Status:
COMPLETED
Early Access to Cabazitaxel in Patients With Metastatic Hormone Refractory Prostate Cancer Previously Treated With a Docetaxel-containing Regimen
Lead Sponsor:
Sanofi
Conditions:
Prostate Cancer Metastatic
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
984 Patients enrolled
Trial Details
Trial ID
NCT01254279
Start Date
December 1 2010
End Date
December 1 2014
Last Update
January 21 2015
Active Locations (165)
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1
Investigational Site Number 036004
Box Hill, Australia, 3128
2
Investigational Site Number 036020
Campbelltown, Australia, 2560
3
Investigational Site Number 036001
Camperdown, Australia, 2050
4
Investigational Site Number 036002
Camperdown, Australia, 2050