A Randomized, Double-blind, Multicenter, Phase 2 Study of a Human Monoclonal Antibody to Human aV Integrins (CNTO 95) in Combination With Docetaxel and Prednisone for the First-Line Treatment of Subjects With Metastatic Hormone Refractory prostate Cancer - C1034T08

Janssen-Cilag0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年5月13日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Janssen-Cilag
入组人数: 20

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 99（—）

入选标准

•1. Are male >= 18 years of age.
•2. Have histologically or cytologically confirmed adenocarcinoma of the prostate.
•3. Have radiologic or clinical evidence of metastatic disease.
•4. Have progressive hormone-refractory disease after orchiectomy or gonadotropinreleasing
•hormone analog and/or antiandrogen treatment within 6 months prior to
•the first study agent administration, documented by at least 1 of the following:
•a. Transaxial imaging (CT or MRI) tumor progression
•b. Rise in 2 consecutive PSA values obtained at least 14 days apart
•c. Radionucleotide bone scan with at least 2 new lesions
•5. Have an ECOG score <= 2.
•6. Have adequate bone marrow, liver, and renal function, defined as follows:
•a. Absolute neutrophil count (ANC) >= 1.5 × 109/L
•b. Hemoglobin >= 10 g/dL (without transfusion)
•c. Platelets >= 100 × 109/L
•d. AST and ALT < 2.5 × ULN
•e. Alkaline phosphatase < 5 × ULN
•f. Total bilirubin within normal limits
•g. Creatinine <= 1.5 mg/dL
•h. Activated partial thromboplastin time (aPTT) and prothrombin time (PT)
•<= 1.5 × ULN
•7. Have testosterone < 50 ng/mL for subjects without surgical castration.
•Testosterone level will not be documented for subjects who have been surgically
•8. Have serum PSA >= 5.0 ng/mL.
•9. Have a life expectancy > 12 weeks.
•10. Have at least 4 weeks from previous major surgery to date of first study agent
•administration. Subjects must have recovered or stabilized from previous surgery.
•11. Have discontinued flutamide > 4 weeks prior to the first study agent
•administration, or have discontinued nilutamide or bicalutamide > 6 weeks prior
•to the first study agent administration.
•12. Use appropriate contraception (eg, condom) for the duration of the study and for 3 months after the last study treatment.
•13. Provide signed and dated informed consent(s) prior to any study-specific
•procedures and agree to comply with all protocol-specified procedures.

排除标准

•1. Have known CNS metastases.
•2. Had prior systemic nonhormonal therapy for HRPC.
•3. Received any investigational drug/agent within 30 days or 5 half-lives, whichever
•4. Had a prior malignancy (other than prostate cancer) except for adequately treated
•superficial bladder cancer, basal cell or squamous cell carcinoma of the skin, or
•other cancer for which the subject has been disease-free for >= 5 years.
•5. Have known HIV seropositivity or known hepatitis B or C infection.
•6. Have planned major surgery during the study.
•7. Had prior radiotherapy to > 25% of the marrow-containing skeleton.
•8. Have peripheral neuropathy > Grade 1.
•9. Have a history of uveitis.
•10. Have taken any over-the-counter or herbal treatment for prostate cancer within
•4 weeks prior to the first study agent administration.
•11. Have a serious concurrent illness or significant cardiac disease characterized by
•significant ischemic coronary disease, significant arrhythmias (requiring active
•treatment), or congestive heart failure New York Heart Association (>= NYHA II)
•or myocardial infarction within the previous 6 months.
•12. Have any uncontrolled medical condition, serious infection, or the presence of
•clinically significant laboratory abnormalities that places the subject at
•unacceptable risk by participating in the study or confounds the ability to interpret
•data from the study.
•13. Requires hematopoietic growth factors or transfusion of blood products to meet
•eligibility criteria.
•14. Had prior use of radionucleotide therapy (eg, Strontium89, Samarium).
•15. Undergoing concurrent immunotherapy, biotherapy, radiotherapy, investigational
•therapy, or steroid therapy other than that included in this protocol (except for
•topical or inhaled steroids, or unless clinically indicated [eg, for reactions to IV
•contrast, allergic reactions that develop during the study, severe nausea,
•vomiting]).
•16. Requires concurrent anticoagulation therapy (except for low-dose prophylaxis).
•17. Have known hypersensitivity to docetaxel or its components.
•18. Have a history of anaphylaxis or severe allergic reaction(s) to human Ig therapy
•or polysorbate 80 (formulation components of CNTO 95).
•19. Has history of bleeding diathesis.
•20. Had recurrent arterial or venous thromboembolism within 6 months preceding
•enrollment.

研究者

发起方

Janssen-Cilag

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