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Study Summary
No. 2006-0700:.......Genitourinary......Eric Jonasch......Genitourinary Medical Oncology
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Study Summary Title
Study Summary
Number:
2006-0700
Study Title: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.
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Physician New Patient Referral
Name:Eric JonaschPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Genitourinary Medical OncologyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-2830
Contact us about clinical trials
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General Information
Disease Group:GenitourinarySupported By:N/A
Phase of Study:Phase IIReturn
Visit:
Participants will return to clinic every 2 weeks for dosing and assessment.
Treatment
Agents:
AMG 102Home Care:N/A
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
The goal of this clinical research study is to learn if the study drug AMG 102
can help to control the disease in patients with advanced renal cell
carcinoma. The safety of the study drug will also be studied.
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Study Objectives / Outcomes
Primary
  • To assess objective response rate in subjects with advanced renal cell carcinoma receiving AMG 102 treatment
Secondary
  • 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

Safety
  • To assess the safety of AMG 102 in subjects with advanced renal cell carcinoma.

Exploratory
  • To explore the pharmacodynamic tumor response of AMG 102 as assessed by
    HGF/c-Met pathway markers, tumor apoptosis markers and other biomarkers.
  • To investigate the effects of disease genes (ie, cancer), drug target genes and
    other biomarkers on subject response to AMG 102. (This part of the study is
    optional and requires a separate consent.)
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Study Status Information
Study Activation / Registration Date:08/20/2007
IRB Review and Approval Date:08/20/2007
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Terminated
Projected Accrual:approximately 80
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Documented histologically confirmed advanced or metastatic renal cell carcinoma with the primary tumor in place or following nephrectomy

2) Measurable disease, defined as >/= 1 unidimensionally measurable lesion >/= 20 mm by conventional techniques (CT or MRI) or >/= 10 mm by spiral CT scan

3) No more than 3 relapses or prior systemic treatments

4) Unable or ineligible 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

5) 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)

6) Age >/= 18 years

7) ECOG performance status of 0-2

8) Hemoglobin concentration >/= 9 g/dL

9) Absolute neutrophil count >/= 1.5 x 10^9/L

10) Platelet count >/= 100 X 10^9/L

11) Corrected serum calcium </= 10 mg/dL

12) Either serum creatinine < 2.0 X upper limit of normal OR creatinine clearance > 40 mL/min

13) 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

14) Serum total bilirubin </= 2.5 times upper limit of normal

15) Before any study-specific procedure, the appropriate written informed consent must be obtained

Exclusion Criteria:1) 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

2) Concurrent severe and/or uncontrolled medical disease (eg, uncontrolled diabetes, Class III or IV congestive cardiac failure as defined by the New York Heart Association, myocardial infarction within 6 months before enrollment) that could compromise participation in the study

3) Uncontrolled severe hypertension (>= 140/90 despite controlling medication)

4) Documented history of human immunodeficiency virus infection

5) Documented history of viral chronic hepatitis

6) Received biologic, small molecule, immunotherapy, chemotherapy, radiotherapy or other agents to treat renal cancer within 28 days before enrollment

7) Treated previously with any c-Met or HGF targeted therapy

8) Concurrent or prior (within 7 days before enrollment) anticoagulation therapy, unless: a) 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 b) Subject does not have a history of clinically significant bleeding or bruising while on anticoagulants

9) 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.

10) Concurrent palliative or therapeutic radiation therapy

11) 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)

12) Active infection requiring treatment within 1 week before enrollment

13) Undergone major surgery within 4 weeks before enrollment or recovering from prior surgery

14) 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

15) Known allergy or sensitivity to any of the excipients in the investigational product to be administered

16) Pregnant or is breast feeding

17) 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

18) Previously treated with AMG 102

19) Previously enrolled into this study

20) Will not be available for follow-up assessments

21) Has other disorders that compromises the ability of the subject to give written informed consent and/or comply with study procedures

22) Unable to begin protocol specified treatment within 3 days after enrollment

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Links
Registration Number: NCT00422019
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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