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

PHASE2TerminatedINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

September 3, 2014

Primary Completion Date

November 6, 2014

Study Completion Date

November 6, 2014

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.

Trial Locations (5)

14642

University of Rochester Investigational Drug Pharmacy, Rochester

University of Rochester, Rochester

80045

Anschutz Inpatient Pavilion, Aurora

University of Colorado Cancer Center, Aurora

University of Colorado Denver, CTO (CTRC), Aurora

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Academic GI Cancer Consortium (AGICC)

OTHER

lead

Pfizer

INDUSTRY