Efficacy of Palbociclib in Advanced Acral Melanoma With Cell Cycle Gene Aberrations (NCT03454919) | Clinical Trial Compass
UnknownPhase 2
Efficacy of Palbociclib in Advanced Acral Melanoma With Cell Cycle Gene Aberrations
60 participantsStarted 2018-03-30
Plain-language summary
It is a prospective, phase II, open-labeled, clinical trial aimed to determine the efficacy of palbociclib in advanced melanoma patients who bear gene aberrations in cell cycle pathways \[including CDK4 amplification and/or CCND1 amplification and/or P16 (CDKN2A) loss\]. Fifteen patients, if there is a response then further 45 patients will be enrolled. Totally 60 subjects with known above-mentioned gene aberrations who comply with the inclusion and exclusion criteria will be enrolled, their serum samples (at the time of the first administration of palbociclib and every 4 weeks afterwards) will be collected. Palbociclib will be given in the dose of 125 mg orally qd d1-21 every 28 days, unless disease progression or intolerance. All patients will be evaluated for the response to palbociclib by Response Evaluation Criteria in Solid Tumors (RECIST) at baseline. The standard radiographic imaging (CT scans) will be performed every 4 weeks until the end of treatment.
Who can participate
Age range
18 Years – 75 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
. Age from 18 to 75 years;
. ECOG performance status 0 or 1 before treatment;
. Metastatic melanoma or unresectable acral melanoma;
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
Overall response rate
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Trial details
NCT IDNCT03454919
SponsorPeking University Cancer Hospital & Institute
. Previous or current administration of any kind of CDK4/6 inhibitors;
. Administration of any other anti-tumor therapy (including but not limited to radiotherapy, chemotherapy, endocrinal therapy, surgery, molecular targeted therapy, immunotherapy or biological therapy) 4 weeks before inclusion; administration of mitocycin or nitrosamines 8 weeks before inclusion;