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Hedgehog Pathway Inhibitor
Vismodegib for Basal Cell Carcinoma
Phase < 1
Recruiting
Led By Zeynep Eroglu, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights
Study Summary
This trial compares 4 dosing schedules for advanced skin cancer to see which is best tolerated & effective.
Who is the study for?
Adults with advanced basal cell carcinoma can join this trial. They must be able to measure their tumor, have not used hedgehog inhibitors in the last 6 months, and have good liver, kidney, and bone marrow function. Pregnant or nursing women cannot participate; men and women must use contraception.Check my eligibility
What is being tested?
The study is testing four different dosing schedules of Vismodegib on patients with advanced basal cell carcinoma: two personalized intermittent doses compared to a fixed intermittent dose and a continuous regimen.See study design
What are the potential side effects?
Vismodegib may cause muscle cramps, hair loss, taste disturbance, weight loss, fatigue, nausea or diarrhea. It's important for participants to report any discomfort they experience during the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to Treatment Failure
Secondary outcome measures
Overall Response Rate
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Arm D: Personalized Intermittent Vismodegib (TGI model)Experimental Treatment1 Intervention
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.
Group II: Arm C: Personalized Intermittent Vismodegib (Adaptive)Experimental Treatment1 Intervention
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.
Group III: Arm B: Fixed Intermittent VismodegibExperimental Treatment1 Intervention
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.
Group IV: A: Continuous VismodegibActive Control1 Intervention
Participants will receive continuous 150 mg by mouth daily vismodegib as per commercially available package insert.
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Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
543 Previous Clinical Trials
135,448 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,109 Total Patients Enrolled
Zeynep Eroglu, MDPrincipal InvestigatorMoffitt Cancer Center
3 Previous Clinical Trials
100 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver, kidneys, and bone marrow are functioning well.I am not pregnant, do not plan to become pregnant, and am not nursing.I have had treatments for basal cell carcinoma, including hedgehog inhibitors over 6 months ago.I am not pregnant or I am incapable of becoming pregnant.I can take care of myself but might not be able to do heavy physical work.I am currently taking a statin or St. John's Wort.I have a skin tumor that can be measured with a ruler.I do not have any serious ongoing illnesses that are not under control.I am 18 years or older and have given my consent to participate.I had cancer before, but it's under control and I'm not on cancer drugs now.My cancer is an advanced basal cell carcinoma that has been confirmed by tests.I am using two forms of birth control, including a barrier method, during and for 24 months after therapy.I have been treated with a hedgehog inhibitor in the past 6 months.I agree not to donate blood while in the study and for 2 years after stopping vismodegib.
Research Study Groups:
This trial has the following groups:- Group 1: Arm C: Personalized Intermittent Vismodegib (Adaptive)
- Group 2: Arm D: Personalized Intermittent Vismodegib (TGI model)
- Group 3: A: Continuous Vismodegib
- Group 4: Arm B: Fixed Intermittent Vismodegib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has recruitment begun for this medical experiment?
"As indicated on clinicaltrials.gov, this medical trial is not currently recruiting patients; the last update being December 7th 2022. Nevertheless, a plethora of other trials are still looking for volunteers with 2493 alternatives available at present."
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