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
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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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 984 participants |
Allocation: | N/A |
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 |

Arm | Intervention/treatment |
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Experimental: Cabazitaxel
Cabazitaxel 25 mg/m² intravenously every 3 weeks, in combination with oral prednisone or prednisolone 10 mg daily
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Drug: CABAZITAXEL
Pharmaceutical form: Concentrate For Solution For Infusion Route of administration: Intravenous |
- 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 ]
- To document safety of cabazitaxel in these patients [ Time Frame: Up to 35 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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.

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

Study Director: | Clinical Sciences & Operations | Sanofi |
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT01254279 |
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 |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |