Early Access to Cabazitaxel in Patients With Metastatic Hormone Refractory Prostate Cancer Previously Treated With a Docetaxel-containing Regimen

Study Overview
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Brief Summary
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The purpose of this study is to allow patients similar to that evaluated in the TROPIC trial (NCT00417079), and Investigators access to cabazitaxel for the management of metastatic Hormone Refractory Prostate Cancer (mHRPC) in those patients who have progressed during or after docetaxel and to document the overall safety of cabazitaxel in these patients. Please note that in each country, patient recruitment will end when cabazitaxel becomes commercially available.

Official Title
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Multicentre, Single-arm, Open Label Clinical Trial Intended to Provide Early Access to Cabazitaxel in Patients With Metastatic Hormone Refractory Prostate Cancer Previously Treated With a Docetaxel-containing Regimen and to Document Safety of Cabazitaxel in These Patients

Conditions
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Prostate Cancer Metastatic

Intervention / Treatment
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* Drug: CABAZITAXEL


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 Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0-2 Life-expectancy ≥3 months Adequate bone marrow, liver, and renal function: Neutrophils> 1500 /mm3; Hemoglobin > 10 g/dL; Platelets > 100 x109/L; Bilirubin < ULN; SGOT (AST) < 1.5xULN; SGPT (ALT) < 1.5xULN; Creatinine < 1.5xULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance < 60 mL/min should be excluded. Exclusion criteria: Prior radiotherapy to ≥ 40% of bone marrow Prior radionuclide therapy (samarium-153, strontium-89, P-32…) 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 (except superficial basal cell skin cancer) 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 cardiac arrhythmias, angina pectoris, hypertension or diabetes mellitus). History of congestive heart failure (NYHA III or IV) or myocardial infarction within last 6 months is also not allowed. Concurrent or planned treatment with potent inhibitors or inducers of cytochrome P450 3A4/5 Participation in a 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<br>* Pharmaceutical form: Concentrate For Solution For Infusion Route of administration: Intravenous<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To provide early access to cabazitaxel in patients with metastatic hormone refractory prostate cancer previously treated with a docetaxel-containing regimen |  | Up to 30 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To document safety of cabazitaxel in these patients |  | Up to 35 weeks |