E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
hormone-refractory prostate cancer |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036909 |
E.1.2 | Term | Prostate cancer metastatic |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine the maximum tolerated dose (MTD) of oral administration of inecalcitol in combination with standard docetaxel prednisone regimen in HRPC patients.
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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; |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |