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

Use our guide to learn which trials are right for you!

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.


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
Palo Alto, California 94304
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
Atlanta, Georgia 30322
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
85 Herrick Street
Beverly, Massachusetts 01915
?
mi
from
Beverly, MA
Click here to add this to my saved trials
?
mi
from
Carmel, IN
Click here to add this to my saved trials
Charleston, South Carolina 29414
?
mi
from
Charleston, SC
Click here to add this to my saved trials
281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
?
mi
from
Hershey, PA
Click here to add this to my saved trials
?
mi
from
Innsbruck,
Click here to add this to my saved trials
8930 South Sepulveda Boulevard
Los Angeles, California 90045
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
725 West Granada Boulevard
Ormond Beach, Florida 32174
?
mi
from
Ormond Beach, FL
Click here to add this to my saved trials
201 Northwest 82nd Avenue
Plantation, Florida 33324
?
mi
from
Plantation, FL
Click here to add this to my saved trials
1755 South Grand Boulevard
Saint Louis, Missouri 63104
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Diego, California 92117
?
mi
from
San Diego, CA
Click here to add this to my saved trials
131 Stony Circle
Santa Rosa, California 95403
?
mi
from
Santa Rosa, CA
Click here to add this to my saved trials
?
mi
from
Smithtown, NY
Click here to add this to my saved trials
1253 Montauk Highway
West Islip, New York 11795
?
mi
from
West Islip, NY
Click here to add this to my saved trials
125 Sunnynoll Court
Winston-Salem, North Carolina 27106
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials