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Overcoming drug resistance in metastatic castration-resistant prostate cancer with novel combination of TGF-ß receptor inhibitor LY2157299 and enzalutamide: a randomized multi-site phase II study

Protocol Number:
Phase II
Channing Paller
Johns Hopkins Kimmel Cancer Center in Baltimore
Sibley Memorial Hospital
The purpose of the study is to compare progression-free survival in chemotherapy-naïve, post-abiraterone-treated metastatic castration-resistant prostate cancer patients treated with enzalutamide and LY2157299 versus enzalutamide alone.
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; metastatic disease radiographically documented by CT/MRI or bone scan. No abnormal laboratory test findings. Patient must be on continuous hormonal ablation with surgical or medical castration with baseline testosterone less than 50ng/dL. Prior treatment with Sipuleucel-T, Radium-223, abiraterone, ketoconazole, and/or Tak-700 within 2 weeks prior to the trial is allowed. Chemotherapy more than 6 months prior to this trial is allowed. Tumor biopsy of an accessible lesion at baseline and on treatment if the lesion can be biopsied is required. Prior treatment with enzalutamide, ARN-509, or galeterone is not allowed.
This is a multi-center, open-label, randomized study to evaluate the safety and clinical activity of enzalutamide in combination with LY2157299 versus enzalutamide alone. The patients will be assigned either to Arm 1 and treated with enzalutamide and LY2157299 or to Arm 2 and treated with enzalutamide alone. The patients will be seen in clinic every 4 weeks unless safety visits are required to be done sooner.

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