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

This study has been completed.
Information provided by (Responsible Party):
Sanofi Identifier:
First received: March 22, 2011
Last updated: January 6, 2015
Last verified: January 2015

Primary Objective:

  • To assess the tolerability at global doses

Secondary Objectives:

  • Safety
  • Pharmacokinetics
  • Efficacy

Condition Intervention Phase
Prostate Cancer Drug: Cabazitaxel (XRP6258) Drug: prednisolone Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Dose Escalation, Safety and Pharmacokinetics Phase I Study With Cabazitaxel Administered as a 1-hour Intravenous Infusion Every 3 Weeks in Combination With Daily Prednisolone in Patients With Hormone Refractory Prostate Cancer

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Identification of maximum tolerated dose [ Time Frame: up to 18 months ]

Secondary Outcome Measures:
  • number of participants with treatment emergent adverse events [ Time Frame: up to 18 months ]
  • Pharmakokinetic parameters of Cabazitaxel [ Time Frame: up to 18 months ]
  • Prostate Specific Antigen (PSA) Response [ Time Frame: up to 18 months ]

Enrollment: 48
Study Start Date: January 2011
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1

Patients will receive cabazitaxel as the dose of corresponded level

1-hour intravenous infusion every 3 weeks plus prednisolone 10 mg orally given daily: Dose Level Cabazitaxel Dose Level -1: 15 mg/m², Level 1: 20 mg/m², Level 2: 25 mg/m²

Drug: Cabazitaxel (XRP6258)

Pharmaceutical form:solution

Route of administration: intravenous

Drug: prednisolone

Pharmaceutical form:tablet

Route of administration: oral

Detailed Description:
The duration of screening within 28 days, treatment 3 weeks/cycle and follow-up 30 days after the last cabazitaxel administration.

Ages Eligible for Study:   20 Years to 73 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01324583

Investigational Site Number 392011
Bunkyo-Ku, Japan
Investigational Site Number 392021
Fukuoka-Shi, Japan
Investigational Site Number 392014
Hamamatsu-Shi, Japan
Investigational Site Number 392009
Itabashi-Ku, Japan
Investigational Site Number 392001
Kashiwa-Shi, Japan
Investigational Site Number 392020
Kita-Gun, Japan
Investigational Site Number 392002
Koto-Ku, Japan
Investigational Site Number 392016
Kyoto-Shi, Japan
Investigational Site Number 392017
Kyoto-Shi, Japan
Investigational Site Number 392008
Maebashi-Shi, Japan
Investigational Site Number 392012
Minato-Ku, Japan
Investigational Site Number 392015
Nagoya-Shi, Japan
Investigational Site Number 392019
Osaka Sayama-Shi, Japan
Investigational Site Number 392004
Sapporo-Shi, Japan
Investigational Site Number 392005
Sendai-Shi, Japan
Investigational Site Number 392010
Shinjuku-Ku, Japan
Investigational Site Number 392018
Suita-Shi, Japan
Investigational Site Number 392003
Sunto-Gun, Japan
Investigational Site Number 392007
Tsukuba-Shi, Japan
Investigational Site Number 392006
Yamagata-Shi, Japan
Investigational Site Number 392013
Yokohama-Shi, Japan
Sponsors and Collaborators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sanofi Identifier: NCT01324583     History of Changes
Other Study ID Numbers: TED11576
U1111-1115-4154 ( Other Identifier: UTN )
Study First Received: March 22, 2011
Last Updated: January 6, 2015

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Prednisolone acetate
Methylprednisolone acetate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents processed this record on September 25, 2017