A Phase II Study to Treat Subjects With Advanced Renal Cell Carcinoma

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness and safety of AMG 102 in patients with Advanced Renal Cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Antibodies, Monoclonal; Dihydrotachysterol; Rilotumumab

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 systemic treatments)

• unable 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

• ECOG performance status of 0-2

• hemoglobin concentration ≥ 9 g/dL

• absolute neutrophil count ≥ 1.5 x 10(9th)/L

• corrected serum calcium ≤ 10 mg/dL

• either serum creatinine < 2.0 x upper limit of normal OR creatinine clearance > 40 mL/min

• alanine aminotransferase ≤ 2.5 times upper limit of normal or < 5.0 x ULN if the subject has documented liver metastasis or primary hepatic neoplasm

• serum total bilirubin ≤ 2.5 times upper limit of normal

• before any study-specific procedure, the appropriate written informed consent must be obtained

Exclusion Criteria:

• 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 (e.g., 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

• received biologic, small molecule, immunotherapy, chemotherapy, radiotherapy or other agents to treat renal cancer within 28 days before enrollment

• treated previously with c-Met or HGF targeted therapy

• concurrent or prior (within 7 days before enrollment) anticoagulation therapy, except:

• Use of low-dose warfarin (< 2 mg/day) for prophylaxis against central venous catheter thrombosis or

• Use of low molecular weight heparins (LMWH, e.g., enoxaparin sodium [Lovenox] and unfractionated heparin for prophylaxis against central venous catheter thrombosis is allowed

• concurrent use of hormones or other chemotherapeutic agents except for steroids given for adrenal failure and hormones administered for non-disease-related conditions (eg, insulin for diabetes); except for non-cancer reasons

• concurrent palliative or therapeutic radiation therapy

• 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 non-melanoma 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 not post-menopausal (no menstrual period for a minimum of 12 months at study entry) or documented surgically sterile will not be bound to this exclusion

• 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