search
Back to results

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

Primary Purpose

Carcinoma, Renal Cell, Kidney Neoplasms, Kidney Diseases

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AGS-16M18
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Renal Cell focused on measuring clinical trial, phase 1, carcinoma, advanced renal cell, kidney, pharmacokinetics, safety, AGS-16M18

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

1. AGS-16M18 Dose 1

2. AGS-16M18 Dose 2

3. AGS-16M18 Dose 3

4. AGS-16M18 Dose 4

5. AGS-16M18 Dose 5

Arm Description

Outcomes

Primary Outcome Measures

Incidence of adverse events
Assessment of PK variables

Secondary Outcome Measures

Incidence of anti-AGS-16M18 antibody formation
Changes in tumor status

Full Information

First Posted
January 1, 2009
Last Updated
February 26, 2013
Sponsor
Astellas Pharma Inc
Collaborators
Agensys, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00816686
Brief Title
A Phase 1 Study of the Safety and Pharmacokinetics of AGS-16M18 in Subjects With Advanced Renal Cell Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Terminated
Why Stopped
Trial was terminated due to the need to re-formulate the study drug.
Study Start Date
October 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
Collaborators
Agensys, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Renal Cell, Kidney Neoplasms, Kidney Diseases
Keywords
clinical trial, phase 1, carcinoma, advanced renal cell, kidney, pharmacokinetics, safety, AGS-16M18

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1. AGS-16M18 Dose 1
Arm Type
Experimental
Arm Title
2. AGS-16M18 Dose 2
Arm Type
Experimental
Arm Title
3. AGS-16M18 Dose 3
Arm Type
Experimental
Arm Title
4. AGS-16M18 Dose 4
Arm Type
Experimental
Arm Title
5. AGS-16M18 Dose 5
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
AGS-16M18
Intervention Description
IV Infusion
Primary Outcome Measure Information:
Title
Incidence of adverse events
Time Frame
Throughout the treatment
Title
Assessment of PK variables
Time Frame
Weeks 0 - 5, week 8, weekly during extension period, 2 and 3 months after last dose
Secondary Outcome Measure Information:
Title
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
Title
Changes in tumor status
Time Frame
Week 5, week 8, every 8 weeks during extension period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Agensys, Inc.
Official's Role
Study Director
Facility Information:
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.clinicaltrials.jp/user/ctrDetail_e.jsp?resultId=535
Description
Link to results on JAPIC

Learn more about this trial

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

We'll reach out to this number within 24 hrs