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

December 10, 2012 updated by: Astellas Pharma Inc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan Kettering Cancer Center
    • Washington
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
For 12 weeks during treatment period and up to 4 weeks follow up
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
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

Outcome Measure
Time Frame
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
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
Incidence of Tumor Response (complete or partial response)
Time Frame: Baseline and every 12 weeks while on study drug
Baseline and every 12 weeks while on study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Collaborators

Agensys, Inc.

Investigators

  • Study Director: Chief Medical Officer, Agensys, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

April 29, 2010

First Submitted That Met QC Criteria

April 30, 2010

First Posted (Estimate)

May 3, 2010

Study Record Updates

Last Update Posted (Estimate)

December 12, 2012

Last Update Submitted That Met QC Criteria

December 10, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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