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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01324583
• Other study ID #: TED11576
• Secondary ID: U1111-1115-4154
• Status: Completed
• Phase: Phase 1
• First received: March 22, 2011
• Last updated: January 6, 2015
• Start date: January 2011
• Est. completion date: November 2014

Study information

• Verified date: January 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

• To assess the tolerability at global doses

Secondary Objectives:

• Safety

• Pharmacokinetics

• Efficacy

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 73 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Cabazitaxel (XRP6258)
Pharmaceutical form:solution Route of administration: intravenous
• prednisolone
Pharmaceutical form:tablet Route of administration: oral

Locations

Country	Name	City	State
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 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

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of maximum tolerated dose		up to 18 months	No
Secondary	number of participants with treatment emergent adverse events		up to 18 months	Yes
Secondary	Pharmakokinetic parameters of Cabazitaxel		up to 18 months	No
Secondary	Prostate Specific Antigen (PSA) Response		up to 18 months	No