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

Last updated on March 14, 2019

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Study Location
Anschutz Inpatient Pavilion
Aurora, Colorado, 80045 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Cancer Pancreas
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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

NCT02109445
Pfizer
Terminated
Study Of PF-03084014 In Combination With Gemcitabine And Nab-Paclitaxel In Patients With Metastatic Pancreatic Adenocarcinoma Not Previously Treated With Anticancer Therapies

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