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NCT Number: NCT01815840

A Study of Two Vismodegib Regimens in Participants With Multiple Basal Cell Carcinomas

This randomized, double-blind, regimen-controlled, phase II, multicenter study will assess the efficacy and safety of two different vismodegib regimens in participants with multiple basal cell carcinoma. Participants will receive vismodegib 150 mg orally once daily either in an intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo (Arm A) or as 24 weeks induction followed by an intermittent schedule of 8 weeks placebo followed by 8 weeks vismodegib (Arm B). Anticipated time on study treatment is 72 weeks.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

LKH Innsbruck; Universitätsklinik für Dermatologie, Innsbruck, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult participants, >/= 18 years of age
  • Participants with multiple basal cell carcinomas, including participants with Gorlin syndrome, with at least 6 clinically evident basal cell carcinomas at the time of randomization, of which 3 measure 5 mm or more in diameter and are considered target lesions. All other lesions are considered to be non-target lesions
  • Histopathologic confirmation that at least one of the three target lesions is basal cell carcinoma
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  • Adequate renal and hepatic function and hematopoietic capacity
  • Women of childbearing potential must agree to use contraception as defined by protocol during treatment and for at least 9 months after completion of study treatment
  • Male participants with female partners of childbearing potential must agree to use contraception as defined by protocol during treatment and for 2 months after completion of study treatment

Exclusion criteria

  • Inability or unwillingness to swallow capsules
  • Pregnant or breastfeeding women
  • Any metastatic basal cell carcinoma
  • Locally advanced basal cell carcinoma lesion that is considered to be inoperable or to have medical contraindications to surgery
  • Recent (i.e., within the past 28 days prior to randomization) or current participation in another experimental drug study
  • Known or suspected alcohol abuse
  • One of the following known rare hereditary conditions: galactose intolerance, primary hypolactasia or glucose-galactose malabsorption

Treatment and study plan

vismodegib

Drug

Vismodegib 150 mg hard gelatin capsule orally once daily

Other names: Erivedge®

Placebo

Drug

Vismodegib placebo orally once daily

Primary outcomes

  1. Mean Percent Change From Baseline in the Number of Clinically Evident Basal Cell Carcinomas at Week 73 (After 72 Weeks of Treatment)

    Time frame: Baseline; Week 73

    The total number of clinically evident basal cell carcinomas = the total number of target and/or non-target lesions present in individual participants.

Secondary outcomes

  1. Percentage of Participants Who Discontinued Study Treatment Due to Tolerability Issues

    Time frame: Baseline to Week 73

    The percentage of participants who discontinued study treatment (due either to adverse event, refusal of treatment, or withdrawal of consent) was summarized by treatment group.

  2. Mean Percent Change From Baseline in Total Size of Three Target Basal Cell Carcinoma Lesions in Individual Participants at Week 73

    Time frame: Baseline; Week 73

    The three target basal cell carcinoma lesions = the three largest visible lesions, at least 5 mm in the longest diameter, in individual participants.

  3. Percentage of Participants With at Least 50% Reduction in the Number of Basal Cell Carcinomas at Week 73

    Time frame: Baseline; Week 73

  4. Percentage of Participants With New Basal Cell Carcinomas at Week 73

    Time frame: Baseline; Week 73

  5. Percent Change in Total Number of Basal Cell Carcinomas Relative to Baseline at Week 85 (12 Weeks Following End of Treatment) (Recurrence Rate)

    Time frame: Baseline; Week 85

  6. Percent Change in Total Number of Basal Cell Carcinomas Relative to Baseline at Week 97 (24 Weeks Following End of Treatment) (Recurrence Rate)

    Time frame: Baseline; Week 97

  7. Percent Change in Total Number of Basal Cell Carcinomas Relative to Baseline at Week 125 (52 Weeks Following End of Treatment) (Recurrence Rate)

    Time frame: Baseline; Week 125

  8. Percentage of Participants Experiencing Any Adverse Event

    Time frame: Up to 125 weeks

  9. Percent Change From Baseline in the Skindex-16 Symptom Domain Score at Week 73

    Time frame: Baseline; Week 73

    The Skindex-16 is a patient-reported outcome health questionnaire. Participants were asked about their symptoms, and their answers were combined into a composite Symptom Domain Score. Scores range from 0 ("never bothered") to 100 ("always bothered").

  10. Percent Change From Baseline in the Skindex-16 Emotion Domain Score at Week 73

    Time frame: Baseline; Week 73

    The Skindex-16 is a patient-reported outcome health questionnaire. Participants were asked about their emotional state, and their answers were combined into a composite Emotion Domain Score. Scores range from 0 ("never bothered") to 100 ("always bothered").

  11. Percent Change From Baseline in the Skindex-16 Function Domain Score at Week 73

    Time frame: Baseline; Week 73

    The Skindex-16 is a patient-reported outcome health questionnaire. Participants were asked about their ability to function, and answers were combined into a composite Function Domain Score. Scores range from 0 ("never bothered") to 100 ("always bothered").

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Randomized, Double-blinded, Regimen-controlled, Phase II, Multicenter Study to Assess the Efficacy and Safety of Two Different Vismodegib Regimens in Patients With Multiple Basal Cell Carcinomas

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Mar 21, 2013
Registry last updated
Sep 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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