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A multicenter phase IIb trial to evaluate the efficacy and tolerability of ModraDoc006/r in patients with metastatic castration-resistant prostate cancer (mCRPC), suitable for treatment with a taxane

Journal of Clinical Oncology Feb 29, 2020

Vaishampayan UN, De Wit EJ, Shore ND, et al. - In order to determine the objective response rate (ORR), and additionally PSA response, PSA-PFS, time to skeletal related events and progression, duration of response, disease control rate and safety of ModraDoc006/r [oral combination of ModraDoc006 (oral tablet formulation of docetaxel) and ritonavir (/r; an inhibitor of cytochrome p450 3A4 and P-glycoprotein)] bi-daily QW vs docetaxel IV 75 mg/m2 Q3W in mCRPC pts with measurable disease per RECIST 1.1, suitable for docetaxel therapy, researchers have planned an open label 1:1 randomized phase 2b trial, given a phase Ib trial in mCRPC pts has already established safety and preliminary efficacy of ModraDoc006/r. No previous therapy with taxanes is allowed. The eligible patients are given thirty (30) mg ModraDoc006 combined with 200 mg /r in morning and 20 mg ModraDoc006 with 100 mg /r in evening on days 1, 8 and 15 of a 21 day cycle. 5 mg oral prednisone twice daily will be given to all patients. Therapy is continued until progression, unacceptable toxicity or patient desire. They will record patient-reported outcomes and health-related quality of life with treatment satisfaction and FACT-P questionnaires. Experts anticipated that the effectiveness of ModraDoc006/r will be at least equal to that of docetaxel IV. A sample size of 50 evaluable pts per arm will assess an estimated ORR of 25% in each arm, with a 5% two-sided alpha and power of 83.7%. Overall, it has been concluded that ModraDoc006/r provides convenience of oral administration, has reduced myelosuppressive toxicity and potential improved efficacy over IV docetaxel, and with all these qualities, it signifies progress in prostate cancer therapeutics.
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