LUX-Head&Neck 1: A Phase III Trial of Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic (R/M) Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01345682
First received: April 28, 2011
Last updated: May 16, 2016
Last verified: May 2016
  Purpose
This randomised, open-label, phase III study will be performed in patients with R/M head and neck squamous cell carcinoma (HNSCC) who have progressed after platinum-based therapy. The objectives of the trial are to compare the efficacy and safety of afatinib versus methotrexate

Condition Intervention Phase
Head and Neck Neoplasms
Carcinoma, Squamous Cell
Drug: Afatinib
Drug: Methotrexate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised, Open-label, Phase III Study to Evaluate the Efficacy and Safety of Oral Afatinib (BIBW 2992) Versus Intravenous Methotrexate in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma Who Have Progressed After Platinum-based Therapy

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Progression-free Survival (PFS) Based on Central Independent Review [ Time Frame: From randomization until disease progression, death or data cut-off (07May2014); Up to 28 months ] [ Designated as safety issue: No ]

    PFS was defined as the time from the date of randomisation to disease progression or death, whichever occurred first. The primary analysis of PFS considered PFS events as assessed by central independent review, including all data collected until the cut-off date (7 May 2014).

    The date of disease progression was recorded based on RECIST version 1.1. Unequivocal progression of disease was determined if at least one of the following criteria applied:

    • At least 20% increase in the SoD of target lesions taking as reference the smallest SoD recorded since the treatment started, together with an absolute increase in the SoD of at least 5 mm
    • Appearance of one or more new lesions
    • Unequivocal progression of existing non-target lesions


Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: From randomization until death or data cut-off (30Jun2014); Up to 29 months ] [ Designated as safety issue: No ]
    Overall survival (OS) was a key secondary endpoint of this trial. OS was defined as the time from randomisation to death (irrespective of the cause of death). Patients for whom there was no evidence of death at the cut-off date (30 Jun 2014) were to be censored on the date that they were last known to be alive.

  • Objective Response (OR) [ Time Frame: Tumour imaging was to be performed every 6 weeks during the first 24 weeks of treatment, and hereafter every 8 weeks (Up to 28 months) ] [ Designated as safety issue: No ]

    OR is defined as the best overall response of complete response (CR) and partial response (PR) according to RECIST version 1.1, CR for target lesions (TL): Disappearance of all target lesions. CR for non-target lesions (NTL): Disappearance of all non-target lesions. All lymph nodes must be non-pathological in size (<10mm short axis).

    PR for TL: At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.

    Other factors which add to the overall response of an imaging timepoint as PR are as below:-

    • CR in TL, but non-CR/Non-PD in NTL leads to PR
    • CR in TL, but not evaluated NTL leads to PR
    • PR in TL, but non-PD NTL or not all evaluated NTL leads to PR;

    All the above scenarios should also satisfy 'No occurrence of new lesions'.


  • Disease Control (DC) [ Time Frame: Tumour imaging was to be performed every 6 weeks during the first 24 weeks of treatment, and hereafter every 8 weeks (Up to 28 months) ] [ Designated as safety issue: No ]

    DC is defined as the best overall response of CR, PR, stable disease (SD) and non-CR/non-PD.

    CR for target lesions (TL): Disappearance of all target lesions. CR for non-target lesions (NTL): Disappearance of all non-target lesions . All lymph nodes must be non-pathological in size (<10mm short axis).

    PR for TL: At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.

    Other factors which add to the overall response of an imaging timepoint as PR are as below:-

    • CR in TL, but non-CR/Non-PD in NTL leads to PR
    • CR in TL, but not evaluated NTL leads to PR
    • PR in TL, but non-PD NTL or not all evaluated NTL leads to PR;

    SD for TL: change in the sum of diameters does not satisfy PR or PD.

    SD in TL, non-PD in NTL lead to overall response of SD, provided there is no appearance of new lesions.


