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

Phase 3

Completed

• Conditions: Health Condition 1: C61- Malignant neoplasm of prostateHealth Condition 2: null- Mestatic Hormone Refractory Prostate Cancer

• Registration Number: CTRI/2011/06/001809
• Lead Sponsor: SanofiSynthelabo India Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 808

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To provide early access to cabazitaxel in patients with metastatic hormone refractory prostate cancer previously treated with a docetaxel-containing regimenTimepoint: up to 30 weeks

Secondary Outcome Measures

Name	Time	Method
To document safety of cabazitaxel in these patientsTimepoint: 35 weeks