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:
Astellas Pharma Inc
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 May 21, 2013