Dose Escalation Study With Cabazitaxel in Combination With Daily Prednisolone in Patients With Hormone Refractory Prostate Cancer

Study Overview
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Brief Summary
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Primary Objective: To assess the tolerability at global doses Secondary Objectives: Safety Pharmacokinetics Efficacy

Detailed Description
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The duration of screening within 28 days, treatment 3 weeks/cycle and follow-up 30 days after the last cabazitaxel administration.

Official Title
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An Open Label, Dose Escalation, Safety and Pharmacokinetics Phase I Study With Cabazitaxel Administered as a 1-hour Intravenous Infusion Every 3 Weeks in Combination With Daily Prednisolone in Patients With Hormone Refractory Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Cabazitaxel (XRP6258)
* Drug: prednisolone


Participation Criteria
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Eligibility Criteria
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Inclusion criteria : I 01. Diagnosis of histologically or cytologically proven prostate adenocarcinoma, that is refractory to hormone therapy (received prior castration by orchiectomy and/or internal medicine, and documented progression of disease or relapse) who has previously been treated with docetaxel. I 02. Signed informed consent prior to beginning protocol specific procedures. I 03. Patients with PSA >20 ng/mL at screening. Exclusion criteria: E 01. Age <20 and >74 E 02. ECOG performance status ≥2. E 03. Prior surgery ≤4 weeks of registration in the study. E 04. Active secondary cancer including prior malignancy from which the patient has been disease-free for ≤5 years (However, adequately treated superficial basal cell skin cancer before 4 weeks prior to registration can be eligible to the study) E 05. Inadequate organ function including: Neutrophils <2.0 x 109/L Platelets <100 x 109/L Hemoglobin <9.0 g/dL (transfusion prohibition within 14 days before registration) Creatinine >1.5 mg/dL. Total bilirubin >1.5 times the upper normal limits of the institutional norms ALT/AST >1.5 times the upper normal limits of the institutional norms E 06. Previous treatment with <225 mg/m2 cumulative dose of Taxotere® (or docetaxel). The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 73 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Patients will receive cabazitaxel as the dose of corresponded level 1-hour intravenous infusion every 3 weeks plus prednisolone 10 mg orally given daily: Dose Level Cabazitaxel Dose Level -1: 15 mg/m², Level 1: 20 mg/m², Level 2: 25 mg/m² | Drug: Cabazitaxel (XRP6258)<br>* Pharmaceutical form:solution Route of administration: intravenous<br>Drug: prednisolone<br>* Pharmaceutical form:tablet Route of administration: oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of maximum tolerated dose |  | up to 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with treatment emergent adverse events |  | up to 18 months | 
| Pharmakokinetic parameters of Cabazitaxel |  | up to 18 months | 
| Prostate Specific Antigen (PSA) Response |  | up to 18 months |