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Evaluation of Safety of Cabazitaxel (Jevtana) in Patients With Metastatic Hormone Refractory Prostate Cancer

Primary Purpose

Prostate Cancer Metastatic

Status

Completed

Phase

Phase 4

Locations

India

Study Type

Interventional

Intervention

CABAZITAXEL XRP6258

Prednisone

Prednisolone

About this trial

This is an interventional treatment trial for Prostate Cancer Metastatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion criteria :

Metastatic hormone refractory prostate cancer (mHRPC) previously treated with a docetaxel-containing regimen
Disease Progression during or after docetaxel-containing regimen for mHRPC
Surgical or medical castration
Patient is ≥ 18 years and ≤ 75 years of age
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
Adequate bone marrow, liver, and renal function: Neutrophils> 1500 /mm3; Hemoglobin > 10 g/dL; Platelets > 100 x109/L; Bilirubin < Upper Normal Limit (ULN); Serum Glutamate Oxaloacetate Transaminase (Aspartate Aminotransferase)/SGOT (AST) < 1.5xULN; Serum Glutamate Pyruvate Transaminase (Alanine Aminotransferase)/SGPT (ALT) < 1.5xULN; Creatinine < 1.5xULN. In case of creatinine > 1.0 x ULN and < or = 1.5 x ULN, calculated creatinine clearance according to CKD-EPI formula should be > or = 60 ml/min.
Written informed consent must be obtained prior to any study related procedures

Exclusion criteria:

Prior radiotherapy to ≥ 40% of bone marrow
Previous treatment with cabazitaxel (Jevtana®)
Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrollment
Active grade ≥2 peripheral neuropathy
Active grade ≥2 stomatitis
Active infection requiring systemic antibiotic or anti-fungal medication
Active cancer (other than mHRPC) including prior malignancy from which the patient has been disease-free for ≤5 years
Known brain or leptomeningeal involvement
History of severe hypersensitivity reaction (≥grade 3) to docetaxel
History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs
History of severe hypersensitivity reaction (≥grade 3) or intolerance to prednisone or prednisolone
Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus)
Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a 2 weeks wash-out period is necessary for patients who are already on these treatments). Participation in any other clinical trial with any investigational drug
Patient with reproductive potential not implementing accepted and effective method of contraception

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sites / Locations

Investigational Site Number 356005
Investigational Site Number 356003
Investigational Site Number 356002

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cabazitaxel

Arm Description

Cabazitaxel 25 mg/m² intravenously every 3 weeks, in combination with oral prednisone or prednisolone 10 mg daily

Outcomes

Primary Outcome Measures

Number of patients with Related Serious Adverse Events

Secondary Outcome Measures

Evaluation of use of cabazitaxel in terms of treatment duration, number of cycles, dose modifications

Radiological overall response (if radiological tumor assessment done) using Recist criteria

Number of patients with at least 50% decrease in PSA

Full Information

NCT ID

NCT02074137

First Posted

February 26, 2014

Last Updated

June 1, 2016

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT02074137

Brief Title

Evaluation of Safety of Cabazitaxel (Jevtana) in Patients With Metastatic Hormone Refractory Prostate Cancer

Official Title

Multicentre, Single Arm, Open Label, Non Controlled Phase IV Clinical Trial to Evaluate Safety of Cabazitaxel (Jevtana) in Combination With Oral Prednisone (or Prednisolone) for the Treatment of Patients With Metastatic Hormone Refractory Prostate Cancer Previously Treated With a Docetaxel-containing Regimen

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Completed

Study Start Date

July 2014 (undefined)

Primary Completion Date

March 2016 (Actual)

Study Completion Date

March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Primary Objective: To evaluate the safety of cabazitaxel (Jevtana) in patients with metastatic hormone refractory prostate cancer Secondary Objectives: To describe the use of cabazitaxel (Jevtana) in combination with oral prednisolone for the treatment of patients with metastatic Hormone Refractory Prostate Cancer To describe patient profile in terms of demography, disease characteristics and prior treatment history To describe efficacy outcomes: radiological response (if available) using Recist criteria V 1.1 and Prostate Specific Antigen (PSA) response

