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

Prostate Cancer Metastatic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02074137
• Other study ID #: CABAZL06499
• Secondary ID: U1111-1131-3161
• Status: Completed
• Phase: Phase 4
• First received: February 26, 2014
• Last updated: June 1, 2016
• Start date: July 2014
• Est. completion date: March 2016

Study information

• Verified date: June 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer Metastatic
• Prostatic Neoplasms

Intervention

Drug:
• CABAZITAXEL XRP6258
Pharmaceutical form:Solution Route of administration: Intravenous
• Prednisone
Pharmaceutical form:Tablet Route of administration: Oral
• Prednisolone
Pharmaceutical form:Tablet Route of administration: Oral

Locations

Country	Name	City	State
India	Investigational Site Number 356005	Kollkata
India	Investigational Site Number 356003	New Delhi
India	Investigational Site Number 356002	Trivandrum

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with Related Serious Adverse Events		up to13 months	Yes
Secondary	Evaluation of use of cabazitaxel in terms of treatment duration, number of cycles, dose modifications		up to 13 months	No
Secondary	Radiological overall response (if radiological tumor assessment done) using Recist criteria		up to 13 months	No
Secondary	Number of patients with at least 50% decrease in PSA		up to 13 months	No