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

January 1, 2009
February 26, 2013
October 2008
April 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00816686 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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, evdry 8 weeks during extension period ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Phase 1 Study of the Safety and Pharmacokinetics of AGS-16M18 in Subjects With Advanced Renal Cell Cancer
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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Kidney Diseases
Biological: AGS-16M18
IV Infusion
  • Experimental: 1. AGS-16M18 Dose 1
    Intervention: Biological: AGS-16M18
  • Experimental: 2. AGS-16M18 Dose 2
    Intervention: Biological: AGS-16M18
  • Experimental: 3. AGS-16M18 Dose 3
    Intervention: Biological: AGS-16M18
  • Experimental: 4. AGS-16M18 Dose 4
    Intervention: Biological: AGS-16M18
  • Experimental: 5. AGS-16M18 Dose 5
    Intervention: Biological: AGS-16M18
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
7
April 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00816686
2007002
No
Astellas Pharma Inc
Astellas Pharma Inc
Agensys, Inc.
Study Director: Use Central Contact Agensys, Inc.
Astellas Pharma Inc
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP