Clinical Trial Details

NCT ID: NCT02501902
Date Last Changed: September 28, 2017

Overview

Research Study Summary

A Phase 1 clinical study for patients with Metastatic Pancreatic Ductal Adenocarcinoma, mPDAC

Research Study Title

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

Purpose

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.

To Learn more

Recruitment Details

Phase
1
Gender
All
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Pfizer
Duration
34 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years and up

Inclusion Criteria:

  • Histologically or cytologically-confirmed metastatic pancreatic ductal adenocarcinoma.

  • Availability of a tumor tissue specimen. If no archived tumor tissue is available, then a de novo biopsy is required for patient participation.

  • Karnofsky Performance Status 70 or greater.

  • Adequate Bone Marrow, Renal, and Liver Function.

Exclusion Criteria:

  • Prior treatment with a CDK 4/6 inhibitor.

  • Prior treatment with nab-P for the treatment of metastatic disease.

  • Patients with known CNS metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth.

  • Diagnosis of any other malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.

  • QTc > 480 msec, or family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes.

  • Uncontrolled electrolyte disorders.

  • Cardiac or pulmonary disorders within 6 months of enrollment.

  • Known human immunodeficiency virus infection.

  • History of interstitial lung disease or pneumonitis.

  • Other severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation.

  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to nab-P.

  • Difficulty swallowing capsules or requirement for a feeding tube.

  • Previous high-dose chemotherapy requiring stem cell rescue.

  • Pregnant female patients; breastfeeding female patients; male patients with partners currently pregnant.

  • Active inflammatory or other gastrointestinal disease,

  • Active bleeding disorder in the past 6 months.

  • Patients treated within the last 7 days prior to the start of IP with strong/moderate CYP3A4 inhibitors, strong/moderate CYP3A4 inducers, CYP2C8 inhibitors, strong/moderate CYP2C8 inducers, or drugs that are known to prolong the QT interval.

Site Locations (27)

Country State City Zip Facility and Contact
United States Arizona Scottsdale 85258 Scottsdale Healthcare Hospitals DBA HonorHealth
United States Arizona Scottsdale 85258 Virginia G. Piper Cancer Pharmacy
United States California La Jolla 92037-0845 UC San Diego Medical Center - La Jolla (Thornton Hospital)
United States California La Jolla 92037-0845 UC San Diego Moores Cancer Center - Investigational Drug Services (Drug Shipment)
United States California La Jolla 92093 UC San Diego Moores Cancer Center
United States California San Diego 92103 UC San Diego Medical Center - Hillcrest
United States Colorado Aurora 80045 Drug Shipment Address: Anschutz Cancer Pavilion
United States Colorado Aurora 80045 University of Colorado Cancer Center
United States Colorado Aurora 80045 University of Colorado Denver, CTO (CTRC)
United States Maryland Baltimore 21231-2410 Oncology Investigational Drug Services (Drug Shipment Only)
United States Maryland Baltimore 21231 The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
United States Maryland Baltimore 21287 Johns Hopkins Hospital
United States Massachusetts Boston 02215 Beth Israel Deaconess Medical Center
United States Massachusetts Boston 02215 Beth Isreal Deaconess Medical Center
United States Missouri Creve Coeur 63141 Siteman Cancer Center - West County
United States Missouri Saint Louis 63110 Barnes-Jewish Hospital
United States Missouri Saint Louis 63110 Washington University Infusion Center Pharmacy
United States Missouri Saint Louis 63110 Washington University School of Medicine
United States Missouri Saint Louis 63129 Siteman Cancer Center - South County
United States Missouri Saint Peters 63376 Siteman Cancer Center
United States Utah Salt Lake City 84112 University of Utah, Huntsman Cancer Hospital
United States Utah Salt Lake City 84112 University of Utah, Huntsman Cancer Institute
Spain Madrid Fuenlabrada 28942 Hospital Universitario de Fuenlabrada. Unidad de Farmacia (Only Drug Shipment)
Spain Madrid Fuenlabrada 28942 Hospital Universitario Fuenlabrada
Spain Barcelona 08035 Hospital Universitari Vall D'Hebron
Spain Madrid 28041 Hospital Universitario 12 de Octubre Servicio de Farmacia
Spain Madrid 28041 Hospital Universitario 12 de Octubre

Contact

Pfizer CT.gov Call Center
1-800-718-1021
E-mail:

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