Enzalutamide in Combination With Gemcitabine and Nab-Paclitaxel for the Treatment of Advanced Pancreatic Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

May 22, 2014

Primary Completion Date

December 15, 2016

Study Completion Date

October 7, 2019

Conditions
Pancreatic Cancer
Interventions
DRUG

Enzalutamide

The starting dose of enzalutamide will be 80 mg (Level 1) daily, taken orally. The dose escalation schedule is a standard 3 + 3 design. In the first part of the study, different doses of enzalutamide will be tested. In the second part of the study, all patients will be started at the same dose of enzalutamide.

DRUG

Gemcitabine

The starting dose of gemcitabine will be 1000 mg/m\^2 administered intravenously on days 1, 8 and 15 of each cycle.

DRUG

Nab-paclitaxel

The starting dose of nab-paclitaxel will be 125 mg/m\^2 administered intravenously on days 1, 8 and 15 of each cycle.

Trial Locations (1)

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Astellas Pharma Inc

INDUSTRY

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER

NCT02138383 - Enzalutamide in Combination With Gemcitabine and Nab-Paclitaxel for the Treatment of Advanced Pancreatic Cancer | Biotech Hunter | Biotech Hunter