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

NCT03454919 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-03-06

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Kiang Wu Hospital

    collaborator OTHER

  • Peking University Cancer Hospital & Institute

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-30
Primary Completion
2019-12-31
Completion
2020-06-30
FDA Drug
Yes

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03454919 on ClinicalTrials.gov