EUCTR2006-001671-38-BEActive, not recruitingNot Applicable
A Phase 2 Multicenter, Open-label Study of CNTO 328 (Anti-IL-6 Monoclonal Antibody) in Combination with Mitoxantrone versus Mitoxantrone in Subjects with Metastatic Hormone-Refractory Prostate Cancer (HRPC)
Centocor B.V.0 sites134 target enrollmentStarted: October 25, 2006Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 134
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Male
Inclusion Criteria
- •To be eligible for the study, subjects must meet all of the following criteria:
- •1. Males aged = 18 years
- •2. Signed informed consent obtained prior to any study-specific screening procedures
- •3. Histologically or cytologically confirmed adenocarcinoma of the prostate
- •4. Radiologically documented metastatic disease
- •5. At least 6 weeks of treatment with one prior docetaxel-based chemotherapy regimen for metastatic HRPC
- •6. Disease progression, during or within 6 months of cessation of prior docetaxel-based therapy, based on one of the following:
- •a. Serum PSA progression, defined as a rise in at least 2 consecutive serum PSA values, each obtained at least 1 week apartor
- •b. Radiologic disease progression: If disease progression is shown by bone
- •scan only, then disease progression is defined by the appearance of 2 or
- •more new bone lesions
- •7. Orchiectomy or testosterone < 50 ng/dL by means of pharmacological/chemical
- •8. At least 4 weeks from prior anti-cancer therapy
- •9. ECOG = 2
- •10. Screening laboratory values for study entry:
- •a. WBC count = 3.0 x 109 /L and absolute neutrophil count (ANC)
- •= 1.5 x 109/L
- •b. Hemoglobin = 9.0 g/dL
- •c. Platelet count = 100 x 109/L
- •d. AST and ALT = 2.5 x ULN
- •e. Bilirubin = 1.5 x ULN
- •f. Creatinine = 1.5 x ULN
- •11. LVEF = 50%
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Subjects meeting any of the following criteria may not be enrolled in the study:
- •1. Prostate cancer that does not express PSA or PSA level is < 5.0 ng/mL at
- •2. Known CNS metastases.
- •3. Received any investigational drug/agent within 30 days or 5 half-lives, whichever
- •4. Received more than one line of systemic chemotherapy for metastatic HRPC.
- •5. Prior mitoxantrone treatment for HRPC.
- •6. Prior malignancy (other than prostate cancer) except 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 = 3 years.
- •7. Known HIV seropositivity or known hepatitis B or C infection.
- •8. Planned major surgery during the study.
- •9. Received any mAb within 60 days of first dose of study agent.
- •10. Serious concurrent illness or significant cardiac disease characterized by
- •significant ischemic coronary disease, significant arrhythmias, or congestive heart
- •failure (= New York Heart Association (NYHA) II; Appendix B) or myocardial
- •infarction within the past 6 months.
- •11. 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
- •12. Therapy with bisphosphonates initiated < 6 weeks prior to first administration of CNTO 328.
- •13. Transfusion dependent anemia
- •14. Vaccinated with live, attenuated vaccines within 4 weeks of the first administration of CNTO 328. Inactivated injectable influenza vaccine is permitted.
- •15. Known allergies or clinically significant reactions to murine, chimeric, or human proteins.
- •16. Medical history suggesting compromised bone marrow (eg, recurrent febrile-neutropenia, neutropenic infection, multiple dose delay during prior docetaxel treatment, or required use of granulocyte colonystimulating factor [G-CSF] or granulocyte-macrophage colony-stimulating factor [GM-CSF] to meet study entry criteria).
Investigators
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