At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 76 enrolled

Drug / intervention

Palbociclib +1 moredrug

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02501902

NCT02501902Phase 1Completed

Compare CT.gov

AN OPEN-LABEL PHASE IB STUDY OF PALBOCICLIB (ORAL CDK 4/6 INHIBITOR) PLUS ABRAXANE (REGISTERED) (NAB-PACLITAXEL) IN PATIENTS WITH METASTATIC PANCREATIC DUCTAL ADENOCARCINOMA

Pfizer·interventional·Posted Jul 17, 2015·Updated Apr 6, 2021

In Brief

A Phase 1 clinical trial evaluating Palbociclib and Nab-Paclitaxel for Metastatic Pancreatic Ductal Adenocarcinoma. Completed, enrolled 76 participants across 26 sites in 2 countries.

Detailed Summary

This is a Phase 1, open label, multi center, multiple dose, dose escalation, safety, pharmacokinetic and pharmacodynamic study of palbociclib in combination with nab-P, in sequential cohorts of adult patients with mPDAC, with MTD expansion cohort(s). Approximately 30-60 patients are expected to be enrolled in the overall study.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsMetastatic Pancreatic Ductal Adenocarcinoma

CountriesSpain, United States

CollaboratorsCelgene

Timeline

Phase 1CompletedFinished

20162017201820192020202120222023202420252026

First PostedJul 2015

Enrollment StartNov 2015

Primary CompletionOct 2018

Study CompletionDec 2018

TodayJul 2026

First PostedJul 17, 2015

Enrollment StartNov 23, 2015

Primary CompletionOct 10, 2018

Study CompletionDec 27, 2018

TodayJul 2, 2026

Enrollment to primary: 2.9 yearsPosted 11.0 years ago

Interventions

Palbociclibdrug

Palbociclib oral dosing on Days 1 to 21 of each 28-day cycle.

Nab-Paclitaxeldrug

Nab-paclitaxel IV dosing on Days -2, 6, and 13 of Cycle 1, and on Days 1, 8, and 15 of subsequent cycles.