A First in Man Study to Determine the Safety at Various Dose Levels of AGS-16M8F in Advanced Kidney Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01114230
Recruitment Status : Completed
First Posted : May 3, 2010
Last Update Posted : December 12, 2012
Agensys, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
The purpose of this dose escalation study is to examine the safety and pharmacokinetics (PK) of AGS-16M8F administered in subjects with advanced renal cell carcinoma.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Pharmacokinetics of AGS-16M8F Drug: AGS-16M8F Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-label, Multi-center, Dose Escalation Study of the Safety and Pharmacokinetics of AGS-16M8F Monotherapy in Subjects With Advanced Renal Cell Carcinoma
Study Start Date : August 2010
Primary Completion Date : November 2012
Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Dose Level 1 Drug: AGS-16M8F
Experimental: Dose Level 2 Drug: AGS-16M8F
Experimental: Dose Level 3 Drug: AGS-16M8F
Experimental: Dose Level 4 Drug: AGS-16M8F
Experimental: Dose Level 5 Drug: AGS-16M8F
Experimental: Dose Level 6 Drug: AGS-16M8F
Experimental: Dose Level 7 Drug: AGS-16M8F
Experimental: Dose Level 8 Drug: AGS-16M8F
Experimental: Dose Level 9 Drug: AGS-16M8F

Primary Outcome Measures :
  1. Safety assessed by recording adverse events, vital signs and laboratory assessments [ Time Frame: For 12 weeks during treatment period and up to 4 weeks follow up ]
  2. Pharmacokinetic variables assessment through analysis of blood samples [ Time Frame: Up to day 15 for cycle 1 and cycle 4 and pre-dose for cycles 2 and 3; every 3 weeks during the second 12 weeks of treatment; and if subject continues on study drug, every 12 weeks thereafter ]

Secondary Outcome Measures :
  1. Incidence of anti-AGS-16M8F antibody formation [ Time Frame: Baseline; up to day 64 during the first 12 weeks; and if subject continues on study drug, every 3 weeks during the second 12 weeks of treatment and every 12 weeks thereafter ]
  2. Incidence of Tumor Response (complete or partial response) [ Time Frame: Baseline and every 12 weeks while on study drug ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologic or cytologic diagnosis (recent or remote) of metastatic renal cell carcinoma (including papillary, clear cell, and excluding transitional cell types) that is not amenable to cure by surgery or other means.
  • 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:

  • Past or present documented central nervous system (CNS) tumor or CNS metastasis
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01114230

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Astellas Pharma Inc
Agensys, Inc.
Study Director: Chief Medical Officer Agensys, Inc.

Responsible Party: Astellas Pharma Inc Identifier: NCT01114230     History of Changes
Other Study ID Numbers: 2009002
First Posted: May 3, 2010    Key Record Dates
Last Update Posted: December 12, 2012
Last Verified: December 2012

Keywords provided by Astellas Pharma Inc:
Advanced Renal Cell Carcinoma
Advanced Kidney Cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases