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NCT02334527 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by UNC Lineberger Comprehensive Cancer Center.

Terminated
Registry status
Phase 2
Development phase
12
Enrollment target

NCT02334527: Clinical Trial Phase 2 study, sponsored by UNC Lineberger Comprehensive Cancer Center.

NCT02334527 is a Phase 2 study that was terminated before completion, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02334527, a Phase 2 study, was terminated before completion, sponsored by UNC Lineberger Comprehensive Cancer Center.

TERMINATED
Registry status
Phase 2
Development phase
12 participants
Enrollment target

Study 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.

Primary Outcome

Estimate progression free survival (PFS) at 4 months in patients with metastatic urothelial cancer (UC) who have progressed after first-line chemotherapy. PFS is defined as the percent of patients who are alive and free from progression at 4 months.

Interventions

  • DRUG Palbociclib

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2015-03-17
Est. Completion 2017-09-28
Phase Phase 2

Why NCT02334527 stopped before completion

NCT02334527 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).

The record links to 0 conditions, and to 1 intervention - of which Palbociclib is the first listed.

NCT02334527 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02334527 about?

NCT02334527 is a clinical study titled "Phase II Trial of Palbociclib in Patients With Metastatic Urothelial Cancer After Failure of First-Line Chemotherapy". 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.

What is the current status of trial NCT02334527?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2015-03-17. Estimated completion is 2017-09-28.

What interventions are being tested in trial NCT02334527?

The interventions under investigation include: Palbociclib (DRUG).

Who is sponsoring clinical trial NCT02334527?

This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02334527's enrollment target sits among peer trials

12 1948th of 2000 higher than 34 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02334527, the US trial registry maintained by the National Library of Medicine. NCT02334527 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.