Adaptive Therapy of Vismodegib in Advanced Basal Cell Carcinoma

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT05651828
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Advanced Basal Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vismodegib 150 MG Oral Capsule — DRUG
    Vismodegib is a hedgehog signalling pathway target agent. Participants will self-administer the standard 150 mg dose by mouth.

Study Details

The purpose of this study is to compare how well tolerated and effective four different dosing schedules (two personalized, intermittent dosing schedules as compared to a fixed intermittent and continuous dosing regimen) work in people with advanced basal cell carcinoma.

Key Dates

Start date
Mar 23, 2023
Status verified
Mar 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
34 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: A: Continuous Vismodegib
    Participants will receive continuous 150 mg by mouth daily vismodegib as per commercially available package insert.
  • Experimental: Arm B: Fixed Intermittent Vismodegib
    Participants will receive intermittent 150 mg dose vismodegib by mouth with a 12 weeks on/8 weeks off regimen. Participants will take vismodegib for first 12 weeks, then off 8 weeks, and alternate in fixed cycles.
  • Experimental: Arm C: Personalized Intermittent Vismodegib (Adaptive)
    Participants will start with an 8-week run in period with vismodegib 150 mg dose by mouth daily. Participants will take vismodegib for the first 8 weeks, then start personalized dosing based on specific model.
  • Experimental: Arm D: Personalized Intermittent Vismodegib (TGI model)
    Participants will start with an 8-week run in period with vismodegib 150 mg dose by mouth daily. Participants will take vismodegib for the first 8 weeks, then start personalized dosing based on TGI model.

Primary Outcome Measure

Time to Treatment Failure [ Time Frame: Up to 36 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33617
Zeynep Eroglu, MD (PRINCIPAL_INVESTIGATOR)
Andrew Brohl, MD (SUB_INVESTIGATOR)
Nikhil Khushalani, MD (SUB_INVESTIGATOR)
Ahmad Tarhini, MD, PhD (SUB_INVESTIGATOR)

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By research site
Moffitt Cancer Center· Tampa, FL

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