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

This study has been terminated.
(Trial was terminated due to the need to re-formulate the study drug.)
Sponsor:
Collaborator:
Agensys, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00816686
First received: January 1, 2009
Last updated: February 26, 2013
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Carcinoma, Renal Cell
Kidney Neoplasms
Kidney Diseases
Biological: AGS-16M18
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Incidence of adverse events [ Time Frame: Throughout the treatment ] [ Designated as safety issue: No ]
  • Assessment of PK variables [ Time Frame: Weeks 0 - 5, week 8, weekly during extension period, 2 and 3 months after last dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Changes in tumor status [ Time Frame: Week 5, week 8, every 8 weeks during extension period ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: October 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00816686

Locations
United States, Maryland
Baltimore, Maryland, United States, 21231
United States, New York
New York, New York, United States, 10021
Sponsors and Collaborators
Astellas Pharma Inc
Agensys, Inc.
Investigators
Study Director: Use Central Contact Agensys, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00816686     History of Changes
Other Study ID Numbers: 2007002
Study First Received: January 1, 2009
Last Updated: February 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
clinical trial, phase 1
carcinoma, advanced renal cell
kidney
pharmacokinetics
safety
AGS-16M18

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

ClinicalTrials.gov processed this record on August 01, 2014