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

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ClinicalTrials.gov Identifier: NCT01254279
Recruitment Status : Completed
First Posted : December 6, 2010
Last Update Posted : January 21, 2015
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE December 2, 2010
First Posted Date  ICMJE December 6, 2010
Last Update Posted Date January 21, 2015
Study Start Date  ICMJE December 2010
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2010)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01254279 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2010)
To document safety of cabazitaxel in these patients [ Time Frame: Up to 35 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Access to Cabazitaxel in Patients With Metastatic Hormone Refractory Prostate Cancer Previously Treated With a Docetaxel-containing Regimen
Official Title  ICMJE 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
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer Metastatic
Intervention  ICMJE Drug: CABAZITAXEL
Pharmaceutical form: Concentrate For Solution For Infusion Route of administration: Intravenous
Study Arms  ICMJE Experimental: Cabazitaxel
Cabazitaxel 25 mg/m² intravenously every 3 weeks, in combination with oral prednisone or prednisolone 10 mg daily
Intervention: Drug: CABAZITAXEL
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 19, 2015)
984
Original Estimated Enrollment  ICMJE
 (submitted: December 2, 2010)
1000
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Bosnia and Herzegovina,   Bulgaria,   Canada,   Croatia,   Czech Republic,   Denmark,   Finland,   Hungary,   India,   Ireland,   Italy,   Kazakhstan,   Luxembourg,   Malaysia,   Mexico,   Philippines,   Poland,   Portugal,   Romania,   Serbia,   Singapore,   Slovakia,   Spain,   Sweden,   Taiwan,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01254279
Other Study ID Numbers  ICMJE CABAZ_C_05331
2010-021128-92 ( EudraCT Number )
U1111-1115-2476 ( Other Identifier: UTN )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP