Know Cancer

or
forgot password

A Phase 1, Open Label, Multi-center Study to Assess the Safety, Pharmacokinetics and Effectiveness of AGS-16C3F Monotherapy in Subjects With Renal Cell Carcinoma (RCC) of Clear Cell or Papillary Histology


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Renal Cell, Renal Cell Carcinoma With Clear Cell Histology, Renal Cell Carcinoma With Non-Clear Cell Histology, Renal Cell Carcinoma of Papillary Histology

Thank you

Trial Information

A Phase 1, Open Label, Multi-center Study to Assess the Safety, Pharmacokinetics and Effectiveness of AGS-16C3F Monotherapy in Subjects With Renal Cell Carcinoma (RCC) of Clear Cell or Papillary Histology


The study has two components. The first aims to establish a safe dose for AGS-16C3F. Once
identified, the safety and effectiveness will be tested in additional subjects with either
clear cell or papillary histology in expanded cohorts.


Inclusion Criteria:



- Dose determination cohorts: Histologically confirmed diagnosis of metastatic RCC of
either clear cell or non-clear histology.

- Tumors with clear cell histology: subject must have progressed after at least
one anti-vascular endothelial growth factor receptor (anti-VEGFR) therapy

- Tumors with non-clear cell histology must be ectonucleotide
pyrophosphatase/phosphodiesterase family member 3 (ENPP3) positive at
pre-screening. This sub-group does not have any prior therapy requirement.

- Dose expansion cohorts: Histologically confirmed diagnosis of metastatic RCC of
either clear cell or papillary histology

- Tumors with clear cell histology: subject must have progressed after at least
one anti-VEGFR therapy

- Tumors with papillary histology: includes unclassified histology with papillary
features and must be ENPP3 positive at pre-screening. This sub-group does not
have any prior therapy requirement.

- Measurable disease according to Response Criteria for Solid Tumors (RECIST Version
1.1)

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

- 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 4 weeks
after the last AGS-16C3F infusion administration

Exclusion Criteria:

- Current uncontrolled central nervous system (CNS) metastasis or malignant brain
tumors

- Use of any investigational drug (including marketed drugs not approved for this
indication) within 4 weeks prior to screening. No time limit applies to the use of
marketed drugs approved for this indication provided that the subject has progressed
on the treatment and all toxicities attributable to the drug have resolved or
returned to baseline

- Known sensitivity to any of the ingredients of the investigational product AGS-16C3F

- History of thromboembolic events and bleeding disorders ≤3 months (e.g., (deep vein
thrombosis) DVT or pulmonary embolism (PE))

- Active angina or Class III or IV Congestive Heart Failure (CHF) (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 arrhythmias not controlled by outpatient
medication.

- Major surgery 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.

- History of eye surgery within 6 months, presence of cataracts or other ocular
disorders significantly affecting vision

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of Adverse Events

Outcome Time Frame:

24 months

Safety Issue:

Yes

Principal Investigator

Medical Director

Investigator Role:

Study Director

Investigator Affiliation:

Agensys, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

AGS-16C3F-12-2

NCT ID:

NCT01672775

Start Date:

July 2012

Completion Date:

October 2013

Related Keywords:

  • Carcinoma, Renal Cell
  • Renal Cell Carcinoma With Clear Cell Histology
  • Renal Cell Carcinoma With Non-Clear Cell Histology
  • Renal Cell Carcinoma of Papillary Histology
  • Renal Cell Carcinoma
  • Pharmacokinetics of AGS-16C3F
  • AGS-16C3F
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Seattle Cancer Care AllianceSeattle, Washington  98109
University of Michigan Medical CenterAnn Arbor, Michigan  48104-0914
Karmanos Cancer InstituteDetroit, Michigan  48201