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PF-04136309 with Gemcitabine and Nab-Paclitaxel in Metastatic Pancreatic Cancer
NCT02732938Phase 2
Key facts
- Status
- Terminated
- Start
- May 2016
- Primary completion
- Sep 2017
- Countries
- 1
- Sponsor
- Pfizer
- Modality
- Small Molecules
- Drugs
- PF-04136309
- Conditions
- pancreatic ductal adenocarcinoma (PDAC)
01
Overview
Phase 2, randomised, double-blind trial of PF-04136309 in pancreatic ductal adenocarcinoma (PDAC), sponsored by Pfizer. Primary endpoints: Dose-Limiting Toxicities, Adverse Events at 1 year and 2 more. Started May 2016; status: terminated.
02
Design
- Study design
- RandomizedDouble-blind
03
Who it enrols
Patients with histologically proven metastatic pancreatic ductal adenocarcinoma who have not received prior therapy for metastatic disease, with ECOG PS 0-1 and adequate organ function.
04
Endpoints
Primary
Dose-Limiting Toxicities
Adverse Events
Laboratory Abnormalities
Progression Free Survival
Secondary
Maximum Observed Plasma Concentration
Time to Reach Maximum Observed Plasma Concentration
Area Under the Curve From Time Zero to End of Dosing Interval
Overall Survival
Objective Response Rate
Duration of Objective Response
Time to Progression
Pharmacodynamic Markers
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