We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A 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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01672775
Recruitment Status : Completed
First Posted : August 27, 2012
Last Update Posted : December 19, 2020
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Agensys, Inc. )

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to evaluate the safety and pharmacokinetics and assess the immunogenicity and effectiveness of AGS-16C3F in subjects with renal cell cancer (RCC).

Condition or disease Intervention/treatment Phase
Carcinoma, Renal Cell Renal Cell Carcinoma of Papillary Histology Renal Cell Carcinoma With Clear Cell Histology Renal Cell Carcinoma With Non-Clear Cell Histology Drug: AGS-16C3F Phase 1

Detailed Description:
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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 18, 2012
Actual Primary Completion Date : February 21, 2017
Actual Study Completion Date : February 21, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Cohort 1 AGS-16C3F highest dose
Renal Cell Carcinoma subjects with clear and non-clear histology
 Drug: AGS-16C3F
intravenous (IV) infusion
Experimental: Cohort 0 AGS-16C3F higher dose
Renal Cell Carcinoma subjects with clear and non-clear histology
 Drug: AGS-16C3F
intravenous (IV) infusion
Experimental: Cohort (-1) AGS-16C3F high dose
Renal Cell Carcinoma subjects with clear and non-clear histology
 Drug: AGS-16C3F
intravenous (IV) infusion
Experimental: Cohort (-2) AGS-16C3F middle dose
Renal Cell Carcinoma subjects with clear and non-clear histology
 Drug: AGS-16C3F
intravenous (IV) infusion
Experimental: Cohort (-3) AGS-16C3F low dose
Renal Cell Carcinoma subjects with clear and non-clear histology
 Drug: AGS-16C3F
intravenous (IV) infusion
Experimental: Cohort (-4) AGS-16C3F lowest dose
Renal Cell Carcinoma subjects with clear and non-clear histology
 Drug: AGS-16C3F
intravenous (IV) infusion
Experimental: AGS-16C3F in RCC Subjects with Clear Cell Histology
Expansion Cohort
 Drug: AGS-16C3F
intravenous (IV) infusion
Experimental: AGS-16C3F in RCC Subjects with Papillary Histology
Expansion Cohort
 Drug: AGS-16C3F
intravenous (IV) infusion


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Incidence of Adverse Events [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Pharmacokinetic profile for total antibody (TAb), antibody drug conjugate (ADC), and monomethyl auristatin F (MMAF): Ceoi or Cmax, Ctrough, Tmax, AUCτ, t1/2, CL, and Vss [ Time Frame: Days 1, 2, 3, 4, 8, 15, 22, 43, 64, 65, 66, 67, 71, 78, and 92 ]
    Concentration at end of infusion (Ceoi) or maximum observed concentrations (Cmax), Trough concentration (Ctrough), time to maximum concentration (Tmax), partial area under the serum concentration-time curve (AUCτ), terminal or apparent half-life (t1/2), systemic clearance (CL), and volume of distribution at steady state (Vss)

  2. Incidence of antidrug antibody formation to human native antibody (AGS-16C) and antibody drug conjugate (AGS-16C3F) [ Time Frame: 24 months ]
  3. Tumor response: objective response rate [ Time Frame: 24 months ]
    Determined from the subjects' best response and will include complete response (CR) and partial response (PR)

  4. Tumor response: disease control rate [ Time Frame: 24 months ]
    Determined from the subjects' best response will include complete response (CR) partial response (PR), and stable disease (SD)

  5. Tumor response: Changes in bone scans [ Time Frame: Baseline, Week 13 and every 12 weeks thereafter ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01672775


Locations
Layout table for location information
United States, Michigan
Site US00005 University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
Site US00003 Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, New York
Site US00004 Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Site US00002 Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
United States, Washington
Site US00001 Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Canada, Alberta
Site CA00006 Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Site CA00008 British Columbia Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Site CA00009 London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Canada, Quebec
Site CA00007 Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Agensys, Inc.
Investigators
Layout table for investigator information
Study Director: Medical Director Agensys, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Agensys, Inc.
ClinicalTrials.gov Identifier: NCT01672775    
Other Study ID Numbers: AGS-16C3F-12-2
First Posted: August 27, 2012    Key Record Dates
Last Update Posted: December 19, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Keywords provided by Astellas Pharma Inc ( Agensys, Inc. ):
Renal Cell Carcinoma
AGS-16C3F
Pharmacokinetics of AGS-16C3F
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
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