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

27. mars 2017 oppdatert av: Hoffmann-La Roche

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

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

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

18

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo
Participants will receive matching placebo to vismodegib capsule orally once daily for 12 weeks.
Legemiddel: Placebo
Participants will receive matching placebo to vismodegib for 12 weeks.
Eksperimentell: Vismodegib
Participants will receive vismodegib 150 milligrams (mg) capsule orally once daily for 12 weeks.
Legemiddel: Vismodegib
Participants will receive vismodegib 150 mg oral capsule once a day for 12 weeks

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percent Change in Target Basal Cell Carcinoma (BCC) Expected Surgical Defect Area at Mohs Micrographic Surgery (MMS) Visit
Tidsramme: 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.
Baseline, MMS visit (Week 12-14)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Actual Change in Target BCC Expected Surgical Defect Area at MMS Visit
Tidsramme: 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).
Baseline, MSS Visit (Week 12-14)
Percentage Change in Target BCC Actual Tumor-Free Margin Excision Area at MMS Visit
Tidsramme: 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.
Baseline, MMS visit (Week 12-14)
Percentage of Participants With Clinical Response
Tidsramme: 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.
MMS visit (Week 12-14)
Percentage of Participants With Skip Area
Tidsramme: 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.
MMS visit (Week 12-14)
Percentage of Participants With BCC Recurrence
Tidsramme: Baseline, 12, 24, and 52 weeks post MMS Visit (MMS Visit = Week 12-14)
Baseline, 12, 24, and 52 weeks post MMS Visit (MMS Visit = Week 12-14)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hoffmann-La Roche

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

23. januar 2014

Primær fullføring (Faktiske)

26. januar 2016

Studiet fullført (Faktiske)

26. januar 2016

Datoer for studieregistrering

Først innsendt

3. juli 2013

Først innsendt som oppfylte QC-kriteriene

9. juli 2013

Først lagt ut (Anslag)

12. juli 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. mai 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. mars 2017

Sist bekreftet

1. mars 2017

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ML28726

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Forhold

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