Enzalutamide in Combination With Gemcitabine and Nab-Paclitaxel for the Treatment of Advanced Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT02138383|
Recruitment Status : Completed
First Posted : May 14, 2014
Last Update Posted : October 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Enzalutamide Drug: Gemcitabine Drug: Nab-paclitaxel||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial With Cohort Expansion of Enzalutamide in Combination With Gemcitabine and Nab-Paclitaxel for the Treatment of Advanced Pancreatic Cancer|
|Actual Study Start Date :||May 22, 2014|
|Actual Primary Completion Date :||December 15, 2016|
|Actual Study Completion Date :||October 7, 2019|
Experimental: Dose Escalation and Dose Expansion
Dose Escalation: To find the dose of enzalutamide that can be safely given with gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer.
Dose Expansion: To find the effect on tumor of the combination of enzalutamide, gemcitabine and nab-paclitaxel.
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.
The starting dose of gemcitabine will be 1000 mg/m^2 administered intravenously on days 1, 8 and 15 of each cycle.
The starting dose of nab-paclitaxel will be 125 mg/m^2 administered intravenously on days 1, 8 and 15 of each cycle.
- Maximum Tolerated Dose (MTD) [ Time Frame: Up to 18 months ]To determine the maximally tolerated dose (MTD) of enzalutamide in combination with gemcitabine and nab-paclitaxel in advanced pancreatic cancer.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138383
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Richard Kim, M.D.||H. Lee Moffitt Cancer Center and Research Institute|