drugset / Trial / NCT02640534

Investigation of Metformin in Patients With Castration Resistant Prostate Cancer in Combination With Enzalutamide vs. Enzalutamide Alone

NCT02640534 ↗

Phase 2 Terminated 169 enrolled Swiss Cancer Institute
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this trial is to test if the combination of enzalutamide and metformin in patients with castration resistant prostate cancer CRPC progressing on androgen deprivation therapy ADT is more effective compared to enzalutamide alone. The half of the patients will receive the experimental treatment combination, enzalutamide and metformin, while the other half will receive enzalutamide alone.

Timeline

Start
2016-06-10
Primary completion
2022-07-01
Completion
2023-03-16

Outcome

Outcome not reported

Stopped: “The decision is based on the fact that with the current follow up of around 10 years, the relevant secondary endpoints can adequately be addressed according to protocol. The addition of follow up data will not significantly impact these results.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Enzalutamide Other / unclassified 160 mg —
Subject Metformin Small molecule 850 mg —

Indications