A Phase 1 Study of the Safety and Pharmacokinetics of AGS-16M18 in Subjects With Advanced Renal Cell Cancer

February 26, 2013 updated by: Astellas Pharma Inc

A Phase 1, Open-Label, Multi-center, Dose Escalation Study of the Safety and Pharmacokinetics of AGS-16M18 Given as Monotherapy in Subjects With Advanced Renal Cell Carcinoma

This is a first in human study of AGS-16M18 given every week to subjects with advanced renal cell cancer. AGS-16M18 will be administered as a 60 minute IV infusion on consecutive days until the disease worsens.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Subjects will be enrolled sequentially into 5 planned dose cohorts according to a standard, dose escalation study design. A disease assessment will be performed at study week 5 (+/- 3 days) by the investigator. The assessment will be based both on changes in clinical symptoms, and radiographic images. Subjects without evidence of disease progression may receive AGS-16M18 extended therapy at the dose and schedule of their assigned cohort until disease progression or intolerability of AGS-16M18. Disease assessments will be performed every 8 weeks during the extended period. A safety follow-up visit will occur 4 weeks after the last infusion of AGS-16M18.

Study Type

Interventional

Enrollment (Actual)

7

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
    • Maryland
      • Baltimore, Maryland, United States, 21231
    • New York
      • New York, New York, United States, 10021

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 amendable to cure by surgery or other means, and must have failed at least one prior systemic therapy, including but not limited to treatment with sunitinib, temsirolimus or sorafenib
  • Evaluable/Measureable disease according to Response Criteria for Solid tumors
  • Eastern Cooperative Group performance status of 0-1
  • Therapeutic anti-coagulation (PT, and/or INR, PTT) permitted, if clinically stable and >/= 3 months from initiation

Exclusion Criteria:

  • Past or present documented central nervous system (CNS) tumor or CNS metastasis
  • Use of investigational drug (including marketed drugs not approved for this indication) within 4 weeks prior to screening or 5 half-lives of the prior investigational drug (whichever is longer)
  • History of thromboembolic events and bleeding disorders </= 3 months (e.g., DVT or PE)
  • Major Surgery (that requires general anesthesia) within 4 weeks of study enrollment

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1. AGS-16M18 Dose 1
Biological: AGS-16M18
IV Infusion
EXPERIMENTAL: 2. AGS-16M18 Dose 2
Biological: AGS-16M18
IV Infusion
EXPERIMENTAL: 3. AGS-16M18 Dose 3
Biological: AGS-16M18
IV Infusion
EXPERIMENTAL: 4. AGS-16M18 Dose 4
Biological: AGS-16M18
IV Infusion
EXPERIMENTAL: 5. AGS-16M18 Dose 5
Biological: AGS-16M18
IV Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events
Time Frame: Throughout the treatment
Throughout the treatment
Assessment of PK variables
Time Frame: Weeks 0 - 5, week 8, weekly during extension period, 2 and 3 months after last dose
Weeks 0 - 5, week 8, weekly during extension period, 2 and 3 months after last dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of anti-AGS-16M18 antibody formation
Time Frame: Week 0, week 1, week 4, week 8, every 8 weeks during extension period, 2 and 3 months after last dose
Week 0, week 1, week 4, week 8, every 8 weeks during extension period, 2 and 3 months after last dose
Changes in tumor status
Time Frame: Week 5, week 8, every 8 weeks during extension period
Week 5, week 8, every 8 weeks during extension period

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: Use Central Contact, Agensys, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

October 1, 2008

Primary Completion (ACTUAL)

April 1, 2010

Study Completion (ACTUAL)

April 1, 2010

Study Registration Dates

First Submitted

January 1, 2009

First Submitted That Met QC Criteria

January 2, 2009

First Posted (ESTIMATE)

January 5, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 27, 2013

Last Update Submitted That Met QC Criteria

February 26, 2013

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007002

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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