  • Tumour Shrinkage [ Time Frame: Tumour imaging was to be performed every 6 weeks during the first 24 weeks of treatment, and hereafter every 8 weeks (Up to 28 months) ] [ Designated as safety issue: No ]

    Tumour shrinkage, defined as the maximum decrease from baseline in the sum of diameters of the target lesions, as measured by central imaging. The longest diameter of target lesions was recorded, except for lymph nodes, which were measured by their short axis.

    Negative values indicate a reduction in the sum of target lesion diameters and positive values an increase.

    Percentage of Participants with Tumour shrinkage as per the categories (>=20% increase, >=0 − <20% increase, >0 − <30% decrease, >=30 − <50% decrease, >=50% decrease) are presented.


  • Health Related Quality of Life (HRQOL)- Change in Pain Scores Over Time [ Time Frame: From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months. ] [ Designated as safety issue: No ]

    The HRQOL analyses focused on pain, swallowing, and global health status measured by the European Organisation for Research and Treatment of Cancer [EORTC] quality of life questionnaires Core 30 [QLQ-C30], and head and neck cancer specific supplementary module EORTC QLQ-H&N35:

    Pain scale from H&N35, Swallowing scale from H&N35 and Global health status/QoL scale from C30.

    Pain scale includes items 31-34 from H&N 35; Swallowing scale includes items 35-38 from H&N35 and Global health status/QoL scale includes items 29-30 from C30.

    The scores of these scales were averaged from the scores of the component items, transformed and analyzed on 0 - 100 scale. For pain and swallowing scales, higher scores represent worse outcome; for the global health/QoL scale, higher scores represent better outcome.

    Changes in scores over time were assessed using longitudinal models.

    The analyses of HRQOL are presented for the 07 May 2014 cut-off date.


  • Health Related Quality of Life (HRQOL)- Change in Swallowing Scores Over Time [ Time Frame: From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months. ] [ Designated as safety issue: No ]

    The HRQOL analyses focused on pain, swallowing, and global health status measured by the European Organisation for Research and Treatment of Cancer [EORTC] quality of life questionnaires Core 30 [QLQ-C30], and head and neck cancer specific supplementary module EORTC QLQ-H&N35:

    Pain scale from H&N35, Swallowing scale from H&N35 and Global health status/QoL scale from C30.

    Pain scale includes items 31-34 from H&N 35; Swallowing scale includes items 35-38 from H&N35 and Global health status/QoL scale includes items 29-30 from C30.

    The scores of these scales were averaged from the scores of the component items, transformed and analyzed on 0 - 100 scale. For pain and swallowing scales, higher scores represent worse outcome; for the global health/QoL scale, higher scores represent better outcome.

    Changes in scores over time were assessed using longitudinal models.

    The analyses of HRQOL are presented for the 07 May 2014 cut-off date.


  • Health Related Quality of Life (HRQOL)- Change in Global Health Scores Over Time [ Time Frame: From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months. ] [ Designated as safety issue: No ]

    The HRQOL analyses focused on pain, swallowing, and global health status measured by the European Organisation for Research and Treatment of Cancer [EORTC] quality of life questionnaires Core 30 [QLQ-C30], and head and neck cancer specific supplementary module EORTC QLQ-H&N35:

    Pain scale from H&N35, Swallowing scale from H&N35 and Global health status/QoL scale from C30.

    Pain scale includes items 31-34 from H&N 35; Swallowing scale includes items 35-38 from H&N35 and Global health status/QoL scale includes items 29-30 from C30.

    The scores of these scales were averaged from the scores of the component items, transformed and analyzed on 0 - 100 scale. For pain and swallowing scales, higher scores represent worse outcome; for the global health/QoL scale, higher scores represent better outcome.

    Changes in scores over time were assessed using longitudinal models.

    The analyses of HRQOL are presented for the 07 May 2014 cut-off date.


  • Status Change in Pain Scale [ Time Frame: From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months. ] [ Designated as safety issue: No ]
    Distribution of patients with improved, stable or worsened HRQOL: Improvement was defined as a score improved by at least 10 points from baseline (on the 0-100 point scale) at any time during the trial. If a patient had not improved, worsening was defined as a 10-point worsening at any time during the trial. Otherwise, a patient was considered as stable.

