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 - CABAZ

SanofiSynthelabo India Limited0 个研究点目标入组 808 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Main inclusion criteria:
•- Age ≥18 years
•- Metastatic Hormone Refractory Prostate Cancer 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
•- Signed written informed consent obtained prior to enrollment

•Main 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 non-melanoma 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 diabetes mellitus)
•- Concurrent or planned treatment with potent inhibitors or inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments)
•- Participation in a clinical trial with any investigational drug
•- Patient with reproductive potential not implementing accepted and effective method of contraception

发起方

SanofiSynthelabo India Limited