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

Sanofi

Status and phase

Completed

Phase 4

Conditions

Prostate Cancer Metastatic

Treatments

Drug: Prednisolone

Drug: CABAZITAXEL XRP6258

Drug: Prednisone

Study type

Interventional

Funder types

Industry

Identifiers

U1111-1131-3161 (Other Identifier)

CABAZL06499

Details and patient eligibility

About

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

Full 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.

Enrollment

10 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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