Dose finding Phase 2a Study of Inecalcitol in Combination with Standard Docetaxel Prednisone Regimen in Hormone-Refractory Prostate Cancer

INTERVENTION: Product Name: inecalcitol Product Code: HBX 34,701 Pharmaceutical Form: Capsule, soft INN or Proposed INN: inecalcitol CAS Number: 163217‐09‐2 Current Sponsor code: HBX 34,701 Other descriptive name: TX 522 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 10‐40‐ CONDITION: hormone‐refractory prostate cancer ; MedDRA version: 9.1 Level: LLT Classification code 10036909 Term: Prostate cancer metastatic PRIMARY OUTCOME: Main Objective: To determine the maximum tolerated dose (MTD) of oral administration of inecalcitol in combination with standard docetaxel prednisone regimen in HRPC patients.; ; Primary end point(s): Blood calcium level Secondary Objective: To assess the safety profile of inecalcitol when used in combination with docetaxel and prednisone;; To provide preliminary assessment of efficacy;; To assess pharmacokinetic parameters of inecalcitol; ; To determine the pharmacokinetic profile of docetaxel when used in combination with inecalcitol. ; INCLUSION CRITERIA: Histopathologically or cytologically proven adenocarcinoma of the prostate;Hormone‐refractory prostate cancer defined by documented disease progression [Progression of pre‐existent lesion or new metastatic lesion or increase in serum PSA levels (3 measurements at an interval of at least 7 days)] despite standard hormonal management including antiandrogen withdrawal since at least 4 weeks (6 weeks in the case of bicalutamide); Normal cardiac function : Left ventricular ejection fraction (LVEF) = 50% as determined by echocardiograph; Hemoglobin =11dg/dL; Platelets = 100 x 109 L; Absolute neutrophil count = 1.5 x 109 L; Total Bilirubin = ULN; AST/SGOT= 1.5 x ULN; ALT/SGPT = 1.5 x ULN; Alkaline phosphatases = 2.5 x ULN except in patients with bone metastasis; Corrected Blood calcium = ULN; Serum clearance of creatinine = ULN; urinary calcium (Ca/Creat) = ULN; ECOG score 0 – 2; Are the trial subjects under 18? no Number of subjects for this age range: F.1