Cabazitaxel at 20 mg/m² Compared to 25 mg/m² With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer

Completed · Phase 3

Conditions studied: Prostate Cancer

In brief

Primary Objective: \- To demonstrate the non inferiority in term of overall survival (OS) of Cabazitaxel 20 mg/m² (Arm A) versus Cabazitaxel 25 mg/m² (Arm B) in combination with prednisone in participants with metastatic castration resistant prostate cancer (mCRPC) previously treated with a docetaxel-containing regimen. Secondary Objectives: * To evaluate safety in the 2 treatment arms and to assess if Cabazitaxel 20 mg/m² was better tolerated than Cabazitaxel 25 mg/m². * To compare efficacy of Cabazitaxel at 20 mg/m² and 25 mg/m² for: * Progression Free Survival (PFS) defined as the first occurrence of any of the following events: tumor progression per Response Evaluation Criteria In Solid Tumors (RECIST), prostate-specific antigen (PSA) progression, pain progression or death due to any cause; * PSA Progression; * Pain progression; * Tumor response in participants with measurable disease (RECIST 1.1); * PSA response; * Pain response in participants with stable pain at baseline. * To compare Health-related Quality of Life (HRQoL). * To assess the pharmacokinetics and pharmacogenomics of Cabazitaxel.

Key facts

Study ID

NCT01308580

Run by

Sanofi

People needed

1200

Starts

2011-04-01

Expected to finish

2015-08-01

Last updated by the study team

2017-04-17

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• I 01. Diagnosis of histologically or cytologically proven prostate adenocarcinoma, that was resistant to hormone therapy and previously treated with a docetaxel-containing regimen.
• I 02. Participant must had 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. Life expectancy > 6 months. I 05. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 - 2 (i.e, participant must be ambulatory, capable of all self-care, and up and about more than 50% of waking hours).
• I 06. Age ≥18 years (or country's legal age of majority if the legal age was > 18 years).

You may not qualify if…

• 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 had 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 were allowed, as well as any other cancer for which chemotherapy had been completed ≥ 5 years ago and from which the participant had 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 was also not allowed.
• E 10. Any severe acute or chronic medical condition which could impair the ability of the participant 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 participant informed consent form prior to enrollment into the study.
• E 12. Participants with reproductive potential who did not agree to use accepted and effective method of contraception during the study treatment period. The definition of "effective method of contraception" was based on the Investigator's judgment. Participant's Partners of childbearing potential (unless surgically sterile, post menopausal or for another reason had 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 (NCI CTCAE v.4.03).
• The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Where it is running

• Investigational Site Number 840004 — Hot Springs, Arkansas, United States
• Investigational Site Number 840008 — Anaheim, California, United States
• Investigational Site Number 840010 — La Jolla, California, United States
• Investigational Site Number 840001 — San Bernardino, California, United States
• Investigational Site Number 840021 — Stamford, Connecticut, United States
• Investigational Site Number 840023 — Jacksonville, Florida, United States
• Investigational Site Number 840013 — Lakeland, Florida, United States
• Investigational Site Number 840003 — Port Saint Lucie, Florida, United States
• Investigational Site Number 840007 — New Orleans, Louisiana, United States
• Investigational Site Number 840014 — Baltimore, Maryland, United States
• Investigational Site Number 840005 — Rockville, Maryland, United States
• Investigational Site Number 840017 — Saint Louis Park, Minnesota, United States
• Investigational Site Number 840011 — Jackson, Mississippi, United States
• Investigational Site Number 840016 — Lincoln, Nebraska, United States
• Investigational Site Number 840015 — East Orange, New Jersey, United States
• Investigational Site Number 840024 — Raleigh, North Carolina, United States
• Investigational Site Number 840020 — Akron, Ohio, United States
• Investigational Site Number 840006 — Pawtucket, Rhode Island, United States
• Investigational Site Number 840025 — Chattanooga, Tennessee, United States
• Investigational Site Number 840012 — Corpus Christi, Texas, United States
• Investigational Site Number 032002 — Buenos Aires, Argentina
• Investigational Site Number 032001 — Rosario, Argentina
• Investigational Site Number 032003 — Salta, Argentina
• Investigational Site Number 032004 — Santa Fe, Argentina
• Investigational Site Number 840002 — Muscle Shoals, Alabama, United States

Full record on ClinicalTrials.gov

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