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



Status:Terminated
Healthy:No
Age Range:18 - Any
Updated:1/12/2019
Start Date:September 3, 2014
End Date:November 6, 2014

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PHASE 1/2 STUDY OF PF-03084014 IN COMBINATION WITH GEMCITABINE AND NAB-PACLITAXEL IN PATIENTS WITH PREVIOUSLY UNTREATED METASTATIC PANCREATIC DUCTAL ADENOCARCINOMA

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.


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
5
sites
60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Aurora, Colorado 80045
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Aurora, Colorado 80045
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