Clinical trial NCT01324583: Dose Escalation Study With Cabazitaxel in Combination With Daily Prednisolone in Patients With Hormone Refractory Prostate Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2011-03-29
Enrollment: 48
Sex: MALE
Minimum age (years): 20
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary Objective:

* To assess the tolerability at global doses

Secondary Objectives:

* Safety
* Pharmacokinetics
* Efficacy

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

Eligibility 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.

Primary outcomes:
measure: Identification of maximum tolerated dose
timeFrame: up to 18 months
Secondary outcomes:
measure: number of participants with treatment emergent adverse events
timeFrame: up to 18 months
measure: Pharmakokinetic parameters of Cabazitaxel
timeFrame: up to 18 months
measure: Prostate Specific Antigen (PSA) Response
timeFrame: up to 18 months
Other outcomes:
Locations:
city: Bunkyo-Ku
country: Japan
facility: Investigational Site Number 392011
city: Fukuoka-Shi
country: Japan
facility: Investigational Site Number 392021
city: Hamamatsu-Shi
country: Japan
facility: Investigational Site Number 392014
city: Itabashi-Ku
country: Japan
facility: Investigational Site Number 392009
city: Kashiwa-Shi
country: Japan
facility: Investigational Site Number 392001
city: Kita-Gun
country: Japan
facility: Investigational Site Number 392020
city: Koto-Ku
country: Japan
facility: Investigational Site Number 392002
city: Kyoto-Shi
country: Japan
facility: Investigational Site Number 392016
city: Kyoto-Shi
country: Japan
facility: Investigational Site Number 392017
city: Maebashi-Shi
country: Japan
facility: Investigational Site Number 392008
city: Minato-Ku
country: Japan
facility: Investigational Site Number 392012
city: Nagoya-Shi
country: Japan
facility: Investigational Site Number 392015
city: Osaka Sayama-Shi
country: Japan
facility: Investigational Site Number 392019
city: Sapporo-Shi
country: Japan
facility: Investigational Site Number 392004
city: Sendai-Shi
country: Japan
facility: Investigational Site Number 392005
city: Shinjuku-Ku
country: Japan
facility: Investigational Site Number 392010
city: Suita-Shi
country: Japan
facility: Investigational Site Number 392018
city: Sunto-Gun
country: Japan
facility: Investigational Site Number 392003
city: Tsukuba-Shi
country: Japan
facility: Investigational Site Number 392007
city: Yamagata-Shi
country: Japan
facility: Investigational Site Number 392006
city: Yokohama-Shi
country: Japan
facility: Investigational Site Number 392013
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: 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.