MedTrace Logo

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

NCT02109445 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2019-01-10

Study results available
· View outcomes & findings →

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.

Conditions

  • Metastatic Cancer Pancreas

Interventions

DRUG

PF-03084014

Tablets, orally administered twice daily on a continuous dosing schedule in 28 days cycles. Doses: 100 -150 mg BID

DRUG

Gemcitabine

Intravenously administered on Days 1, 8, 15 in 28 days cycles at the dose of 1000 mg/m2.

DRUG

Nab-paclitaxel

Intravenously administered on Days 1, 8, 15 in 28 days cycles at the dose of 125 mg/m2.

DRUG

PF-03084014

Tablets, orally administered twice daily on a continuous dosing schedule in 28 days cycles. Phase 2 dose will be the recommended phase 2 dose defined in phase 1.

DRUG

Gemcitabine

Intravenously administered on Days 1, 8, 15 in 28 days cycles at the dose of 1000 mg/m2.

DRUG

Nab-paclitaxel

Intravenously administered on Days 1, 8, 15 in 28 days cycles at the dose of 125 mg/m2.

DRUG

Gemcitabine

Intravenously administered on Days 1, 8, 15 in 28 days cycles at the dose of 1000 mg/m2.

DRUG

Nab-paclitaxel

Intravenously administered on Days 1, 8, 15 in 28 days cycles at the dose of 125 mg/m2.

Sponsors & Collaborators

  • Academic GI Cancer Consortium (AGICC)

    collaborator OTHER

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-03
Primary Completion
2014-11-06
Completion
2014-11-06

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02109445 on ClinicalTrials.gov