Metastatic Castrate-Resistant Prostate Cancer MedDRA version: 13.1 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: CNTO888
Product Code: CNTO888
Pharmaceutical Form: Powder for solution for infusion
Current Sponsor code: CNTO 888
Other descriptive name: anti-CCL2 Monoclonal Antibody
Concentration uni
Sponsors
Janssen Biologics B.V.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Potential subjects must satisfy all of the following criteria to be enrolled in the study: • Male age = 18 years • Sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. • Histological documentation of adenocarcinoma of the prostate • Received at least 1 but no more than 2 prior docetaxel-based chemotherapy regimens and had disease progression following the last therapy. Disease progression is defined as: – Serum PSA progression, defined as a rise in at least 2 consecutive serum PSA values, each obtained at least 1 week apart, and within 4 weeks prior to first dose of study agent (see Attachment 4) OR – 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 • Serum PSA = 5.0 ng/mL within 4 weeks prior to the first dose of study agent • Orchiectomy or testosterone =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Potential subjects who meet any of the following criteria will be excluded from participating in the study: • Experiences a hormonal treatment withdrawal response (including a lowering of PSA that was previously rising or symptomatic improvement) • Known or symptomatic CNS metastases • Residual toxicities resulting from previous therapy that are = Grade 2 (except for alopecia) • Known allergies, hypersensitivity, or intolerance to CNTO 888 or its excipients (refer to Section 14.1, Physical Description of Study Drug) or clinically significant reactions to chimeric or human proteins • Vaccinated with live, attenuated vaccines within 4 weeks prior to the first dose of study agent. Inactivated, injectable or inhaled influenza vaccine is permitted • Bleeding diathesis • Requires concurrent therapeutic dose of anticoagulation (low-dose prophylaxis is permitted) • Bisphosphonate therapy initiated < 6 weeks prior to the first dose of study agent or that required dose adjustment during this time • Treatment with systemic cancer therapy, herbal treatments, over-the-counter treatments for prostate cancer, or local radiotherapy within 4 weeks prior to the first dose of study agent – Palliative radiotherapy (eg, for pain, fracture prevention) to control a small area of metastatic bone disease may be permitted if the subject has recovered from the effects of the radiotherapy • Received an investigational drug/agent (including vaccines) or used an investigational medical device within 4 weeks prior to the first dose of study agent or are currently enrolled in an investigational study • Concomitant treatment such as, immunotherapy, biotherapy, radiotherapy, chemotherapy, investigative therapy, or new steroid therapy (except for topical or inhaled steroids, or unless clinically indicated [eg, for asthmatic attacks, reactions to IV contrast, allergic reactions that develop during the study, severe nausea, vomiting]). The following exceptions apply: – Subjects on stable doses of steroids for treatment of noncancerous conditions will be allowed to continue on the steroid therapy during the study only if maintained at the same dose (ie, the dose may not be increased during this study). – Luteinizing Hormone Releasing Hormone (LHRH) is permitted provided the subject is on a stable dose prior to screening • Prior use of radionucleotide therapy (eg, Strontium89, Samarium) • Use of disallowed therapies: Non-steroidal antiandrogens (flutamide, bicalutamide, or nilutamide) or other hormonal treatments (such as estramustine or ketoconazole), within 6 weeks prior to the first dose of study agent or as concomitant medication • Requires transfusion of blood products to meet eligibility criteria, or within 4 weeks prior to the collection of screening hematology laboratory sample • Uncontrolled infection, clinically important active infection within 4 weeks prior to the first dose of study agent, or currently receiving treatment for an infection • Major surgery within 4 weeks prior to the first dose of study agent, or planning to have surgery (except for minor surgical procedures) during the study, or planned major surgery within 8 weeks after the last dose of study agent • Serious concurrent illness (medical or psychiatric), altered mental status (eg, dementia) or any uncontrolled medical condition (eg, uncontrolled diabetes), including the presence of laboratory abnormali
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine the composite response (measured by change from baseline in skeletal lesions, extra-skeletal lesions, and PSA values) in subjects with metastatic CRPC who receive single-agent 15 mg/kg CNTO 888 IV formulation, administered as a 90-minute infusion once every 2 weeks. ;Secondary Objective: The secondary objectives are to evaluate further clinical and additional biological activity of single-agent CNTO 888 in subjects with metastatic CRPC, including the following endpoints: • Objective response rate (complete response [CR] +PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines • Progression-free survival (PFS) • Overall survival (OS) • PSA response • Urinary crosslinked N-telopeptide of type I collagen (NTX) response • Pain response • Safety profile • Biological activity (defined by changes in macrophage infiltration, monocyte subsets M1/M2, CCL2 levels in tumor, blood, and serum and urinary bone markers) • Pharmacokinetics • Pharmacodynamics • Antibodies to CNTO 888 ;Primary end point(s): The primary endpoint is the composite response rate, measured by change from baseline in skeletal lesions, extra-skeletal lesions, and PSA values. The composite response rate will be estimated and its 2-sided exact 95% confidence interval will be computed. A subject has a composite response if 1 of the following responses occurs after the first dose of study agent: • CR or PR according to RECIST criteria • PSA response at 12 weeks and the absence of skeletal and extra-skeletal progression • Stable disease at 24 weeks defined as the absence of PSA, skeletal, or extra-skeletal progression | — |
Countries
Belgium, United Kingdom
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International
Outcome results
None listed