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

NCT01324583 | Completed Phase 1

• 2 other identifiers: TED11576U1111-1115-4154
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 21

Brief Summary

Primary Objective:

• To assess the tolerability at global doses Secondary Objectives:
• Safety
• Pharmacokinetics
• Efficacy

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Identification of maximum tolerated dose

  up to 18 months

Secondary Outcomes (3)

• number of participants with treatment emergent adverse events

  up to 18 months

• Pharmakokinetic parameters of Cabazitaxel

  up to 18 months

• Prostate Specific Antigen (PSA) Response

  up to 18 months

Study Arms (1)

Arm 1

EXPERIMENTAL

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); Drug: prednisolone

Interventions

Cabazitaxel (XRP6258) DRUG

Pharmaceutical form:solution Route of administration: intravenous

Arm 1

prednisolone DRUG

Pharmaceutical form:tablet Route of administration: oral

Arm 1

Eligibility Criteria

• Age: 20 Years - 73 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (21)

Investigational Site Number 392011

Bunkyō City, Japan

Location

Investigational Site Number 392021

Fukuoka, Japan

Location

Investigational Site Number 392014

Hamamatsu, Japan

Location

Investigational Site Number 392009

Itabashi-Ku, Japan

Location

Investigational Site Number 392001

Kashiwa-Shi, Japan

Location

Investigational Site Number 392020

Kita-Gun, Japan

Location

Investigational Site Number 392002

Kōtoku, Japan

Location

Investigational Site Number 392016

Kyoto, Japan

Location

Investigational Site Number 392017

Kyoto, Japan

Location

Investigational Site Number 392008

Maebashi, Japan

Location

Investigational Site Number 392012

Minatoku, Japan

Location

Investigational Site Number 392015

Nagoya, Japan

Location

Investigational Site Number 392019

Osaka Sayama-Shi, Japan

Location

Investigational Site Number 392004

Sapporo, Japan

Location

Investigational Site Number 392005

Sendai, Japan

Location

Investigational Site Number 392010

Shinjuku-Ku, Japan

Location

Investigational Site Number 392018

Suita-Shi, Japan

Location

Investigational Site Number 392003

Sunto-Gun, Japan

Location

Investigational Site Number 392007

Tsukuba, Japan

Location

Investigational Site Number 392006

Yamagata, Japan

Location

Investigational Site Number 392013

Yokohama, Japan

Location

Related Publications (1)

• Nozawa M, Mukai H, Takahashi S, Uemura H, Kosaka T, Onozawa Y, Miyazaki J, Suzuki K, Okihara K, Arai Y, Kamba T, Kato M, Nakai Y, Furuse H, Kume H, Ide H, Kitamura H, Yokomizo A, Kimura T, Tomita Y, Ohno K, Kakehi Y. Japanese phase I study of cabazitaxel in metastatic castration-resistant prostate cancer. Int J Clin Oncol. 2015 Oct;20(5):1026-34. doi: 10.1007/s10147-015-0820-9. Epub 2015 Mar 26.

  PMID: 25809824 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

cabazitaxel; XRP6258; Prednisolone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2011
• First Posted: March 29, 2011
• Study Start: January 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: January 7, 2015

Record last verified: 2015-01

Locations

JP (21)