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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:
Phase II
Michael Carducci
Johns Hopkins Kimmel Cancer Center in Baltimore
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.
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.
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.
Last Update
03/05/2019 05:03 AM