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

Kidney Diseases Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00816686
• Other study ID #: 2007002
• Status: Terminated
• Phase: Phase 1
• First received: January 1, 2009
• Last updated: February 26, 2013
• Start date: October 2008
• Est. completion date: April 2010

Study information

• Verified date: May 2010
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Kidney Diseases
• Kidney Neoplasms

Intervention

Biological:
• AGS-16M18
IV Infusion

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Agensys, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		Throughout the treatment	No
Primary	Assessment of PK variables		Weeks 0 - 5, week 8, weekly during extension period, 2 and 3 months after last dose	No
Secondary	Incidence of anti-AGS-16M18 antibody formation		Week 0, week 1, week 4, week 8, every 8 weeks during extension period, 2 and 3 months after last dose	No
Secondary	Changes in tumor status		Week 5, week 8, every 8 weeks during extension period	No

External Links

•   Link to results on JAPIC