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Title:
A Phase 2 Non-randomized Open-label Study Examining the Effect of eFT508 in Patients with Advanced Castrate-resistant Prostate Cancer (CRPC) (eFT508-0009)
Protocol Number:
J1883
Phase:
Phase II
Physician:
Michael Carducci
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
The purpose of the study is to evaluate an investigational drug, called eFT508, and to see if it might be useful for treatment of men with advanced castrate-resistant prostate cancer in the future.
Eligibility:
Patient must meet all eligibility criteria to be enrolled in the study. Below is the portion of the study requirements: histologically or cytologically confirmed adenocarcinoma of the prostate. Patients must have PSA progression with prior treatment with abiraterone, enzalutamide, or apalutamide. No abnormal laboratory test findings; available tumor tissue (archival or fresh). Patients must be on continuous hormonal ablation with surgical or medical castration with baseline testosterone less than 50ng/dL. Prior treatment with chemotherapy, flutamide, dutasteride, finasteride, bicalutamide, or nilutamide is allowed. Prior treatment with any known MNK-1 or MNK-2 inhibitor is not allowed. Use of herbal products that may have hormonal anti-prostate cancer activity such as saw palmetto is not allowed on the trial. Patients with significant cardiac history and symptomatic will be excluded.
Treatment:
This is a multi-center, open-label, non-randomized study to examine the effect eFT508 in patients with advanced castrate-resistant prostate cancer. The patients will be treated with eFT508 twice a day orally approximately 12 hours apart on an empty stomach. For the first 2 cycles (8 weeks) the patients will be seen in the clinic frequently to assess the safety. Starting from Cycle 3 the patients will be seen in the clinic every 4 weeks unless safety visits are required to be done sooner.
Population:
Adult
Last Update
03/05/2019 05:03 AM