Efficacy of Palbociclib in Advanced Acral Melanoma With Cell Cycle Gene Aberrations
Status:
Unknown status
Trial end date:
2020-06-30
Target enrollment:
Participant gender:
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.