Trial Outcomes & Findings for Vismodegib in Basal Cell Carcinomas (BCC) Chemoprevention (NCT NCT02067104)

NCT ID: NCT02067104

Last Updated: 2019-08-14

Results Overview

Measured by the incidence of biopsy confirmed BCC over a 24 month period

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 9 participants
• Primary outcome timeframe: 24 Months
• Results posted on: 2019-08-14

Participant Flow

Participant milestones

Measure	Placebo receive 150 mg of oral placebo daily for a period of 2 months Placebo: Pulse therapy pattern of 2 months of daily treatment and 2 months of no treatment for 24 months.	Vismodegib receive 150 mg of vismodegib daily for a period of 2 months Vismodegib: Pulse therapy pattern of 2 months of daily treatment and 2 months of no treatment for 24 months.
Overall Study STARTED	4	5
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	4	5

Reasons for withdrawal

Measure	Placebo receive 150 mg of oral placebo daily for a period of 2 months Placebo: Pulse therapy pattern of 2 months of daily treatment and 2 months of no treatment for 24 months.	Vismodegib receive 150 mg of vismodegib daily for a period of 2 months Vismodegib: Pulse therapy pattern of 2 months of daily treatment and 2 months of no treatment for 24 months.
Overall Study Study termination due to low accrual	4	5

Baseline Characteristics

Vismodegib in Basal Cell Carcinomas (BCC) Chemoprevention

Baseline characteristics by cohort

Measure	Placebo n=4 Participants receive 150 mg of oral placebo daily for a period of 2 months Placebo: Pulse therapy pattern of 2 months of daily treatment and 2 months of no treatment for 24 months.	Vismodegib n=5 Participants receive 150 mg of vismodegib daily for a period of 2 months Vismodegib: Pulse therapy pattern of 2 months of daily treatment and 2 months of no treatment for 24 months.	Total n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	5 participants n=7 Participants	9 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 Months

Population: Early study termination due to low accrual. No data analyzed; no results.

Measured by the incidence of biopsy confirmed BCC over a 24 month period

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 Months

Population: Early study termination due to low accrual. No data analyzed; no results.

Measured by the incidence of biopsy confirmed SCC over the same 24 month period

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Vismodegib

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=4 participants at risk receive 150 mg of oral placebo daily for a period of 2 months Placebo: Pulse therapy pattern of 2 months of daily treatment and 2 months of no treatment for 24 months.	Vismodegib n=5 participants at risk receive 150 mg of vismodegib daily for a period of 2 months Vismodegib: Pulse therapy pattern of 2 months of daily treatment and 2 months of no treatment for 24 months.
Skin and subcutaneous tissue disorders Scale in ear	0.00% 0/4	20.0% 1/5
Gastrointestinal disorders Taste disturbance	25.0% 1/4	60.0% 3/5
Musculoskeletal and connective tissue disorders Leg cramps	75.0% 3/4	40.0% 2/5

Additional Information

Amy Selegue

University of Arizona

Phone: 520-626-0301

Email: aselegue@email.arizona.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place