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

NCT01114230 | Completed Phase 1

• 1 other identifier: 2009002
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Renal Cell Carcinoma; Pharmacokinetics of AGS-16M8F

Keywords

Advanced Renal Cell Carcinoma; Advanced Kidney Cancer; AGS-16M8F

Outcome Measures

Primary Outcomes (2)

• Safety assessed by recording adverse events, vital signs and laboratory assessments

  For 12 weeks during treatment period and up to 4 weeks follow up

• 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

Secondary Outcomes (2)

• 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

• Incidence of Tumor Response (complete or partial response)

  Baseline and every 12 weeks while on study drug

Study Arms (9)

Dose Level 1

EXPERIMENTAL

Drug: AGS-16M8F

Dose Level 2

EXPERIMENTAL

Drug: AGS-16M8F

Dose Level 3

EXPERIMENTAL

Drug: AGS-16M8F

Dose Level 4

EXPERIMENTAL

Drug: AGS-16M8F

Dose Level 5

EXPERIMENTAL

Drug: AGS-16M8F

Dose Level 6

EXPERIMENTAL

Drug: AGS-16M8F

Dose Level 7

EXPERIMENTAL

Drug: AGS-16M8F

Dose Level 8

EXPERIMENTAL

Drug: AGS-16M8F

Dose Level 9

EXPERIMENTAL

Drug: AGS-16M8F

Interventions

AGS-16M8F DRUG

IV

Dose Level 1; Dose Level 2; Dose Level 3; Dose Level 4; Dose Level 5; Dose Level 6; Dose Level 7; Dose Level 8; Dose Level 9

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (3)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

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

Study Officials

• Chief Medical Officer

  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: April 29, 2010
• First Posted: May 3, 2010
• Study Start: August 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: December 12, 2012

Record last verified: 2012-12

Locations

US (3)