A Study of Vismodegib With Surgery in Patients With Previously Untreated Basal Cell Carcinoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01898598
First received: July 3, 2013
Last updated: September 22, 2014
Last verified: September 2014
  Purpose

This randomized, double-blind, placebo-controlled study will assess the efficacy and safety of vismodegib with surgery in patients with basal cell carcinoma. P atients will be randomized to receive oral daily doses of vismodegib 150 mg or m atching placebo. The anticipated time on study drug treatment is 12 weeks.


Condition Intervention Phase
Basal Cell Carcinoma
Drug: Placebo
Drug: vismodegib
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-Blind, Placebo-Controlled, Phase II Study To Assess The Efficacy And Safety Of Oral Vismodegib For The Treatment Of Basal Cell Carcinoma Preceding Excision By Mohs Micrographic Surgery

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percent change in surgical defect area [ Time Frame: From baseline to 12-14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complete response rate [ Time Frame: From baseline to 12-14 weeks ] [ Designated as safety issue: No ]
  • Partial response rate [ Time Frame: From baseline to 12-14 weeks ] [ Designated as safety issue: No ]
  • Actual change in expected surgical defect area [ Time Frame: From baseline to 12-14 weeks ] [ Designated as safety issue: No ]
  • Occurrence of unconnected residual tumor [ Time Frame: From baseline to 12-14 weeks ] [ Designated as safety issue: No ]
  • Percent change in actual tumor-free margin excision area [ Time Frame: From baseline to 12-14 weeks ] [ Designated as safety issue: No ]
  • Cumulative recurrence rate of the target basal cell carcinoma at Weeks 12, 24, and 52 post-surgery [ Time Frame: Weeks 12, 24 and 52 ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 100 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: February 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Arm Drug: Placebo
Matching placebo to vismodegib
Experimental: Vismodegib Arm Drug: vismodegib
vismodegib 150 mg oral doses once a day for 12 weeks

  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
  • Diagnosis of non-infected, not recurrent, previously untreated basal cell carcinoma
  • Free of any significant physical abnormalities (e.g., tattoos) at the target basal cell carcinoma site
  • Willing and able to participate in the study as an outpatient and agreement to make frequent visits to the clinic during the treatment and follow-up periods and to comply with study requirements

Exclusion Criteria:

  • Prior treatment with vismodegib
  • Known hypersensitivity to any of the study drug excipients
  • Any metastatic basal cell carcinoma
  • Any locally advanced basal cell carcinoma considered to be inoperable or to have a medical contraindication to surgery
  • Evidence of clinically significant and unstable diseases or conditions (e.g., cardiovascular, immunosuppressive, hematologic)
  • Any dermatological disease at the target basal cell carcinoma site that may cause difficulty with examination
  • Recent, current, or planned participation in another experimental drug study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01898598

Contacts
Contact: Reference Study ID Number: ML28726 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
United States, Arizona
Recruiting
Scottsdale, Arizona, United States, 85259
United States, California
Recruiting
Beverly Hills, California, United States, 90210
Recruiting
La Jolla, California, United States, 92037
Recruiting
Loma Linda, California, United States, 92354
Recruiting
Palo Alto, California, United States, 94305
Recruiting
San Francisco, California, United States, 94107
Recruiting
San Francisco, California, United States, 94115
United States, Florida
Recruiting
St. Petersburg, Florida, United States, 33716
United States, Illinois
Recruiting
Chicago, Illinois, United States, 60611
United States, Indiana
Recruiting
Carmel, Indiana, United States, 46032
United States, Minnesota
Recruiting
Minneapolis, Minnesota, United States, 55455
United States, New York
Recruiting
New York, New York, United States, 10011
Recruiting
Rochester, New York, United States, 14623
Recruiting
West Islip, New York, United States, 11795
United States, North Carolina
Not yet recruiting
Winston-Salem, North Carolina, United States, 27106
United States, Oregon
Recruiting
Portland, Oregon, United States, 97239-4501
United States, Pennsylvania
Recruiting
Hershey, Pennsylvania, United States, 17033
Recruiting
Philadelphia, Pennsylvania, United States, 19111
United States, Texas
Recruiting
Houston, Texas, United States, 77030-4095
United States, Utah
Recruiting
Salt Lake City, Utah, United States, 84112
United States, Wisconsin
Recruiting
Madison, Wisconsin, United States, 53705
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: NCT01898598     History of Changes
Other Study ID Numbers: ML28726
Study First Received: July 3, 2013
Last Updated: September 22, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell

ClinicalTrials.gov processed this record on October 02, 2014