Trial Outcomes & Findings for Vismodegib for Treatment of Basal Cell Carcinoma (NCT NCT01543581)

Results Overview

The final wound size taken immediately after the completion of Mohs surgery (i.e., upon reaching tumor-free tissue margins) was determined using pre treatment lesion outlined plus one additional concentric 2mm margin removed to establish an objective consistent measure for wound size. The diameter of the final wound size was measured in mm.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

The Mohs surgical excision of the target tumor was performed within two weeks, after the last day of treatment.

Results posted on

2014-09-26

Participant Flow

The dates of the recruitment period in this study were Dec. 12,2011 through November 2012. Prospective subjects were seen in Loma Linda University Dermatology Clinic and were also seen prior to being referred to Loma Linda at Riverside County Regional Medical Clinic.

One subject signed the consent and was enrolled and completed the study. Two others signed the consent but were unable to continue their enrollment as one found out that he had Parkinsons Disease and the other could not arrange for transportation.

Participant milestones

Participant milestones
Measure	Vismodegib Those to whom the drug is given.	Inactive Placebo Those to whom the inactive placebo is given.
Overall Study STARTED	1	0
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vismodegib for Treatment of Basal Cell Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vismodegib n=1 Participants Oral vismodegib, 150mg per day for 12 weeks.
Age, Categorical <=18 years	00 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	00 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: The Mohs surgical excision of the target tumor was performed within two weeks, after the last day of treatment.

The final wound size taken immediately after the completion of Mohs surgery (i.e., upon reaching tumor-free tissue margins) was determined using pre treatment lesion outlined plus one additional concentric 2mm margin removed to establish an objective consistent measure for wound size. The diameter of the final wound size was measured in mm.

Outcome measures

Outcome measures
Measure	Vismodegib n=1 Participants Oral vismodegib, 150mg per day for 12 weeks.
Mohs Micrographic Surgery (MMS)	1 mm

SECONDARY outcome

Timeframe: 12 to 14 weeks

A secondary variable is the complete response rate, defined as the proportion of patients with no histological evidence of basal cell carcinoma on the post treatment MMS excision of the target tumor area. For this analysis, the placebo data will be pooled together to calculate the complete response rate for the placebo group.

Outcome measures

Outcome measures
Measure	Vismodegib n=1 Participants Oral vismodegib, 150mg per day for 12 weeks.
Complete Response Rate	1 participants

Adverse Events

Vismodegib

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Inactive Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Vismodegib n=1 participants at risk Oral vismodegib, 150mg per day for 12 weeks.	Inactive Placebo Those to whom the inactive placebo is given.
Respiratory, thoracic and mediastinal disorders Chest Cold	100.0% 1/1 • Number of events 1 • 10 months	— 0/0 • 10 months
Blood and lymphatic system disorders Elevated AST	100.0% 1/1 • Number of events 1 • 10 months	— 0/0 • 10 months
Skin and subcutaneous tissue disorders MRSA recurrence	100.0% 1/1 • Number of events 1 • 10 months	— 0/0 • 10 months
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	100.0% 1/1 • Number of events 1 • 10 months	— 0/0 • 10 months
Skin and subcutaneous tissue disorders hair loss	100.0% 1/1 • Number of events 1 • 10 months	— 0/0 • 10 months
Musculoskeletal and connective tissue disorders leg cramps	100.0% 1/1 • Number of events 1 • 10 months	— 0/0 • 10 months
Gastrointestinal disorders loss of taste sensation	100.0% 1/1 • Number of events 1 • 10 months	— 0/0 • 10 months

Additional Information

Dr. Abel Torres, PI

Loma Linda University Health, Department of Dermatology

Phone: (909) 558-2055

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place