A Study of Two Vismodegib Regimens in Patients With Multiple Basal Cell Carcinomas

This study is currently recruiting participants.
Verified April 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01815840
First received: March 19, 2013
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

This randomized, double-blind, regimen-controlled, phase II, multicenter study will assess the efficacy and safety of two different vismodegib regimens in patients with multiple basal cell carcinoma. Patients 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.


Condition Intervention Phase
Basal Cell Carcinoma
Drug: vismodegib
Drug: placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Relative reduction (%) from baseline in the number of clinically evident basal cell carcinomas at Week 73 (after 72 weeks of treatment) [ Time Frame: from baseline to Week 73 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Drop-out rate: Discontinuation of study treatment prior to Week 73 for either adverse events or withdrawal of consent by the patient [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Relative reduction (%) from baseline in total size of three target basal cell carcinoma lesions in individual patients at Week 73 [ Time Frame: from baseline to Week 73 ] [ Designated as safety issue: No ]
  • Proportion of patients with at least 50% reduction in the number of basal cell carcinomas at Week 73 in the two treatment regimens [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Number of new basal cell carcinomas at Week 73 in the two treatment groups [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Recurrence rate up to Week 125 (52 weeks after study drug discontinuation) [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Patient reported outcomes: Skindex-16 tool [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A: Vismodegib intermittent schedule Drug: vismodegib
150 mg orally once daily, 72 weeks intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib
Experimental: Vismodegib induction followed by intermittent schedule Drug: vismodegib
150 mg orally once daily, 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib up to Week 72
Drug: placebo
orally daily, intermittent with vismodegib

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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, 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 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
  • Known or suspected alcohol abuse
  • One of the following known rare hereditary conditions: galactose intolerance, primary hypolactasia or glucose-galactose malabsorption
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01815840

Contacts
Contact: Reference Study ID Number: MO28295 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 66 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01815840     History of Changes
Other Study ID Numbers: MO28295, 2012-003305-10
Study First Received: March 19, 2013
Last Updated: April 14, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Basal Cell
Carcinoma
Hamartoma Syndrome, Multiple
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Hamartoma
Neoplasms, Multiple Primary
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on April 17, 2014