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Trial record 32 of 78 for:    vismodegib

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

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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

Tracking Information
First Submitted Date  ICMJE July 3, 2013
First Posted Date  ICMJE July 12, 2013
Results First Submitted Date  ICMJE March 27, 2017
Results First Posted Date  ICMJE May 8, 2017
Last Update Posted Date May 8, 2017
Actual Study Start Date  ICMJE January 23, 2014
Actual Primary Completion Date January 26, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 9, 2013)
Percent change in basal cell carcinoma tumor area [ Time Frame: From baseline to 12-14 weeks ]
Change History Complete list of historical versions of study NCT01898598 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2017)
  • 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) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2013)
  • Complete response rate [ Time Frame: From baseline to 12-14 weeks ]
  • Partial response rate [ Time Frame: From baseline to 12-14 weeks ]
  • Actual change in target basal cell carcinoma tumor area [ Time Frame: From baseline to 12-14 weeks ]
  • Occurrence of unconnected residual tumor [ Time Frame: From baseline to 12-14 weeks ]
  • Safety: Incidence of adverse events [ Time Frame: 100 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Vismodegib With Surgery in Participants With Previously Untreated Basal Cell Carcinoma
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Basal Cell Carcinoma
Intervention  ICMJE
  • Drug: Placebo
    Participants will receive matching placebo to vismodegib for 12 weeks.
  • Drug: Vismodegib
    Participants will receive vismodegib 150 mg oral capsule once a day for 12 weeks
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Participants will receive matching placebo to vismodegib capsule orally once daily for 12 weeks.
    Intervention: Drug: Placebo
  • Experimental: Vismodegib
    Participants will receive vismodegib 150 milligrams (mg) capsule orally once daily for 12 weeks.
    Intervention: Drug: Vismodegib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 3, 2015)
18
Original Estimated Enrollment  ICMJE
 (submitted: July 9, 2013)
75
Actual Study Completion Date  ICMJE January 26, 2016
Actual Primary Completion Date January 26, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01898598
Other Study ID Numbers  ICMJE ML28726
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP