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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01898598
First received: July 3, 2013
Last updated: March 27, 2017
Last verified: March 2017
  Purpose
This randomized, double-blind, placebo-controlled study will assess the efficacy and safety of vismodegib with surgery in participants with basal cell carcinoma.

Condition Intervention Phase
Basal Cell Carcinoma Drug: Placebo Drug: Vismodegib Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Target Basal Cell Carcinoma (BCC) Expected Surgical Defect Area at Mohs Micrographic Surgery (MMS) Visit [ Time Frame: Baseline, MMS visit (Week 12-14) ]
    The percent change in target BCC expected surgical defect area was defined as ([baseline expected surgical defect area − expected surgical defect area at MMS visit]/ baseline expected surgical defect area) × 100 percent (%) where expected surgical defect area was manually outlined on a digital photograph and measured by a computer (computer aided planimetry). MMS visit was defined as the visit that occurred within 2 weeks of the last study treatment.


Secondary Outcome Measures:
  • Actual Change in Target BCC Expected Surgical Defect Area at MMS Visit [ Time Frame: Baseline, MSS Visit (Week 12-14) ]
    Actual change was defined as (baseline expected surgical defect area - expected surgical defect area at MMS visit). MMS visit was defined as the visit that occurred within 2 weeks of the last study treatment. Expected surgical defect area was manually outlined on a digital photograph and measured by a computer (computer aided planimetry).

  • Percentage Change in Target BCC Actual Tumor-Free Margin Excision Area at MMS Visit [ Time Frame: Baseline, MMS visit (Week 12-14) ]
    Percent change in target BCC actual tumor-free margin excision area was defined as = (expected surgical defect area pre-treatment - actual tumor-free margin excision area at MMS visit) / expected surgical defect area pre-treatment) * 100%. The actual tumor-free margin excision area (includes 2 millimeters [mm] margin) was measured during MMS. The area was photographed and traced on the digital photograph then calculated by computer-aided planimetry. MMS visit was defined as the visit that occurred within 2 weeks of the last study treatment.

  • Percentage of Participants With Clinical Response [ Time Frame: MMS visit (Week 12-14) ]
    Clinical response was defined as a complete response (CR) or partial response (PR) at the post-treatment MMS excision. CR was defined as no histological evidence of BCC. PR was defined as a reduction of at least 50 % in the expected surgical defect area with histologic evidence of residual BCC. MMS visit was defined the visit that occurred within 2 weeks of the last study treatment.

  • Percentage of Participants With Skip Area [ Time Frame: MMS visit (Week 12-14) ]
    Skip area was defined as the presence of non-contiguous residual tumor at the MMS visit, as determined by an independent dermatopathologist. MMS visit occurred within 2 weeks of the last study treatment.

  • Percentage of Participants With BCC Recurrence [ Time Frame: Baseline, 12, 24, and 52 weeks post MMS Visit (MMS Visit = Week 12-14) ]

Enrollment: 18
Actual Study Start Date: January 23, 2014
Study Completion Date: January 26, 2016
Primary Completion Date: January 26, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Participants will receive matching placebo to vismodegib capsule orally once daily for 12 weeks.
Drug: Placebo
Participants will receive matching placebo to vismodegib for 12 weeks.
Experimental: Vismodegib
Participants will receive vismodegib 150 milligrams (mg) capsule orally once daily for 12 weeks.
Drug: Vismodegib
Participants will receive vismodegib 150 mg oral capsule once a day for 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Locations
United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
United States, California
Moy-Fincher-Chipps Facial Plastics and Dermatology
Beverly Hills, California, United States, 90210
Scripps Clinic
La Jolla, California, United States, 92037
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Stanford University
Palo Alto, California, United States, 94305
California Pacific Medical Center
San Francisco, California, United States, 94107
Univ of Calif-San Francisco
San Francisco, California, United States, 94115
United States, Florida
Spencer Derma & Skin Surg Ctr
St. Petersburg, Florida, United States, 33716
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Indiana
Laser & Skin Surgery Center of Indiana
Carmel, Indiana, United States, 46032
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, New York
Beth Israel Cancer Center; West Campus
New York, New York, United States, 10011
University of Rochester Medical Center; University Dermatology Associates
Rochester, New York, United States, 14642
Mariwalla Dermatology
West Islip, New York, United States, 11795
United States, North Carolina
The Skin Surgery Center
Winston-Salem, North Carolina, United States, 27106
United States, Oregon
Oregon Health & Science University; Department of Dermatology
Portland, Oregon, United States, 97239-4501
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030-4095
United States, Utah
Huntsman Cancer Institute at The University of Utah
Salt Lake City, Utah, United States, 84112
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01898598     History of Changes
Other Study ID Numbers: ML28726
Study First Received: July 3, 2013
Results First Received: March 27, 2017
Last Updated: March 27, 2017

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 September 20, 2017