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

NCT01898598 | Terminated Phase 2 Results

• 1 other identifier: ML28726
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 21

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.

Conditions

Basal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Percent Change in Target Basal Cell Carcinoma (BCC) Expected Surgical Defect Area at Mohs Micrographic Surgery (MMS) Visit

  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.

  Baseline, MMS visit (Week 12-14)

Secondary Outcomes (5)

• Actual Change in Target BCC Expected Surgical Defect Area at MMS Visit

  Baseline, MSS Visit (Week 12-14)

• Percentage Change in Target BCC Actual Tumor-Free Margin Excision Area at MMS Visit

  Baseline, MMS visit (Week 12-14)

• Percentage of Participants With Clinical Response

  MMS visit (Week 12-14)

• Percentage of Participants With Skip Area

  MMS visit (Week 12-14)

• Percentage of Participants With BCC Recurrence

  Baseline, 12, 24, and 52 weeks post MMS Visit (MMS Visit = Week 12-14)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo to vismodegib capsule orally once daily for 12 weeks.

Drug: Placebo

Vismodegib

EXPERIMENTAL

Participants will receive vismodegib 150 milligrams (mg) capsule orally once daily for 12 weeks.

Drug: Vismodegib

Interventions

Placebo DRUG

Participants will receive matching placebo to vismodegib for 12 weeks.

Placebo

Vismodegib DRUG

Participants will receive vismodegib 150 mg oral capsule once a day for 12 weeks

Vismodegib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (21)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

Moy-Fincher-Chipps Facial Plastics and Dermatology

Beverly Hills, California, 90210, United States

Location

Scripps Clinic

La Jolla, California, 92037, United States

Location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Stanford University

Palo Alto, California, 94305, United States

Location

California Pacific Medical Center

San Francisco, California, 94107, United States

Location

Univ of Calif-San Francisco

San Francisco, California, 94115, United States

Location

Spencer Derma & Skin Surg Ctr

St. Petersburg, Florida, 33716, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Laser & Skin Surgery Center of Indiana

Carmel, Indiana, 46032, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Beth Israel Cancer Center; West Campus

New York, New York, 10011, United States

Location

University of Rochester Medical Center; University Dermatology Associates

Rochester, New York, 14642, United States

Location

Mariwalla Dermatology

West Islip, New York, 11795, United States

Location

The Skin Surgery Center

Winston-Salem, North Carolina, 27106, United States

Location

Oregon Health & Science University; Department of Dermatology

Portland, Oregon, 97239-4501, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030-4095, United States

Location

Huntsman Cancer Institute at The University of Utah

Salt Lake City, Utah, 84112, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

HhAntag691

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Limitations and Caveats

The study was discontinued early by the Sponsor and due to a small sample size, no conclusions can be drawn.

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2013
• First Posted: July 12, 2013
• Study Start: January 23, 2014
• Primary Completion: January 26, 2016
• Study Completion: January 26, 2016
• Last Updated: May 8, 2017
• Results First Posted: May 8, 2017

Record last verified: 2017-03

Locations

US (21)