A First in Man Study to Determine the Safety at Various Dose Levels of AGS-16M8F in Advanced Kidney Cancer
NCT ID: NCT01114230
Last Updated: 2012-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
26 participants
INTERVENTIONAL
2010-08-31
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dose Level 1
AGS-16M8F
IV
Dose Level 2
AGS-16M8F
IV
Dose Level 3
AGS-16M8F
IV
Dose Level 4
AGS-16M8F
IV
Dose Level 5
AGS-16M8F
IV
Dose Level 6
AGS-16M8F
IV
Dose Level 7
AGS-16M8F
IV
Dose Level 8
AGS-16M8F
IV
Dose Level 9
AGS-16M8F
IV
Interventions
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AGS-16M8F
IV
Eligibility Criteria
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Inclusion Criteria
* Non-measurable or measurable disease according to Response Criteria for Solid Tumors (RECIST Version 1.1)
* Eastern Cooperative Group (ECOG) performance status of 0-1
* Negative pregnancy test (women of childbearing potential)
* Hematologic function, as follows:
* Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
* Platelet count ≥ 100 x 109/L
* Hemoglobin ≥ 9 g/dL (transfusions are allowed)
* Renal function, as follows:
* creatinine ≤ 1.5 x upper limit of normal (ULN), or calculated glomerular filtration rate (GFR) \> 50 mL/min if creatinine \> 1.5x ULN
* Hepatic function, as follows:
* Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x ULN or ≤ 5x ULN if known liver metastases
* Total bilirubin ≤ 1.5 x ULN
* International Normalized Ratio (INR) \< 1.3 (or ≤ 3.0 if on therapeutic anticoagulation)
* Women and men of childbearing potential must be advised and agree to practice effective methods of contraception during the course of the study and for four weeks after the last AGS-16M8F infusion administration
Exclusion Criteria
* Use of any investigational drug (including marketed drugs not approved for this indication) within 4 weeks prior to screening
* History of thromboembolic events and bleeding disorders ≤ 3 months (e.g., DVT or PE)
* Active angina or Class III or IV Congestive Heart Failure (New York Heart Association CHF Functional Classification System) or clinically significant cardiac disease within 12 months of study enrollment, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, congestive heart failure, uncontrolled hypertension, or arrythmias not controlled by outpatient medication
* Major surgery (that requires general anesthesia) within 4 weeks of study enrollment
* Women who are pregnant (confirmed by positive pregnancy test) or lactating
* Known positive test for human immunodeficiency virus (HIV), hepatitis C, or hepatitis B surface antigen
* Active infection requiring treatment with systemic (intravenous or oral) anti-infectives (antibiotic, antifungal, or antiviral agent) within 72 hours of screening
18 Years
ALL
No
Sponsors
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Agensys, Inc.
INDUSTRY
Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Chief Medical Officer
Role: STUDY_DIRECTOR
Agensys, Inc.
Locations
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Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Countries
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Other Identifiers
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2009002
Identifier Type: -
Identifier Source: org_study_id