Dose-Escalation Study Of Palbociclib + Nab-Paclitaxel In mPDAC

Completed · Phase 1

Conditions studied: Metastatic Pancreatic Ductal Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT02501902

Run by

Pfizer

People needed

76

Starts

2015-11-23

Expected to finish

2018-12-27

Last updated by the study team

2021-04-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Scottsdale Healthcare Hospitals DBA HonorHealth — Scottsdale, Arizona, United States
• Virginia G. Piper Cancer Pharmacy — Scottsdale, Arizona, United States
• UC San Diego Medical Center - La Jolla (Thornton Hospital) — La Jolla, California, United States
• UC San Diego Moores Cancer Center - Investigational Drug Services — La Jolla, California, United States
• UC San Diego Moores Cancer Center — La Jolla, California, United States
• UC San Diego Medical Center - Hillcrest — San Diego, California, United States
• Anschutz Cancer Pavilion — Aurora, Colorado, United States
• University of Colorado Cancer Center — Aurora, Colorado, United States
• University of Colorado Denver, CTO (CTRC) — Aurora, Colorado, United States
• University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP) — Aurora, Colorado, United States
• University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP) — Aurora, Colorado, United States
• The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Siteman Cancer Center — City of Saint Peters, Missouri, United States
• Siteman Cancer Center - West County — Creve Coeur, Missouri, United States
• Barnes-Jewish Hospital — St Louis, Missouri, United States
• Washington University Infusion Center Pharmacy — St Louis, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Siteman Cancer Center - South County — St Louis, Missouri, United States
• University of Utah, Huntsman Cancer Hospital — Salt Lake City, Utah, United States
• University of Utah, Huntsman Cancer Institute — Salt Lake City, Utah, United States
• Hospital Universitario de Fuenlabrada. Unidad de Farmacia — Fuenlabrada, Madrid, Spain
• Hospital Universitario Fuenlabrada — Fuenlabrada, Madrid, Spain
• Hospital Universitari Vall D'Hebron, Servicio de Oncología Médica — Barcelona, Spain
• Hospital Universitario 12 de Octubre Servicio de Farmacia — Madrid, Spain

Full record on ClinicalTrials.gov

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