Enzalutamide Plus Everolimus in Men With Metastatic Castrate-Resistant Prostate Cancer

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: SCRI Development Innovations, LLC

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine the safety and efficacy of a novel combination of agents, enzalutamide and everolimus, for the treatment of patients with metastatic castrate-resistant prostate cancer who have never received prior chemotherapy, or who have previously received docetaxel chemotherapy and have progressive disease.

Research Team

John D. Hainsworth, MD

Principal Investigator

SCRI Development Innovations, LLC

Eligibility Criteria

Inclusion Criteria

ECOG of 0 to 2.

Adenocarcinoma of the prostate confirmed histologically.

Metastatic disease confirmed by biopsy or imaging studies.

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Treatment Details

Interventions

Enzalutamide (Hormone Therapy)
Everolimus (Targeted Therapy)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Everolimus and EnzalutamideExperimental Treatment2 Interventions

Dose Escalation Phase (18 patients): 3-6 patients will be treated at each dose level until the Maximum Tolerated Dose (MTD) is determined. * Everolimus: Orally (PO) once daily (dose to be determined; * Enzalutamide: 160mg (four 40mg capsules) PO continuous daily dosing. Dose Expansion Phase (23 patients): Everolimus and Enzalutamide to be administered using the MTD determined in the dose escalation phase.

Enzalutamide is already approved in Canada, Japan for the following indications: