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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: October 28, 2014
Last verified: October 2014

March 22, 2011
October 28, 2014
January 2011
December 2014   (final data collection date for primary outcome measure)
Identification of maximum tolerated dose [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01324583 on ClinicalTrials.gov Archive Site
  • 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 ]
  • number of participants with treatment emergent adverse events [ Time Frame: up to 18 months ] [ Designated as safety issue: Yes ]
  • Maximum plasma concentration (Cmax) 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 ]
Not Provided
Not Provided
 
Dose Escalation Study With Cabazitaxel in Combination With Daily Prednisolone in Patients With Hormone Refractory Prostate Cancer
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

Primary Objective:

  • To assess the tolerability at global doses

Secondary Objectives:

  • Safety
  • Pharmacokinetics
  • Efficacy

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

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • Drug: Cabazitaxel (XRP6258)

    Pharmaceutical form:solution

    Route of administration: intravenous

  • Drug: prednisolone

    Pharmaceutical form:tablet

    Route of administration: oral

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

Interventions:
  • Drug: Cabazitaxel (XRP6258)
  • Drug: prednisolone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
46
December 2014
December 2014   (final data collection date for primary outcome measure)

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.

Male
20 Years to 73 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01324583
TED11576, U1111-1115-4154
No
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP