NCT03454919

Efficacy of Palbociclib in Advanced Acral Melanoma With Cell Cycle Gene Aberrations

A Phase II Clinical Study on Efficacy of Palbociclib in Advanced Acral Melanoma With Cell Cycle Gene Aberrations

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is to evaluate efficacy of palbociclib in advanced acral melanoma patients with gene aberrations in cell cycle pathways \[including CDK4 amplification and/or CCND1 amplification and/or P16 (CDKN2A) loss\].

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	Palbociclib	Drug: palbociclib; ibrance; Pfizer Inc，New York，NY Schedule: Recommended initial dosage 125mg/d，3 weeks on, 1 week off. If grade 3 or 4 adverse events occur during treatment，dosage could be reduced to 100mg/d, even 75mg/d. Duration: till disease progression or drug intolerance.

Timeline

• Start date: 2018-03-30
• Primary completion: 2019-12-31
• Completion: 2020-06-30
• First posted: 2018-03-06
• Last updated: 2018-03-06

Regulatory

• FDA-regulated drug study