Early Access to Cabazitaxel in Patients With Metastatic Hormone Refractory Prostate Cancer Previously Treated With a Docetaxel-containing Regimen

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01254279
First received: December 2, 2010
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to allow patients similar to that evaluated in the TROPIC trial (NCT00417079), and Investigators access to cabazitaxel for the management of metastatic Hormone Refractory Prostate Cancer (mHRPC) in those patients who have progressed during or after docetaxel and to document the overall safety of cabazitaxel in these patients.

Please note that in each country, patient recruitment will end when cabazitaxel becomes commercially available.


Condition Intervention Phase
Prostate Cancer Metastatic
Drug: CABAZITAXEL
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicentre, Single-arm, Open Label Clinical Trial Intended to Provide Early Access to Cabazitaxel in Patients With Metastatic Hormone Refractory Prostate Cancer Previously Treated With a Docetaxel-containing Regimen and to Document Safety of Cabazitaxel in These Patients

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • To provide early access to cabazitaxel in patients with metastatic hormone refractory prostate cancer previously treated with a docetaxel-containing regimen [ Time Frame: Up to 30 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To document safety of cabazitaxel in these patients [ Time Frame: Up to 35 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: December 2010
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cabazitaxel
Cabazitaxel 25 mg/m² intravenously every 3 weeks, in combination with oral prednisone or prednisolone 10 mg daily
Drug: CABAZITAXEL
Pharmaceutical form: Concentrate For Solution For Infusion Route of administration: Intravenous

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0-2
  • Life-expectancy ≥3 months
  • Adequate bone marrow, liver, and renal function: Neutrophils> 1500 /mm3; Hemoglobin > 10 g/dL; Platelets > 100 x109/L; Bilirubin < ULN; SGOT (AST) < 1.5xULN; SGPT (ALT) < 1.5xULN; Creatinine < 1.5xULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance < 60 mL/min should be excluded.

Exclusion criteria:

  • Prior radiotherapy to ≥ 40% of bone marrow
  • Prior radionuclide therapy (samarium-153, strontium-89, P-32…)
  • 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 (except superficial basal cell skin cancer)
  • 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 cardiac arrhythmias, angina pectoris, hypertension or diabetes mellitus). History of congestive heart failure (NYHA III or IV) or myocardial infarction within last 6 months is also not allowed.
  • Concurrent or planned treatment with potent inhibitors or inducers of cytochrome P450 3A4/5
  • Participation in a 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01254279

  Show 158 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01254279     History of Changes
Other Study ID Numbers: CABAZ_C_05331, 2010-021128-92, U1111-1115-2476
Study First Received: December 2, 2010
Last Updated: February 20, 2014
Health Authority: Czech Republic: State Institute for Drug Control

Additional relevant MeSH terms:
Prostatic Neoplasms
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014