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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

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, Learn About Clinical Studies.

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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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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    
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 Acetate
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
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