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

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Metastatic Cancer Pancreas

Treatments: Drug: Nab-paclitaxel; Drug: Gemcitabine; Drug: PF-03084014

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02109445

A8641019

2013-005574-21 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

3 participants in 3 patient groups

Phase 1

Experimental group

Description:

PF-03084014 in combination with gemcitabine and nab-paclitaxel

Treatment:

Drug: Nab-paclitaxel

Drug: Nab-paclitaxel

Drug: Gemcitabine

Drug: Nab-paclitaxel

Drug: Gemcitabine

Drug: Gemcitabine

Drug: PF-03084014

Drug: PF-03084014

Phase 2 Arm A

Experimental group

Description:

PF-03084014 in combination with gemcitabine and nab-paclitaxel

Treatment:

Drug: Nab-paclitaxel

Drug: Nab-paclitaxel

Drug: Gemcitabine

Drug: Nab-paclitaxel

Drug: Gemcitabine

Drug: Gemcitabine

Drug: PF-03084014

Drug: PF-03084014

Phase 2 Arm B

Active Comparator group

Description:

Gemcitabine plus nab-Paclitaxel

Treatment:

Drug: Nab-paclitaxel

Drug: Nab-paclitaxel

Drug: Gemcitabine

Drug: Nab-paclitaxel

Drug: Gemcitabine

Drug: Gemcitabine