Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started Nov 2015

Typical duration for phase_1

Geographic Reach

2 countries

26 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.1 years study duration

First Submitted

Initial submission to the registry

July 14, 2015

Completed

3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2015

Completed

4 months until next milestone

Study Start

First participant enrolled

November 23, 2015

Completed

2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2018

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2018

Completed

2.3 years until next milestone

Results Posted

Study results publicly available

April 6, 2021

Completed

Last Updated

April 6, 2021

Status Verified

March 1, 2021

Enrollment Period

2.9 years

First QC Date

July 14, 2015

Results QC Date

October 4, 2019

Last Update Submit

March 10, 2021

Conditions

Metastatic Pancreatic Ductal Adenocarcinoma

Keywords

Ibrance, palbociclib, Abraxane, nab-paclitaxel, pancreas,

Outcome Measures

Primary Outcomes (1)

Number of Participants With Dose Limiting Toxicities
Adverse events (AEs) considered as dose limiting toxicities (DLTs) included: hematologic: Grade 4 neutropenia lasting \>4 days; Febrile neutropenia (defined as neutropenia Grade\>=3 \[absolute neutrophil count {ANC}\<1000 cells/cubic millimeter {mm\^3}\] and a body temperature \>=38.5 \[degrees centigrade\]℃) requiring antibiotic or antifungal treatment; any Grade 4 thrombocytopenia (\<25000/mm\^3 or 25.0\*10\^9/\[liter\]L). Non-hematologic: Grade \>=3 toxicities, except those that had not been maximally treated (eg, nausea, vomiting, diarrhea). Any AE that caused a palbociclib treatment interruption of greater than 7 consecutive days or caused any combination of interruption/reduction for \>=14 days. Any AE that caused omission or reduction of at least 2 of the 3 weekly doses of nab-P.
From Day 1 until pre-dose Cycle 2 Day 1

Secondary Outcomes (27)

Number of Participants With Adverse Events
From the signing of informed consent up to 56 days after the last administration of the investigational product, or 365 days from the first dose of investigational product, whichever is later
Number of Participants With Laboratory Abnormalities
From screening to the end of treatment/withdrawal visit (up to 63 days from last dose of investigational product).
Number of Participants With Vital Signs Data Meeting Pre-specified Criteria
From screening to the end of treatment/withdrawal visit (up to 63 days from last dose of investigational product).
Number of Participants With 20% Maximum Reduction From Baseline in Ca19-9
From screening to the end of treatment/withdrawal visit (up to 63 days from last dose of investigational product).
Number of Participants With 50% Maximum Reduction From Baseline in Ca19-9
From screening to the end of treatment/withdrawal visit (up to 63 days from last dose of investigational product).
+22 more secondary outcomes

Study Arms (1)

Palbociclib + Nab-Paclitaxel

EXPERIMENTAL

Palbociclib oral dosing on Days 1 to 21 of each 28-day cycle. Nab-paclitaxel IV dosing on Days -2, 6, and 13 of Cycle 1, and on Days 1, 8, and 15 of subsequent cycles.

Drug: PalbociclibDrug: Nab-Paclitaxel

Interventions

PalbociclibDRUG

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

Also known as: Ibrance

Palbociclib + Nab-Paclitaxel

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.

Also known as: Abraxane

Palbociclib + Nab-Paclitaxel

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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,
+2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Pfizerlead
Celgenecollaborator

Study Sites (26)

Scottsdale Healthcare Hospitals DBA HonorHealth

Scottsdale, Arizona, 85258, United States

Location

Virginia G. Piper Cancer Pharmacy

Scottsdale, Arizona, 85258, United States

Location

UC San Diego Medical Center - La Jolla (Thornton Hospital)

La Jolla, California, 92037-0845, United States

Location

UC San Diego Moores Cancer Center - Investigational Drug Services

La Jolla, California, 92037-0845, United States

Location

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

UC San Diego Medical Center - Hillcrest

San Diego, California, 92103, United States

Location

Anschutz Cancer Pavilion