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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Metastatic Drug: CABAZITAXEL Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 984 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2010
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To document safety of cabazitaxel in these patients [ Time Frame: Up to 35 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01254279


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Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01254279     History of Changes
Other Study ID Numbers: CABAZ_C_05331
2010-021128-92 ( EudraCT Number )
U1111-1115-2476 ( Other Identifier: UTN )
First Posted: December 6, 2010    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
 Hormones
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs