Health Condition 1: Z854- Personal history of malignant neoplasm of genital organs Health Condition 2: null- Prostate Cancer
Conditions
Interventions
Intervention1: Cabazitaxel: Cabazitaxel 25 mg/m sq intravenously every 3 weeks. Each patient will be treated until disease progression, death
Intervention2: Prednisone: 10 mg daily
Orally
Control Inte
Sponsors
Sanofi Synthelabo India Ltd
Eligibility
Inclusion criteria
Inclusion criteria: • 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 • Patient is >= 18 years and This is not exhaustive list.
Exclusion criteria
Exclusion criteria: • Prior radiotherapy to >= 40% of bone marrow • Previous treatment with cabazitaxel (Jevtana) • 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 This is not exhaustive list.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with Related Serious Adverse EventsTimepoint: End of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Dose administration of cabazitaxel. Duration of exposure and total number of cycles received from the initiation of cabazitaxel therapy, dose modifications Radiological overall response using Recist criteria Number of patients with at least 50% decrease in PSA Timepoint: Through out the study | — |
Countries
India
Contacts
Public ContactMs Salini James
Sanofi Synthelabo India Limited
Outcome results
None listed