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 |
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.
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
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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