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

NCT02074137 | Completed Phase 4

• 2 other identifiers: CABAZL06499U1111-1131-3161
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

Brief Summary

Primary Objective: To evaluate the safety of cabazitaxel (Jevtana) in patients with metastatic hormone refractory prostate cancer Secondary Objectives:

1. 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. 2.To describe patient profile in terms of demography, disease characteristics and prior treatment history
3. 3.To describe efficacy outcomes: radiological response (if available) using Recist criteria V 1.1 and Prostate Specific Antigen (PSA) response

Conditions

Prostate Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• Number of patients with Related Serious Adverse Events

  up to13 months

Secondary Outcomes (3)

• 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

Study Arms (1)

Cabazitaxel

EXPERIMENTAL

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

Drug: CABAZITAXEL XRP6258; Drug: Prednisone; Drug: Prednisolone

Interventions

CABAZITAXEL XRP6258 DRUG

Pharmaceutical form:Solution Route of administration: Intravenous

Cabazitaxel

Prednisone DRUG

Pharmaceutical form:Tablet Route of administration: Oral

Cabazitaxel

Prednisolone DRUG

Pharmaceutical form:Tablet Route of administration: Oral

Cabazitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (3)

Investigational Site Number 356005

Kollkata, 700053, India

Location

Investigational Site Number 356003

New Delhi, 110085, India

Location

Investigational Site Number 356002

Trivandrum, 695011, India

Location

MeSH Terms

Interventions

Prednisone; Prednisolone

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienetriols

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: February 28, 2014
• Study Start: July 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: June 2, 2016

Record last verified: 2016-06

Locations

IN (3)