hormone-refractory prostate cancer MedDRA version: 9.1 Level: LLT Classification code 10036909 Term: Prostate cancer metastatic
Conditions
Interventions
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:
Sponsors
Hybrigenics SA
Eligibility
Sex/Gender
Male
Inclusion criteria
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.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Prior chemotherapy except adjuvant chemotherapy; Radiotherapy within four weeks and/or more 30% of bone marrow; Surgery within 4 weeks; Radioisotopes within 8 weeks; Peripheral oedema, pleural effusion or pronounced abdominal distension (due to ascites); Hypersensibility to drug formulated with polysorbate-80; =grade 2 peripheral neuropathy; One or more contraindications to the use of corticosteroids; Current use of biphosphonates; Current use of digitalis; Thiazide diuretics within 7 days; Unwillingness or inability to stop treatment with magnesium-containing antacids, bile-resin binders, calcium supplement for the duration of the study; Treatment with any other anti-cancer therapy except LHRH agonists; Treatment with systemic corticosteroids used for reasons other than specified by the protocol which cannot be stopped; History of cancer related hypercalcemia and all diseases known to be associated with calcium disorders: hyperparathyroidism, sarcoidosis….; History of kidney stones in the last 5 years; Prior malignancy within the preceding 5 years except basal cell skin cancer and prostate cancer; History of congestive heart failure or angina pectoris even if it is medically controlled, uncontrolled hypertension or arrhythmia; Active infection; Uncontrolled pain; Concurrent treatment with other experimental drugs; Patients with a mental deficiency preventing proper understanding of trial protocol requirements; Prior entry into this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the maximum tolerated dose (MTD) of oral administration of inecalcitol in combination with standard docetaxel prednisone regimen in HRPC patients. ;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. ;Primary end point(s): Blood calcium level | — |
Countries
France
Outcome results
None listed