A First in Man Study to Determine the Safety at Various Dose Levels of AGS-16M8F in Advanced Kidney Cancer

Renal Cell Carcinoma Clinical Trial

Official title:

A Phase 1, Open-label, Multi-center, Dose Escalation Study of the Safety and Pharmacokinetics of AGS-16M8F Monotherapy in Subjects With Advanced Renal Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01114230
• Other study ID #: 2009002
• Status: Completed
• Phase: Phase 1
• First received: April 29, 2010
• Last updated: December 10, 2012
• Start date: August 2010
• Est. completion date: November 2012

Study information

• Verified date: December 2012
• 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

The purpose of this dose escalation study is to examine the safety and pharmacokinetics (PK) of AGS-16M8F administered in subjects with advanced renal cell carcinoma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• 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 amenable to cure by surgery or other means.

• Non-measurable or measurable disease according to Response Criteria for Solid Tumors (RECIST Version 1.1)

• Eastern Cooperative Group (ECOG) performance status of 0-1

• Negative pregnancy test (women of childbearing potential)

• Hematologic function, as follows:

• Absolute neutrophil count (ANC) = 1.5 x 109/L

• Platelet count = 100 x 109/L

• Hemoglobin = 9 g/dL (transfusions are allowed)

• Renal function, as follows:

• creatinine = 1.5 x upper limit of normal (ULN), or calculated glomerular filtration rate (GFR) > 50 mL/min if creatinine > 1.5x ULN

• Hepatic function, as follows:

• Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) = 2.5 x ULN or = 5x ULN if known liver metastases

• Total bilirubin = 1.5 x ULN

• International Normalized Ratio (INR) < 1.3 (or = 3.0 if on therapeutic anticoagulation)

• Women and men of childbearing potential must be advised and agree to practice effective methods of contraception during the course of the study and for four weeks after the last AGS-16M8F infusion administration

Exclusion Criteria:

• Past or present documented central nervous system (CNS) tumor or CNS metastasis

• Use of any investigational drug (including marketed drugs not approved for this indication) within 4 weeks prior to screening

• History of thromboembolic events and bleeding disorders = 3 months (e.g., DVT or PE)

• Active angina or Class III or IV Congestive Heart Failure (New York Heart Association CHF Functional Classification System) or clinically significant cardiac disease within 12 months of study enrollment, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, congestive heart failure, uncontrolled hypertension, or arrythmias not controlled by outpatient medication

• Major surgery (that requires general anesthesia) within 4 weeks of study enrollment

• Women who are pregnant (confirmed by positive pregnancy test) or lactating

• Known positive test for human immunodeficiency virus (HIV), hepatitis C, or hepatitis B surface antigen

• Active infection requiring treatment with systemic (intravenous or oral) anti-infectives (antibiotic, antifungal, or antiviral agent) within 72 hours of screening

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
• Pharmacokinetics of AGS-16M8F
• Renal Cell Carcinoma

Intervention

Drug:
• AGS-16M8F
IV

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Seattle Cancer Care Alliance	Seattle	Washington

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	Safety assessed by recording adverse events, vital signs and laboratory assessments		For 12 weeks during treatment period and up to 4 weeks follow up	No
Primary	Pharmacokinetic variables assessment through analysis of blood samples		Up to day 15 for cycle 1 and cycle 4 and pre-dose for cycles 2 and 3; every 3 weeks during the second 12 weeks of treatment; and if subject continues on study drug, every 12 weeks thereafter	No
Secondary	Incidence of anti-AGS-16M8F antibody formation		Baseline; up to day 64 during the first 12 weeks; and if subject continues on study drug, every 3 weeks during the second 12 weeks of treatment and every 12 weeks thereafter	No
Secondary	Incidence of Tumor Response (complete or partial response)		Baseline and every 12 weeks while on study drug	No