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

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

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

Study Overview

• Status: Completed
• Conditions: Prostate Cancer Metastatic
• Intervention / Treatment: Drug: Prednisone; Drug: CABAZITAXEL XRP6258; Drug: Prednisolone

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Kollkata, India, 700053
    • Investigational Site Number 356005
  • New Delhi, India, 110085
    • Investigational Site Number 356003
  • Trivandrum, India, 695011
    • Investigational Site Number 356002

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cabazitaxel; Cabazitaxel 25 mg/m² intravenously every 3 weeks, in combination with oral prednisone or prednisolone 10 mg daily	Drug: Prednisone; Pharmaceutical form:Tablet Route of administration: Oral; Drug: CABAZITAXEL XRP6258; Pharmaceutical form:Solution Route of administration: Intravenous; Drug: Prednisolone; Pharmaceutical form:Tablet Route of administration: Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients with Related Serious Adverse Events	up to13 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluation of use of cabazitaxel in terms of treatment duration, number of cycles, dose modifications	up to 13 months
Radiological overall response (if radiological tumor assessment done) using Recist criteria	up to 13 months
Number of patients with at least 50% decrease in PSA	up to 13 months

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (ACTUAL): March 1, 2016
• Study Completion (ACTUAL): March 1, 2016

Study Registration Dates

• First Submitted: February 26, 2014
• First Submitted That Met QC Criteria: February 26, 2014
• First Posted (ESTIMATE): February 28, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): June 2, 2016
• Last Update Submitted That Met QC Criteria: June 1, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisolone; Prednisone
• Other Study ID Numbers: CABAZL06499; U1111-1131-3161 (OTHER: UTN)