Advanced Renal Cell Carcinoma MedDRA version: 8.1 Level: LLT Classification code 10050513 Term: Metastatic renal cell carcinoma
Conditions
Interventions
Product Name: AMG 102
Product Code: AMG 102
Pharmaceutical Form: Solution for infusion
Current Sponsor code: AMG 102
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concent
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - documented histologically confirmed advanced or metastatic renal cell carcinoma with the primary tumor in place or following nephrectomy - measurable disease, defined as = 1 unidimensionally measurable lesion = 20 mm by conventional techniques (CT or MRI) or = 10 mm by spiral CT scan - no more than 3 relapses (or prior systememic treatments) - unable or ineligibile to receive or failed prior therapy with vascular endothelial growth factor (VEGF) binding agents or VEGF receptor tyrosine kinase inhibitors or other multi-kinase inhibitors - tissue blocks or tissue sections from initial or upon diagnosis of advanced metastatic disease are available for submission to the central laboratory within approximately 4 weeks after enrollment or approval is granted by the sponsor (upon receipt of justification why the sample is not available) -age=18 years - EGOC performance status of 0-2 - haemoglobin concentration =9g/dL - absolute neutrophil count =1.5 x 109/L -platelet count =100 x 109/L -corrected serum calcium less than or equal to 10 mg/dL - either serum creatinine 40 mL/min -alanine aminotransferase less than or equal to 2.5 x ULN or > 5.0 x ULN if the subject has documented liver metastasis or primary hepatic neoplasm. -serum total bilirubin less than or equal to 2.5 x ULN. -before any study-specific procedure, the appropriate written informed consent must be obtained 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
Exclusion criteria: Disease Related: - active brain metastases; brain metastases allowed provided they have been treated with surgery and/or radiation therapy and show no evidence of progression on cerebral CT or MRI scan 2 months following surgery and/or radiation therapy - concurrent severe and/or uncontrolled medical disease (eg, uncontrolled diabetes, congestive cardiac failure, myocardial infarction within 6 months before enrollment) that could compromise participation in the study - documented history of human immunodeficiency virus infection - documented history of viral chronic hepatitis Medications: - received biologic, small molecule, immunotherapy, chemotherapy, radiotherapy or other agents to treat renal cancer within 4 weeks before enrollment - treated previously with c-Met or HGF targeted therapy - concurrent or prior (within 7 days of enrollment ) anticoagulation therapy, unless: Subject has an INR value of between 2.0 and 3.0 while on a stable dose of a coumarin-type anticoagulant for at least 30 days prior to enrollment, and Subject does not have a history of clinically significant bleeding or bruising while on anticoagulants - concurrent use of hormones or other chemotherapeutic agents except for steroids given for adrenal failure and hormones administered for nondisease- related conditions (eg, insulin for diabetes); except for non-cancer reasons. - concurrent palliative or therapeutic radiation therapy General: - currently enrolled in or has not yet completed at least 30 days since ending other investigational device or therapy, or subject is receiving other investigational agent(s) - active infection requiring treatment within 1 week before enrollment - undergone major surgery within 4 weeks before enrollment or recovering from prior surgery - past or current history of another neoplasm, except for curatively treated nonmelanoma skin cancer, carcinoma in situ of the cervix and other primary solid cancer with no known active disease present and no curative treatment administered for the last 3 years - known allergy or sensitivity to any of the excipients in the investigational product to be administered - pregnant or is breast feeding - not consenting to use adequate contraceptive precautions during the course of the study and for 6 months after the last administration of investigational product - female subjects who are post menopausal (no menstrual period for a minimum of 12 months at study entry) or documented surgically sterile will not be bound to this requirement - previously treated with AMG 102 - previously enrolled into this study - will not be available for follow-up assessments - has other disorders that compromises the ability of the subject to give written informed consent and/or comply with study procedures - unable to begin protocol specified treatment within 3 days after enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess objective response rate in subjects with advanced renal cell carcinoma receiving AMG 102 treatment.;Secondary Objective: • To estimate the overall survival and progression-free survival rates in this population • To assess duration of response and time to response in this population • To assess the pharmacokinetics of AMG 102 in subjects with advanced renal cell carcinoma.;Primary end point(s): objective response rate | — |
Countries
Belgium
Outcome results
None listed