Evaluation of Safety of Cabazitaxel (Jevtana) in Patients With Metastatic Hormone Refractory Prostate Cancer

Study Overview
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Brief Summary
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Primary Objective: To evaluate the safety of cabazitaxel (Jevtana) in patients with metastatic hormone refractory prostate cancer Secondary Objectives: To describe the use of cabazitaxel (Jevtana) in combination with oral prednisolone for the treatment of patients with metastatic Hormone Refractory Prostate Cancer To describe patient profile in terms of demography, disease characteristics and prior treatment history To describe efficacy outcomes: radiological response (if available) using Recist criteria V 1.1 and Prostate Specific Antigen (PSA) response

Detailed Description
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The study consists of: a screening phase (maximum length of 7-day). a treatment phase with 21-day study treatment cycles. Patients continue to receive treatment until disease progression , death, unacceptable toxicity, investigator's decision or withdrawal of consent. a 30-day follow-up visit after the last dose of study medication.

Official Title
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Multicentre, Single Arm, Open Label, Non Controlled Phase IV Clinical Trial to Evaluate Safety of Cabazitaxel (Jevtana) in Combination With Oral Prednisone (or Prednisolone) for the Treatment of Patients With Metastatic Hormone Refractory Prostate Cancer Previously Treated With a Docetaxel-containing Regimen

Conditions
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Prostate Cancer Metastatic

Intervention / Treatment
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* Drug: CABAZITAXEL XRP6258
* Drug: Prednisone
* Drug: Prednisolone


Participation Criteria
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Eligibility Criteria
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Inclusion criteria : Metastatic hormone refractory prostate cancer (mHRPC) previously treated with a docetaxel-containing regimen Disease Progression during or after docetaxel-containing regimen for mHRPC Surgical or medical castration Patient is ≥ 18 years and ≤ 75 years of age Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 Adequate bone marrow, liver, and renal function: Neutrophils> 1500 /mm3; Hemoglobin > 10 g/dL; Platelets > 100 x109/L; Bilirubin < Upper Normal Limit (ULN); Serum Glutamate Oxaloacetate Transaminase (Aspartate Aminotransferase)/SGOT (AST) < 1.5xULN; Serum Glutamate Pyruvate Transaminase (Alanine Aminotransferase)/SGPT (ALT) < 1.5xULN; Creatinine < 1.5xULN. In case of creatinine > 1.0 x ULN and < or = 1.5 x ULN, calculated creatinine clearance according to CKD-EPI formula should be > or = 60 ml/min. Written informed consent must be obtained prior to any study related procedures Exclusion criteria: Prior radiotherapy to ≥ 40% of bone marrow Previous treatment with cabazitaxel (Jevtana®) Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrollment Active grade ≥2 peripheral neuropathy Active grade ≥2 stomatitis Active infection requiring systemic antibiotic or anti-fungal medication Active cancer (other than mHRPC) including prior malignancy from which the patient has been disease-free for ≤5 years Known brain or leptomeningeal involvement History of severe hypersensitivity reaction (≥grade 3) to docetaxel History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs History of severe hypersensitivity reaction (≥grade 3) or intolerance to prednisone or prednisolone Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus) Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a 2 weeks wash-out period is necessary for patients who are already on these treatments). Participation in any other clinical trial with any investigational drug Patient with reproductive potential not implementing accepted and effective method of contraception 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: 18 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: Cabazitaxel<br>Cabazitaxel 25 mg/m² intravenously every 3 weeks, in combination with oral prednisone or prednisolone 10 mg daily | Drug: CABAZITAXEL XRP6258<br>* Pharmaceutical form:Solution Route of administration: Intravenous<br>Drug: Prednisone<br>* Pharmaceutical form:Tablet Route of administration: Oral<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 |
| --- | --- | --- |
| Number of patients with Related Serious Adverse Events |  | up to13 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of use of cabazitaxel in terms of treatment duration, number of cycles, dose modifications |  | up to 13 months | 
| Radiological overall response (if radiological tumor assessment done) using Recist criteria |  | up to 13 months | 
| Number of patients with at least 50% decrease in PSA |  | up to 13 months |