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
• Trial end date: 2014-11-06
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Collaborators: Academic GI Cancer Consortium; Academic GI Cancer Consortium (AGICC)
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Paclitaxel

Criteria

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