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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01324583
Recruitment Status : Completed
First Posted : March 29, 2011
Last Update Posted : January 7, 2015
Information provided by (Responsible Party):

Brief Summary:

Primary Objective:

  • To assess the tolerability at global doses

Secondary Objectives:

  • Safety
  • Pharmacokinetics
  • Efficacy

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Cabazitaxel (XRP6258) Drug: prednisolone Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
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
Study Start Date : January 2011
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 73 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01324583

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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
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Study Director: Clinical Sciences & Operations Sanofi

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sanofi Identifier: NCT01324583     History of Changes
Other Study ID Numbers: TED11576
U1111-1115-4154 ( Other Identifier: UTN )
First Posted: March 29, 2011    Key Record Dates
Last Update Posted: January 7, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Methylprednisolone Acetate
Prednisolone 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