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Phase II Trial of Palbociclib in Patients With Metastatic Urothelial Cancer After Failure of First-Line Chemotherapy

NCT02334527 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-11-16

Study results available
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Summary

This multicenter phase II trial will evaluate palbociclib (PD-0332991) in patients with metastatic urothelial carcinoma (UC) with cyclin-dependent kinase inhibitor 2A (CDKN2A) (also referred to as p16) loss and positive Retinoblastoma (Rb) expression after failure of first-line chemotherapy.

Conditions

  • Metastatic Urothelial Carcinoma (UC)

Interventions

DRUG

Palbociclib

125 mg capsule will be taken once per day orally and continuously for 3 weeks followed by 1 week off.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Matthew I Milowsky, MD · UNC Lineberger Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-17
Primary Completion
2016-12-02
Completion
2017-09-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT02334527 on ClinicalTrials.gov