A study where CNTO888 (an anti-CCL2 Monoclonal Antibody) is used to treat subjects with Metastatic Castrate-Resistant Prostate Cancer.

• Conditions: Metastatic Castrate-Resistant Prostate Cancer; MedDRA version: 13.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2009-011251-48-GB
• Lead Sponsor: Janssen Biologics B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 43

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 < 50 ng/dL by means of pharmacological/chemical castration within 4 weeks prior to the first dose of study agent
• At least 6 weeks from prior docetaxel chemotherapy regimen to first dose of study agent
• ECOG performance status score of = 2 (see Attachment 3)
• Adequate bone marrow, liver, and renal function within 2 weeks prior to the first dose of study agent as described below:
– Hemoglobin = 9.0 g/dL (5.6 mmol/L; 90 g/L) without transfusion dependency or erythropoiesis-stimulating agents
– Absolute neutrophil count (ANC) = 1.0 x 109/L (1000/mm3) without hematopoietic cytokine support
– Platelets = 100 x 109/L (100,000/mm3) without transfusion dependency or hematopoietic cytokine support
– Coagulation prothrombin time (PT) or international normalized ratio (INR), and activated partial thromboplastin time (aPTT) = 1.5 x ULN
– AST and ALT = 3 x ULN if no liver metastasis; = 5 x ULN with liver metastasis
– Total bilirubin = 1.5 x ULN
– Serum creatinine = 1.5 x ULN
• Men must agree to use a double barrier method of birth control and to not donate sperm during the study and for 6 months after receiving the last dose of study drug.
• Willing/able to adhere to the prohibitions and restrictions specified in this protocol
• To participate in the optional pharmacogenomic component of this study, subjects must have signed the informed consent form for pharmacogenomic research indicating willingness to participate in the pharmacogenomic component of the study (where local regulations permit). Refusal to give consent for this component does not exclude a subject from participation in the clinical study.
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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified