drugset / Trial / NCT02334527

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

NCT02334527 ↗

NaSingle-groupOpen-labelTreatment

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.

Timeline

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

Outcome

Outcome not reported

Stopped: “Data from first 12 subjects-primary endpoint not met. Data analysis underway.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Palbociclib Small molecule 125 mg Oral

Indications