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Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen

Phase 3
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen

Patients will be treated until progressive disease, unacceptable toxicity, patient's refusal
of further study treatment or for a maximum of 10 cycles. 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. Diagnosis of histologically or cytologically proven prostate adenocarcinoma, that is
resistant to hormone therapy and previously treated with a docetaxel-containing regimen.

I 02. Patient must have either measurable or non-measurable disease. I 03. Received prior
castration by orchiectomy and/or Luteinizing Hormone-Releasing Hormone (LH-RH) agonist
with or without antiandrogen, antiandrogen withdrawal, monotherapy with estramustine, or
other hormonal agents.

I 04. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 - 2 (ie, patient
must be ambulatory, capable of all self-care, and up and about more than 50% of waking

I 05. Age ≥18 years (or country's legal age of majority if the legal age is > 18 years).

Exclusion criteria:

E 01. Previous treatment with mitoxantrone or cabazitaxel. E 02. Prior isotope therapy or
radiotherapy to ≥30% of bone marrow. In case of prior isotope therapy 12 weeks must have
elapsed prior to first study drug administration.

E 03. 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 04. Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks
prior to enrollment in the study.

E 05. Prior malignancy. Adequately treated basal cell or squamous cell skin or superficial
(pTis, pTa, and pT1) bladder cancer are allowed, as well as any other cancer for which
chemotherapy has been completed ≥ 5 years ago and from which the patient has been
disease-free for ≥ 5 years.

E 06. Participation in another clinical trial and any concurrent treatment with any
investigational drug within 30 days prior to randomization.

E 07. Known brain or leptomeningeal involvement. E 08. Other concurrent serious illness or
medical conditions E 09. Uncontrolled cardiac arrhythmias, angina pectoris, and/or
hypertension. History of congestive heart failure (NYHA III or IV) or myocardial
infarction within last 6 months is also not allowed.

E 10. Any severe acute or chronic medical condition which could impair the ability of the
patient to participate to the study or to comply with the study procedures or interfere
with interpretation of study results.

E 11. Absence of signed and dated Institutional Review Board (IRB)-approved patient
informed consent form prior to enrollment into the study.

E 12. Patients with reproductive potential who do not agree to use accepted and effective
method of contraception during the study treatment period. The definition of "effective
method of contraception" will be based on the Investigator's judgment. Patients' Partners
of childbearing potential (unless surgically sterile, post menopausal or for another
reason have no chance of becoming pregnant) not protected by highly effective
contraceptive method of birth control as defined for contraception in the Informed Consent
Form and /or in a local protocol addendum.

E 13. History of hypersensitivity to docetaxel, or polysorbate 80. E 14. Inadequate organ
and bone marrow function. E 15. Contraindications to the use of corticosteroid treatment.
E 16. 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:


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 6 years

Safety Issue:


Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

April 2011

Completion Date:

September 2017

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms



Investigational Site Number 840001Vallejo, California  94589
Investigational Site Number 840024Charlotte, North Carolina  28204
Investigational Site Number 840003Orlando, Florida  32806
Investigational Site Number 840008Los Angeles, California  90048
Investigational Site Number 840025Jackson, Tennessee  38305
Investigational Site Number 840013Boca Raton, Florida  33486
Investigational Site Number 840002Muscle Shoals, Alabama  35661
Investigational Site Number 840004Hot Springs, Arkansas  71913
Investigational Site Number 840010San Francisco, California  94143
Investigational Site Number 840021Stamford, Connecticut  06902
Investigational Site Number 840023Jacksonville, Florida  32256
Investigational Site Number 840007New Orleans, Louisiana  70112
Investigational Site Number 840014Baltimore, Maryland  21231
Investigational Site Number 840005Rockville, Maryland  20850
Investigational Site Number 840017St Louis Park, Minnesota  55416
Investigational Site Number 840011Jackson, Mississippi  39202
Investigational Site Number 840016Lincoln, Nebraska  68506
Investigational Site Number 840015East Orange, New Jersey  07018
Investigational Site Number 840020Akron, Ohio  44302
Investigational Site Number 840006Pawtucket, Rhode Island  02860
Investigational Site Number 840012Corpus Christi, Texas  78405