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A Global, Multicenter, Open-label, Single Agent, Two-stage Phase 2 Study to Evaluate the Efficacy and Safety of AMG 102 in Subjects With Advanced Renal Cell Carcinoma

Phase 2
18 Years
Not Enrolling
Advanced Renal Cell Carcinoma

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Trial Information

A Global, Multicenter, Open-label, Single Agent, Two-stage Phase 2 Study to Evaluate the Efficacy and Safety of AMG 102 in Subjects With Advanced Renal Cell Carcinoma

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

- 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

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,

- 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

- active infection requiring treatment within 1 week before enrollment

- undergone major surgery within 4 weeks before enrollment or recovering from prior

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the objective response rate in subjects with advanced renal cell carcinoma receiving AMG 102 treatment

Outcome Time Frame:

9 weeks from first dose of AMG 102

Safety Issue:


Principal Investigator


Investigator Role:

Study Director

Investigator Affiliation:



Belgium: FPS of Public Health, Food Chain Security and Environment

Study ID:




Start Date:

January 2007

Completion Date:

March 2009

Related Keywords:

  • Advanced Renal Cell Carcinoma
  • Renal Cancer
  • Kidney Cancer
  • Carcinoma
  • Carcinoma, Renal Cell