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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Carcinoma, Renal Cell Kidney Neoplasms Kidney Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1. AGS-16M18 Dose 1

Group Type EXPERIMENTAL

AGS-16M18

Intervention Type BIOLOGICAL

IV Infusion

2. AGS-16M18 Dose 2

Group Type EXPERIMENTAL

AGS-16M18

Intervention Type BIOLOGICAL

IV Infusion

3. AGS-16M18 Dose 3

Group Type EXPERIMENTAL

AGS-16M18

Intervention Type BIOLOGICAL

IV Infusion

4. AGS-16M18 Dose 4

Group Type EXPERIMENTAL

AGS-16M18

Intervention Type BIOLOGICAL

IV Infusion

5. AGS-16M18 Dose 5

Group Type EXPERIMENTAL

AGS-16M18

Intervention Type BIOLOGICAL

IV Infusion

Interventions

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AGS-16M18

IV Infusion

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No