A Study of Two Vismodegib Regimens in Participants With Multiple Basal Cell Carcinomas
Status: | Completed |
---|---|
Conditions: | Skin Cancer, Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 9/30/2017 |
Start Date: | April 30, 2013 |
End Date: | August 31, 2016 |
A Randomized, Double-blinded, Regimen-controlled, Phase II, Multicenter Study to Assess the Efficacy and Safety of Two Different Vismodegib Regimens in Patients With Multiple Basal Cell Carcinomas
This randomized, double-blind, regimen-controlled, phase II, multicenter study will assess
the efficacy and safety of two different vismodegib regimens in participants with multiple
basal cell carcinoma. Participants will receive vismodegib 150 mg orally once daily either in
an intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo (Arm A) or as 24
weeks induction followed by an intermittent schedule of 8 weeks placebo followed by 8 weeks
vismodegib (Arm B). Anticipated time on study treatment is 72 weeks.
the efficacy and safety of two different vismodegib regimens in participants with multiple
basal cell carcinoma. Participants will receive vismodegib 150 mg orally once daily either in
an intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo (Arm A) or as 24
weeks induction followed by an intermittent schedule of 8 weeks placebo followed by 8 weeks
vismodegib (Arm B). Anticipated time on study treatment is 72 weeks.
Inclusion Criteria:
- Adult participants, >/= 18 years of age
- Participants with multiple basal cell carcinomas, including participants with Gorlin
syndrome, with at least 6 clinically evident basal cell carcinomas at the time of
randomization, of which 3 measure 5 mm or more in diameter and are considered target
lesions. All other lesions are considered to be non-target lesions
- Histopathologic confirmation that at least one of the three target lesions is basal
cell carcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- Adequate renal and hepatic function and hematopoietic capacity
- Women of childbearing potential must agree to use contraception as defined by protocol
during treatment and for at least 9 months after completion of study treatment
- Male participants with female partners of childbearing potential must agree to use
contraception as defined by protocol during treatment and for 2 months after
completion of study treatment
Exclusion Criteria:
- Inability or unwillingness to swallow capsules
- Pregnant or breastfeeding women
- Any metastatic basal cell carcinoma
- Locally advanced basal cell carcinoma lesion that is considered to be inoperable or to
have medical contraindications to surgery
- Recent (i.e., within the past 28 days prior to randomization) or current participation
in another experimental drug study
- Known or suspected alcohol abuse
- One of the following known rare hereditary conditions: galactose intolerance, primary
hypolactasia or glucose-galactose malabsorption
We found this trial at
18
sites
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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500 University Dr
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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201 Northwest 82nd Avenue
Plantation, Florida 33324
Plantation, Florida 33324
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1755 South Grand Boulevard
Saint Louis, Missouri 63104
Saint Louis, Missouri 63104
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660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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