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

NCT00816686 | Terminated Phase 1

• 1 other identifier: 2007002
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

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.

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms; Kidney Diseases

Keywords

clinical trial, phase 1; carcinoma, advanced renal cell; kidney; pharmacokinetics; safety; AGS-16M18

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (5)

1. AGS-16M18 Dose 1

EXPERIMENTAL

Biological: AGS-16M18

2. AGS-16M18 Dose 2

EXPERIMENTAL

Biological: AGS-16M18

3. AGS-16M18 Dose 3

EXPERIMENTAL

Biological: AGS-16M18

4. AGS-16M18 Dose 4

EXPERIMENTAL

Biological: AGS-16M18

5. AGS-16M18 Dose 5

EXPERIMENTAL

Biological: AGS-16M18

Interventions

AGS-16M18 BIOLOGICAL

IV Infusion

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead
• Agensys, Inc.: collaborator

Study Sites (2)

Unknown Facility

Baltimore, Maryland, 21231, United States

Location

Unknown Facility

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms; Kidney Diseases; Carcinoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Use Central Contact

  Agensys, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2009
• First Posted: January 5, 2009
• Study Start: October 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: February 27, 2013

Record last verified: 2010-05

Locations

US (2)