Relationship Between Pharmacokinetics and Safety of Vismodegib - OPTIVISMO-1 (NCT03610022) | Clinical Trial Compass
CompletedPhase 4
Relationship Between Pharmacokinetics and Safety of Vismodegib - OPTIVISMO-1
France27 participantsStarted 2018-09-03
Plain-language summary
Vismodegib (ERIVEDGE®) at the standard dose of 150 mg/day orally is indicated for the treatment of advanced Basal Cell Carcinoma (BCC) and is associated with many adverse effects. Cramps, alopecia, dysgeusia, weight loss and others observed in clinical practice, compromize compliance and often lead to treatment discontinuation. Currently, it is the only drug available in this indication. Our main objective is to assess the relationship between plasma concentrations of vismodegib, and the occurrence of adverse effects within 6 months of inclusion in the study.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with BCC and annexial carcinoma histologically proven under treatment or new patients under vismodegib or patients who restarted treatment
* 18 years-old or older
* Complete medical record
* Members or beneficiaries of a social security system,
* Patients must have given informed consent, free and written.
Exclusion Criteria:
* Patients with or without BCC and not treated with vismodegib
* BCC patients who stopped treatment with vismodegib due to non-response or progression on treatment
* Patients under 18 years-old
* Patients whose medical record is incomplete
* Unaffiliated subjects or not beneficiaries of a security system social,
* Patients who have not been informed and have not given their consent, free and written,
* Pregnant and childbearing women without effective contraceptive method
* Patients with confusional state
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Serious side effects (grade 2 or more) during the clinical response follow-up to vismodegib
Timeframe: Occurrence from inclusion to 6 months visit