examination

• Recent, current, or planned participation in another experimental drug study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell

Intervention

Drug:
• Placebo
Matching placebo to vismodegib
• vismodegib
vismodegib 150 mg oral doses once a day for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in surgical defect area		From baseline to 12-14 weeks	No
Secondary	Complete response rate		From baseline to 12-14 weeks	No
Secondary	Partial response rate		From baseline to 12-14 weeks	No
Secondary	Actual change in expected surgical defect area		From baseline to 12-14 weeks	No
Secondary	Occurrence of unconnected residual tumor		From baseline to 12-14 weeks	No
Secondary	Percent change in actual tumor-free margin excision area		From baseline to 12-14 weeks	No
Secondary	Cumulative recurrence rate of the target basal cell carcinoma at Weeks 12, 24, and 52 post-surgery		Weeks 12, 24 and 52	No
Secondary	Safety: Incidence of adverse events		100 weeks	No