NCT02138383

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

A Phase I Trial With Cohort Expansion of Enzalutamide in Combination With Gemcitabine and Nab-Paclitaxel for the Treatment of Advanced Pancreatic Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to find out the dose of enzalutamide that can be safely given with gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer. Researchers also want to find out the side effects of these drugs when given together. This study will help in finding out the effect on tumor of the combination of enzalutamide, gemcitabine and nab-paclitaxel. 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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-05-22
• Primary completion: 2016-12-15
• Completion: 2019-10-07
• First posted: 2014-05-14
• Last updated: 2021-08-17

Locations

1 site across 1 country: United States