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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01324583
First received: March 22, 2011
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • number of participants with treatment emergent adverse events [ Time Frame: up to 18 months ] [ Designated as safety issue: Yes ]
  • Pharmakokinetic parameters of Cabazitaxel [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]
  • Prostate Specific Antigen (PSA) Response [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 46
Study Start Date: January 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 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.

  Eligibility

Ages Eligible for Study:   20 Years to 73 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01324583

Locations
Japan
Investigational Site Number 392005
Aoba-Ku Sendai-Shi, Japan
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 392017
Kyoto-Shi, Japan
Investigational Site Number 392016
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 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
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01324583     History of Changes
Other Study ID Numbers: TED11576, U1111-1115-4154
Study First Received: March 22, 2011
Last Updated: April 14, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on April 21, 2014