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

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Terminated

CT.gov ID

NCT00816686

Collaborator

Agensys, Inc. (Industry)

Enrollment

Locations

Arms

Duration (Months)

3.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

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

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

7 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Oct 1, 2008

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Incidence of adverse events [Throughout the treatment]
Assessment of PK variables [Weeks 0 - 5, week 8, weekly during extension period, 2 and 3 months after last dose]

Secondary Outcome Measures

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]
Changes in tumor status [Week 5, week 8, every 8 weeks during extension period]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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