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

Phase 1TerminatedNCT00816686

Astellas Pharma Inc7 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoma, Renal Cell Kidney Neoplasms Kidney Diseases

Interventions

AGS-16M18BIOLOGICAL

IV Infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Unnamed facility

Baltimore, Maryland, United States

Unnamed facility

New York, New York, United States

Outcomes

Primary Outcomes

Incidence of adverse events

Time frame: Throughout the treatment

Assessment of PK variables

Time frame: Weeks 0 - 5, week 8, weekly during extension period, 2 and 3 months after last dose

Secondary Outcomes

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

Changes in tumor status

Time frame: Week 5, week 8, every 8 weeks during extension period

Data from ClinicalTrials.gov

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