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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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Agensys, Inc. )
ClinicalTrials.gov Identifier:
NCT01672775
First received: August 22, 2012
Last updated: September 30, 2014
Last verified: September 2014

August 22, 2012
September 30, 2014
July 2012
December 2014   (final data collection date for primary outcome measure)
Incidence of Adverse Events [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01672775 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    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)
  • Incidence of antidrug antibody formation to human native antibody (AGS-16C) and antibody drug conjugate (AGS-16C3F) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Tumor response: objective response rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Determined from the subjects' best response and will include complete response (CR) and partial response (PR)
  • Tumor response: disease control rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Determined from the subjects' best response will include complete response (CR) partial response (PR), and stable disease (SD)
  • Tumor response: Changes in bone scans [ Time Frame: Baseline, Week 13 and every 12 weeks thereafter ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
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 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).

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Carcinoma, Renal Cell
  • Renal Cell Carcinoma With Clear Cell Histology
  • Renal Cell Carcinoma With Non-Clear Cell Histology
  • Renal Cell Carcinoma of Papillary Histology
Drug: AGS-16C3F
intravenous (IV) infusion
  • Experimental: Cohort 1 AGS-16C3F highest dose
    Renal Cell Carcinoma subjects with clear and non-clear histology
    Intervention: Drug: AGS-16C3F
  • Experimental: Cohort 0 AGS-16C3F higher dose
    Renal Cell Carcinoma subjects with clear and non-clear histology
    Intervention: Drug: AGS-16C3F
  • Experimental: Cohort (-1) AGS-16C3F high dose
    Renal Cell Carcinoma subjects with clear and non-clear histology
    Intervention: Drug: AGS-16C3F
  • Experimental: Cohort (-2) AGS-16C3F middle dose
    Renal Cell Carcinoma subjects with clear and non-clear histology
    Intervention: Drug: AGS-16C3F
  • Experimental: Cohort (-3) AGS-16C3F low dose
    Renal Cell Carcinoma subjects with clear and non-clear histology
    Intervention: Drug: AGS-16C3F
  • Experimental: Cohort (-4) AGS-16C3F lowest dose
    Renal Cell Carcinoma subjects with clear and non-clear histology
    Intervention: Drug: AGS-16C3F
  • Experimental: AGS-16C3F in RCC Subjects with Clear Cell Histology
    Expansion Cohort
    Intervention: Drug: AGS-16C3F
  • Experimental: AGS-16C3F in RCC Subjects with Papillary Histology
    Expansion Cohort
    Intervention: Drug: AGS-16C3F
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
34
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01672775
AGS-16C3F-12-2
No
Astellas Pharma Inc ( Agensys, Inc. )
Agensys, Inc.
Not Provided
Study Director: Medical Director Agensys, Inc.
Astellas Pharma Inc
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP