Overview

Dose Escalation Study With Cabazitaxel in Combination With Daily Prednisolone in Patients With Hormone Refractory Prostate Cancer

Status:
Completed
Trial end date:
2014-11-01
Target enrollment:
0
Participant gender:
Male
Summary
Primary Objective: - To assess the tolerability at global doses Secondary Objectives: - Safety - Pharmacokinetics - Efficacy
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sanofi
Treatments:
Hormones
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Criteria
Inclusion criteria :

I 01. Diagnosis of histologically or cytologically proven prostate adenocarcinoma, that is
refractory to hormone therapy (received prior castration by orchiectomy and/or internal
medicine, and documented progression of disease or relapse) who has previously been treated
with docetaxel.

I 02. Signed informed consent prior to beginning protocol specific procedures.

I 03. Patients with PSA >20 ng/mL at screening.

Exclusion criteria:

E 01. Age <20 and >74

E 02. ECOG performance status ≥2.

E 03. Prior surgery ≤4 weeks of registration in the study.

E 04. Active secondary cancer including prior malignancy from which the patient has been
disease-free for ≤5 years (However, adequately treated superficial basal cell skin cancer
before 4 weeks prior to registration can be eligible to the study)

E 05. Inadequate organ function including:

Neutrophils <2.0 x 109/L Platelets <100 x 109/L Hemoglobin <9.0 g/dL (transfusion
prohibition within 14 days before registration) Creatinine >1.5 mg/dL. Total bilirubin >1.5
times the upper normal limits of the institutional norms ALT/AST >1.5 times the upper
normal limits of the institutional norms

E 06. Previous treatment with <225 mg/m2 cumulative dose of Taxotere® (or docetaxel).

The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.