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)
- Conditions
- Metastatic Hormone-Refractory Prostate Cancer (HRPC)MedDRA version: 8.1Level: LLTClassification code 10062904Term: Hormone-refractory prostate cancer
- Registration Number
- EUCTR2006-001671-38-DE
- Lead Sponsor
- Centocor B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 134
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
castration
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
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
screening.
2. Known CNS metastases.
3. Received any investigational drug/agent within 30 days or 5 half-lives, whichever
is longer.
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
study.
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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of Part 2 of the trial is to compare CNTO 328 in combination with mitoxantrone vs mitoxantrone with respect to the PFS of subjects with metastatic HRPC who have received only one prior docetaxel-based chemotherapy regimen.;Secondary Objective: The secondary objectives of Part 2 are to evaluate and compare safety and other efficacy endpoints of CNTO 328 in combination with mitoxantrone versus mitoxantrone in subjects with metastatic HRPC who have received only one prior<br>docetaxel-based chemotherapy regimen. <br>In addition, pharmacodynamic biomarker and health outcomes responses will be evaluated.;Primary end point(s): The primary endpoints are safety for Part 1, and PFS (Progression Free Survival) for Part 2.
- Secondary Outcome Measures
Name Time Method