Vismodegib in Basal Cell Carcinomas (BCC) Chemoprevention

NCT02067104 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: 1401183410ML28585
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single site double blinded Phase II study to evaluate the chemopreventative effectiveness of vismodegib in the treatment of subjects at high risk for developing basal cell carcinomas (BCC).

Conditions

Basal Cell Carcinomas

Outcome Measures

Primary Outcomes (1)

• The Effect of Vismodegib Pulse Therapy on the Incidence of Newly Diagnosed Basal Cell Carcinomas (BCC)

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

  24 Months

Secondary Outcomes (1)

• The Incidence of Newly Diagnosed Squamous Cell Carcinomas (SCC) in the Same Subjects Receiving Vismodegib Treatment When Compared With Placebo

  24 Months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

receive 150 mg of oral placebo daily for a period of 2 months

Drug: Placebo

Vismodegib

EXPERIMENTAL

receive 150 mg of vismodegib daily for a period of 2 months

Drug: Vismodegib

Interventions

Vismodegib DRUG

Pulse therapy pattern of 2 months of daily treatment and 2 months of no treatment for 24 months.

Also known as: Erivedge

Vismodegib

Placebo DRUG

Pulse therapy pattern of 2 months of daily treatment and 2 months of no treatment for 24 months.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects
• Comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• At least 18 years of age at the time of informed consent.
• History of 3 or more biopsy confirmed BCCs in the preceding 2 years, calculated from 2 years prior to the screening visit.
• No active skin cancers.
• Women of reproductive potential must agree to use two forms of acceptable contraception
• Male subjects must agree to use condoms at all times, even after a vasectomy, during sexual intercourse with female partners of reproductive potential during treatment with vismodegib and for 2 months after the last dose to avoid exposing a pregnant partner and the unborn fetus to vismodegib.
• Male patients must agree not to donate sperm during the study and for 2 months after discontinuation of vismodegib
• Agreement not to donate blood or blood products during the study and for 7 months after the last dose.
• Ability to understand and the willingness to sign a written informed consent document in English

You may not qualify if:

• Women who are pregnant or lactating, or planning pregnancy while enrolled in the study or for 7 months after the last dose of the study drug.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Subjects with clinically stable chronic medical conditions including, but not limited to, controlled hypertension, diabetes mellitus type II, hypercholesterolemia, or osteoarthritis, will be allowed to enter the study.
• Inability or unwillingness to swallow capsules.
• Have a history of alcohol of substance abuse, unless in full remission for greater than 6 months prior to the screening visit (Day 0) when the consent form is signed.
• Known to be infected with human immunodeficiency virus (HIV), hepatitis B or hepatitis C viruses.
• Currently receiving vismodegib, biologics or chemotherapy
• Currently undergoing treatment with photodynamic therapy, topical chemotherapy agents including Imiquimod, fluorouracil
• Subjects who have Gorlins syndrome
• Subjects who have received any type of solid organ transplant
• Subjects taking immunosuppressive medications at the screening visit. (Day 0)
• Participation in other study using an investigational or experimental therapy or procedure within 4 weeks or 5 half-lives (whichever is longer) before the screening visit and/or during study participation. Subjects cannot participate in studies of other investigational or experimental therapies or procedures at any time during their participation in this study.
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
• Subjects unable or unwilling to comply with the study visit schedule and requirements of the study
• Subjects unable to speak and read the English language
• A subject who, in the opinion of the sponsor-investigator will be uncooperative or unable to comply with study procedures.

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

HhAntag691

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Results Point of Contact

• Title: Amy Selegue
• Organization: University of Arizona

aselegue@email.arizona.edu

520-626-0301

Study Officials

• Clara Curiel-Lewandroski

  University of Arizona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2014
• First Posted: February 20, 2014
• Study Start: February 17, 2014
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: August 14, 2019
• Results First Posted: July 31, 2019

Record last verified: 2019-07

Locations

US (1)