Detailed Description

The study consists of: a screening phase (maximum length of 7-day). a treatment phase with 21-day study treatment cycles. Patients continue to receive treatment until disease progression , death, unacceptable toxicity, investigator's decision or withdrawal of consent. a 30-day follow-up visit after the last dose of study medication.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer Metastatic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cabazitaxel

Arm Type

Experimental

Arm Description

Cabazitaxel 25 mg/m² intravenously every 3 weeks, in combination with oral prednisone or prednisolone 10 mg daily

Intervention Type

Drug

Intervention Name(s)

CABAZITAXEL XRP6258

Intervention Description

Pharmaceutical form:Solution Route of administration: Intravenous

Intervention Type

Drug

Intervention Name(s)

Prednisone

Intervention Description

Pharmaceutical form:Tablet Route of administration: Oral

Intervention Type

Drug

Intervention Name(s)

Prednisolone

Intervention Description

Pharmaceutical form:Tablet Route of administration: Oral

Primary Outcome Measure Information:

Title

Number of patients with Related Serious Adverse Events

Time Frame

up to13 months

Secondary Outcome Measure Information:

Title

Evaluation of use of cabazitaxel in terms of treatment duration, number of cycles, dose modifications

Time Frame

up to 13 months

Title

Radiological overall response (if radiological tumor assessment done) using Recist criteria

Time Frame

up to 13 months

Title

Number of patients with at least 50% decrease in PSA

Time Frame

up to 13 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria : Metastatic hormone refractory prostate cancer (mHRPC) previously treated with a docetaxel-containing regimen Disease Progression during or after docetaxel-containing regimen for mHRPC Surgical or medical castration Patient is ≥ 18 years and ≤ 75 years of age Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 Adequate bone marrow, liver, and renal function: Neutrophils> 1500 /mm3; Hemoglobin > 10 g/dL; Platelets > 100 x109/L; Bilirubin < Upper Normal Limit (ULN); Serum Glutamate Oxaloacetate Transaminase (Aspartate Aminotransferase)/SGOT (AST) < 1.5xULN; Serum Glutamate Pyruvate Transaminase (Alanine Aminotransferase)/SGPT (ALT) < 1.5xULN; Creatinine < 1.5xULN. In case of creatinine > 1.0 x ULN and < or = 1.5 x ULN, calculated creatinine clearance according to CKD-EPI formula should be > or = 60 ml/min. Written informed consent must be obtained prior to any study related procedures Exclusion criteria: Prior radiotherapy to ≥ 40% of bone marrow Previous treatment with cabazitaxel (Jevtana®) Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrollment Active grade ≥2 peripheral neuropathy Active grade ≥2 stomatitis Active infection requiring systemic antibiotic or anti-fungal medication Active cancer (other than mHRPC) including prior malignancy from which the patient has been disease-free for ≤5 years Known brain or leptomeningeal involvement History of severe hypersensitivity reaction (≥grade 3) to docetaxel History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs History of severe hypersensitivity reaction (≥grade 3) or intolerance to prednisone or prednisolone Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus) Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a 2 weeks wash-out period is necessary for patients who are already on these treatments). Participation in any other clinical trial with any investigational drug Patient with reproductive potential not implementing accepted and effective method of contraception The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Investigational Site Number 356005

City

Kollkata

ZIP/Postal Code

700053

Country

India

Facility Name

Investigational Site Number 356003

City

New Delhi

ZIP/Postal Code

110085

Country

India

Facility Name

Investigational Site Number 356002

City

Trivandrum

ZIP/Postal Code

695011

Country

India

12. IPD Sharing Statement

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Evaluation of Safety of Cabazitaxel (Jevtana) in Patients With Metastatic Hormone Refractory Prostate Cancer

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