Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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.
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.
Clareo Health | Early Access to Cabazitaxel in Patients With Metastatic Hormone Refractory Prostate Cancer Previously Treated With a Docetaxel-containing Regimen
