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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01254279
• Date of registration: 02/12/2010
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: Early Access to Cabazitaxel in Patients With Metastatic Hormone Refractory Prostate Cancer Previously Treated With a Docetaxel-containing Regimen
• Scientific 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
• Date of first enrolment: December 2010
• Target sample size: 984
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01254279
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Prostate Cancer Metastatic

Intervention(s)

Drug: CABAZITAXEL

Primary Outcome(s)

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(s)

To document safety of cabazitaxel in these patients [Time Frame: Up to 35 weeks]

Secondary ID(s)

U1111-1115-2476

2010-021128-92

CABAZ_C_05331

Source(s) of Monetary Support

Please refer to primary and secondary sponsors