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

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ClinicalTrials.gov Identifier: NCT01815840
Recruitment Status : Completed
First Posted : March 21, 2013
Results First Posted : August 4, 2016
Last Update Posted : September 28, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE March 19, 2013
First Posted Date  ICMJE March 21, 2013
Results First Submitted Date  ICMJE June 27, 2016
Results First Posted Date  ICMJE August 4, 2016
Last Update Posted Date September 28, 2017
Actual Study Start Date  ICMJE April 30, 2013
Actual Primary Completion Date August 27, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 19, 2013)
Relative reduction (%) from baseline in the number of clinically evident basal cell carcinomas at Week 73 (after 72 weeks of treatment) [ Time Frame: from baseline to Week 73 ]
Change History Complete list of historical versions of study NCT01815840 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2016)
  • 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.
  • 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.
  • Percentage of Participants With at Least 50% Reduction in the Number of Basal Cell Carcinomas at Week 73 [ Time Frame: Baseline; Week 73 ]
  • Percentage of Participants With New Basal Cell Carcinomas at Week 73 [ Time Frame: Baseline; Week 73 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Percentage of Participants Experiencing Any Adverse Event [ Time Frame: Up to 125 weeks ]
  • 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").
  • 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").
  • 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").
Original Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2013)
  • Drop-out rate: Discontinuation of study treatment prior to Week 73 for either adverse events or withdrawal of consent by the patient [ Time Frame: approximately 3.5 years ]
  • Relative reduction (%) from baseline in total size of three target basal cell carcinoma lesions in individual patients at Week 73 [ Time Frame: from baseline to Week 73 ]
  • Proportion of patients with at least 50% reduction in the number of basal cell carcinomas at Week 73 in the two treatment regimens [ Time Frame: approximately 3.5 years ]
  • Number of new basal cell carcinomas at Week 73 in the two treatment groups [ Time Frame: approximately 3.5 years ]
  • Recurrence rate up to Week 125 (52 weeks after study drug discontinuation) [ Time Frame: approximately 3.5 years ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 3.5 years ]
  • Patient reported outcomes: Skindex-16 tool [ Time Frame: approximately 3.5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Two Vismodegib Regimens in Participants With Multiple Basal Cell Carcinomas
Official Title  ICMJE 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
Brief Summary 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.
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: Vismodegib
    Vismodegib 150 mg hard gelatin capsule orally once daily
    Other Name: Erivedge®
  • Drug: Placebo
    Vismodegib placebo orally once daily
Study Arms  ICMJE
  • Experimental: Vismodegib Intermittent Schedule
    Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
    Interventions:
    • Drug: Vismodegib
    • Drug: Placebo
  • Experimental: Vismodegib Induction Followed by Intermittent Schedule
    Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
    Interventions:
    • Drug: Vismodegib
    • Drug: Placebo
Publications *

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: September 1, 2015)
229
Original Estimated Enrollment  ICMJE
 (submitted: March 19, 2013)
200
Actual Study Completion Date  ICMJE August 31, 2016
Actual Primary Completion Date August 27, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 Austria,   Canada,   France,   Germany,   Italy,   Mexico,   Netherlands,   Russian Federation,   Spain,   United States
Removed Location Countries Brazil
 
Administrative Information
NCT Number  ICMJE NCT01815840
Other Study ID Numbers  ICMJE MO28295
2012-003305-10 ( EudraCT Number )
Has Data Monitoring Committee Yes
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 August 2017

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