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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Basal Cell Carcinoma

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Trial Information

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


Inclusion Criteria:



- Adult patients, >/= 18 years of age

- Patients with multiple basal cell carcinomas, including patients with Gorlin
syndrome, with at least 6 clinically evident basal cell carcinomas at the time of
randomization, at least 3 of which measure 5 mm or more in diameter (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 7 months after completion of study
treatment

- Male patients 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Relative reduction (%) from baseline in the number of clinically evident basal cell carcinomas at Week 73 (after 72 weeks of treatment)

Outcome Time Frame:

from baseline to Week 73

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

MO28295

NCT ID:

NCT01815840

Start Date:

April 2013

Completion Date:

February 2017

Related Keywords:

  • Basal Cell Carcinoma
  • Carcinoma
  • Carcinoma, Basal Cell
  • Hamartoma Syndrome, Multiple

Name

Location

Albany, Georgia  31701
Fountain Valley, California  92708
Columbia, Missouri  65203
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Boston, Massachusetts  
Eugene, Oregon  
Indianapolis, Indiana