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

NCT ID: NCT02074137

Last Updated: 2016-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-03-31

Brief Summary

Primary Objective:

To evaluate the safety of cabazitaxel (Jevtana) in patients with metastatic hormone refractory prostate cancer

Secondary Objectives:

1. To describe the use of cabazitaxel (Jevtana) in combination with oral prednisolone for the treatment of patients with metastatic Hormone Refractory Prostate Cancer

2. To describe patient profile in terms of demography, disease characteristics and prior treatment history

3. 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.

Conditions

Prostate Cancer Metastatic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cabazitaxel

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

Group Type: EXPERIMENTAL

CABAZITAXEL XRP6258

Intervention Type: DRUG

Pharmaceutical form:Solution Route of administration: Intravenous

Prednisone

Intervention Type: DRUG

Pharmaceutical form:Tablet Route of administration: Oral

Prednisolone

Intervention Type: DRUG

Pharmaceutical form:Tablet Route of administration: Oral

Interventions

CABAZITAXEL XRP6258

Pharmaceutical form:Solution Route of administration: Intravenous

Intervention Type: DRUG

Prednisone

Pharmaceutical form:Tablet Route of administration: Oral

Intervention Type: DRUG

Prednisolone

Pharmaceutical form:Tablet Route of administration: Oral

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 356005

Kollkata, , India

Investigational Site Number 356003

New Delhi, , India

Investigational Site Number 356002

Trivandrum, , India

Countries

India

Other Identifiers

U1111-1131-3161

Identifier Type: OTHER

Identifier Source: secondary_id

CABAZL06499

Identifier Type: -

Identifier Source: org_study_id