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Randomized, Open Label, Multi-Center Study Comparing Cabazitaxel at 25 mg/m2 and at 20 mg/m² in Combination With Prednisone Every 3 Weeks to Docetaxel in Combination With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer Not Pretreated With Chemotherapy


Phase 3
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

Randomized, Open Label, Multi-Center Study Comparing Cabazitaxel at 25 mg/m2 and at 20 mg/m² in Combination With Prednisone Every 3 Weeks to Docetaxel in Combination With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer Not Pretreated With Chemotherapy


Patients will be treated until progressive disease, unacceptable toxicity, or patient's
refusal of further study treatment. All patients will be followed when on study treatment
and after completion of study treatment during follow up period until death or the study
cutoff date, whichever comes first.

Inclusion Criteria


Inclusion criteria :

- I 01. Histologically- or cytologically-confirmed prostate adenocarcinoma.

- I 02. Metastatic disease.

- I 03. Progressive disease while receiving hormonal therapy or after surgical
castration .

Exclusion criteria:

- E 01. Prior chemotherapy for prostate cancer,

- E 02. Less than 28 days elapsed from prior treatment with estramustine, radiotherapy
or surgery to the time of randomization. Patients may be on biphosphonates prior to
study entry.

- E 03. Prior isotope therapy, whole pelvic radiotherapy, or radiotherapy to >30% of
bone marrow.

- E 04. Adverse events (excluding alopecia and those listed in the specific exclusion
criteria) from any prior anticancer therapy of grade >1(National Cancer Institute
Common Terminology Criteria [NCI CTCAE] v4.03) at the time of randomization.

- E 05. Less than 18 years (or country's legal age of majority if the legal age is >18
years).

- E 06. Eastern Cooperative Oncology Group (ECOG) performance status >2.

- E 07. History of brain metastases, uncontrolled spinal cord compression, or
carcinomatous meningitis or new evidence of brain or leptomeningeal disease.

- E 08. Prior malignancy.

- E 09. Participation in another clinical trial and any concurrent treatment with any
investigational drug within 30 days prior to randomization.

- E 10. Any of the following within 6 months prior to study enrollment: myocardial
infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft,
NYHA class III or IV congestive heart failure, stroke or transient ischemic attack.

- E 11. Any of the following within 3 months prior to randomization: treatment
resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or
inflammatory bowel disease, diverticulitis, pulmonary embolism, or other uncontrolled
thromboembolic event.

- E 12. Acquired immunodeficiency syndrome (AIDS-related illnesses) or known HIV
disease requiring antiretroviral treatment.

- E 13. Any severe acute or chronic medical condition which could impair the ability of
the patient to participate to the study or interfere with interpretation of study
results, or patient unable to comply with the study procedures.

- E 14. Absence of signed and dated Institutional Review Board (IRB)-approved patient
informed consent form prior to enrollment into the study.

- E 15. Patients with reproductive potential who do not agree to use accepted and
effective method of contraception during the study treatment period.

- E 16. History of hypersensitivity to docetaxel, or polysorbate 80.

- E 17. Inadequate organ and bone marrow function

- E 18. Contraindications to the use of corticosteroid treatment.

- E 19. Symptomatic peripheral neuropathy grade >2 (National Cancer Institute Common
Terminology Criteria [NCI CTCAE] v.4.03).

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Time Frame:

up to 57 months

Safety Issue:

No

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

EFC11784

NCT ID:

NCT01308567

Start Date:

May 2011

Completion Date:

December 2017

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Investigational Site Number 840021Minneapolis, Minnesota  55426
Investigational Site Number 840003San Diego, California  92123
Investigational Site Number 840014San Francisco, California  94143
Investigational Site Number 840030Tustin, California  92780
Investigational Site Number 840009Modesto, California  95355
Investigational Site Number 840005Lansing, Michigan  48912
Investigational Site Number 840004Muscle Shoals, Alabama  35661
Investigational Site Number 840012San Francisco, California  94143
Investigational Site Number 840019Denver, Colorado  80262
Investigational Site Number 840013Boca Raton, Florida  33486
Investigational Site Number 840035Jacksonville, Florida  32256
Investigational Site Number 840001Port St. Lucie, Florida  34952
Investigational Site Number 840015Decatur, Illinois  62526
Investigational Site Number 840018Wichita, Kansas  67214
Investigational Site Number 840010Paducah, Kentucky  42002
Investigational Site Number 840008New Orleans, Louisiana  70112
Investigational Site Number 840006Rockville, Maryland  20850
Investigational Site Number 840238Boston, Massachusetts  02114
Investigational Site Number 840138Boston, Massachusetts  02115
Investigational Site Number 840038Brookline, Massachusetts  02115
Investigational Site Number 840016Kansas City, Missouri  64128
Investigational Site Number 840020Lincoln, Nebraska  68506
Investigational Site Number 840017East Orange, New Jersey  07018
Investigational Site Number 840033Albuquerque, New Mexico  87109
Investigational Site Number 840036Raleigh, North Carolina  27607
Investigational Site Number 840011Washington, North Carolina  27889
Investigational Site Number 840026Akron, Ohio  44302
Investigational Site Number 840023Cleveland, Ohio  44106
Investigational Site Number 840032Dunmore, Pennsylvania  18512
Investigational Site Number 840007Pawtucket, Rhode Island  02860
Investigational Site Number 840037Myrtle Beach, South Carolina  29572
Investigational Site Number 840028Chattanooga, Tennessee  37404