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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01898598
Recruitment Status : Terminated
First Posted : July 12, 2013
Results First Posted : May 8, 2017
Last Update Posted : May 8, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
This randomized, double-blind, placebo-controlled study will assess the efficacy and safety of vismodegib with surgery in participants with basal cell carcinoma.

Condition or disease Intervention/treatment Phase
Basal Cell Carcinoma Drug: Placebo Drug: Vismodegib Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
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
Actual Study Start Date : January 23, 2014
Actual Primary Completion Date : January 26, 2016
Actual Study Completion Date : January 26, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Vismodegib

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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).

  2. 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.

  3. 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.

  4. 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.

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01898598


Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01898598    
Other Study ID Numbers: ML28726
First Posted: July 12, 2013    Key Record Dates
Results First Posted: May 8, 2017
Last Update Posted: May 8, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell