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Vismodegib in Basal Cell Carcinomas (BCC) Chemoprevention

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ClinicalTrials.gov Identifier: NCT02067104
Recruitment Status : Terminated (Low enrollment)
First Posted : February 20, 2014
Results First Posted : July 31, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
University of Arizona

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).

Condition or disease Intervention/treatment Phase
Basal Cell Carcinomas Drug: Vismodegib Drug: Placebo Phase 2

Detailed Description:

The primary objective of this study will be to determine if vismodegib pulse therapy will significantly reduce the incidence of newly diagnosed basal cell carcinomas (BCC) in high risk individuals when compared with placebo, as measured by the incidence of biopsy confirmed BCC over a 24 month period.

The secondary objective will be to determine that there will be no difference in the incidence of newly diagnosed squamous cell carcinomas (SCC) in the same subjects receiving vismodegib treatment when compared with placebo, as measured by the incidence of biopsy confirmed SCC over the same 24 month period.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Placebo Controlled Double-Blind Study to Evaluate the Efficacy of Vismodegib as Chemoprevention of New Bcc Development in High Risk Subjects
Actual Study Start Date : February 17, 2014
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Vismodegib

Arm Intervention/treatment
Placebo Comparator: Placebo
receive 150 mg of oral placebo daily for a period of 2 months
Drug: Placebo
Pulse therapy pattern of 2 months of daily treatment and 2 months of no treatment for 24 months.

Experimental: Vismodegib
receive 150 mg of vismodegib daily for a period of 2 months
Drug: Vismodegib
Pulse therapy pattern of 2 months of daily treatment and 2 months of no treatment for 24 months.
Other Name: Erivedge




Primary Outcome Measures :
  1. The Effect of Vismodegib Pulse Therapy on the Incidence of Newly Diagnosed Basal Cell Carcinomas (BCC) [ Time Frame: 24 Months ]
    Measured by the incidence of biopsy confirmed BCC over a 24 month period


Secondary Outcome Measures :
  1. The Incidence of Newly Diagnosed Squamous Cell Carcinomas (SCC) in the Same Subjects Receiving Vismodegib Treatment When Compared With Placebo [ Time Frame: 24 Months ]
    Measured by the incidence of biopsy confirmed SCC over the same 24 month period



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02067104


Locations
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United States, Arizona
University of Arizona Cancer Center
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
University of Arizona
Investigators
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Principal Investigator: Clara Curiel-Lewandroski University of Arizona

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Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT02067104     History of Changes
Other Study ID Numbers: 1401183410
ML28585 ( Other Identifier: Genentech BioOncology )
First Posted: February 20, 2014    Key Record Dates
Results First Posted: July 31, 2019
Last Update Posted: August 14, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell