Study Of PF-03084014 In Combination With Gemcitabine And Nab-Paclitaxel In Patients With Metastatic Pancreatic Adenocarcinoma Not Previously Treated With Anticancer Therapies

Stopped early · Phase 2

Conditions studied: Metastatic Cancer Pancreas

In brief

This study consists of a Phase 1b portion aimed to determine the maximum tolerated dose and the safety profile of PF-03084014 in combination with gemcitabine and nab-paclitaxel followed by a Phase 2 portion to evaluate the efficacy of the triple combination in terms of overall survival in patients with metastatic pancreatic ductal adenocarcinoma not previously treated with anticancer therapies.

Key facts

Study ID

NCT02109445

Run by

Pfizer

People needed

3

Starts

2014-09-03

Expected to finish

2014-11-06

Last updated by the study team

2019-01-10

Who can join

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

You may qualify if…

• Histologically or cytologically diagnosis of metastatic ductal adenocarcinoma of the pancreas.
• No prior radiotherapy, surgery chemotherapy or investigational therapy for metastatic disease. Prior adjuvant therapy with 5-FU or gemcitabine (± gemcitabine post radiation) administered as radiosensitizer allowed, provided at least 6 months have elapsed between the last dose and study registration
• Tumor tissue available (Archival 6 months old or de novo biopsy)
• Measurable disease as per RECIST 1.1
• Performance Status (ECOG) 0 or 1

You may not qualify if…

• Symptomatic brain metastases requiring steroids
• Prior therapy with gamma secretase inhibitors or other Notch pathway inhibitor
• Major surgery within 4 weeks of registration in the current study
• Known hypersensitivity to gemcitabine or nab-paclitaxel or any of the excipients
• Current or anticipated need for food or drugs that are strong/moderate CYP3A4 inhibitors or inducers
• Diagnosis of any second malignancy within 3 years prior to registration

Where it is running

• Anschutz Inpatient 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 Rochester Investigational Drug Pharmacy — Rochester, New York, United States
• University of Rochester — Rochester, New York, United States

Full record on ClinicalTrials.gov

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