  • Status Change in Swallowing Scale [ Time Frame: From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months. ] [ Designated as safety issue: No ]
    Distribution of patients with improved, stable or worsened HRQOL: Improvement was defined as a score improved by at least 10 points from baseline (on the 0-100 point scale) at any time during the trial. If a patient had not improved, worsening was defined as a 10-point worsening at any time during the trial. Otherwise, a patient was considered as stable.

  • Status Change in Global Health Status Scale [ Time Frame: From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months. ] [ Designated as safety issue: No ]
    Distribution of patients with improved, stable or worsened HRQOL: Improvement was defined as a score improved by at least 10 points from baseline (on the 0-100 point scale) at any time during the trial. If a patient had not improved, worsening was defined as a 10-point worsening at any time during the trial. Otherwise, a patient was considered as stable.

  • Time to Deterioration in Pain [ Time Frame: From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months. ] [ Designated as safety issue: No ]
    The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death.

  • Time to Deterioration in Swallowing [ Time Frame: From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months. ] [ Designated as safety issue: No ]
    The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death.

  • Time to Deterioration in Global Health Status [ Time Frame: From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months. ] [ Designated as safety issue: No ]
    The time to deterioration was defined as the time from randomisation to a score decreased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death.


Enrollment: 483
Study Start Date: January 2012
Estimated Study Completion Date: July 2016
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Afatinib (BIBW 2992)
Once daily
Drug: Afatinib
Once daily
Active Comparator: Methotrexate
Weekly
Drug: Methotrexate
Weekly

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Histologically or cytologically confirmed R/M HNSCC of the oral cavity, oropharynx, hypopharynx or larynx, not amenable for salvage surgery or radiotherapy
  2. Documented progressive disease based on investigator assessment according to Response Evaluation Criteria in Solid Tumours (RECIST) following receipt of at least two cycles of cisplatin or carboplatin administered for R/M disease
  3. Measurable disease according to RECIST
  4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion criteria:

  1. Progressive disease within three months of completion of curatively intended treatment for locoregionally advanced or metastatic HNSCC
  2. Any other than one previous platinum based systemic regimen given for R/M disease
  3. Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules
  4. Pregnancy or breast feeding
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01345682

  Hide Study Locations
Locations
United States, Illinois
1200.43.00113 Boehringer Ingelheim Investigational Site
Harvey, Illinois, United States
1200.43.00106 Boehringer Ingelheim Investigational Site
Peoria, Illinois, United States
United States, Massachusetts
1200.43.00110 Boehringer Ingelheim Investigational Site
Boston, Massachusetts, United States
United States, Nebraska
1200.43.00107 Boehringer Ingelheim Investigational Site
Omaha, Nebraska, United States
United States, New York
1200.43.00105 Boehringer Ingelheim Investigational Site
Stony Brook, New York, United States
United States, Pennsylvania
1200.43.00102 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
1200.43.00103 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
United States, Texas
1200.43.00109 Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
Argentina
1200.43.05401 Boehringer Ingelheim Investigational Site
Ciudad Autonoma de Buenos Aires, Argentina
1200.43.05403 Boehringer Ingelheim Investigational Site
Villa Dominico, Argentina
Austria
1200.43.04303 Boehringer Ingelheim Investigational Site
Leoben, Austria
1200.43.04305 Boehringer Ingelheim Investigational Site
Salzburg, Austria
1200.43.04301 Boehringer Ingelheim Investigational Site
Wien, Austria
Belgium
1200.43.03202 Boehringer Ingelheim Investigational Site
Bruxelles, Belgium
1200.43.03203 Boehringer Ingelheim Investigational Site
Edegem, Belgium
1200.43.03204 Boehringer Ingelheim Investigational Site
Gent, Belgium
1200.43.03201 Boehringer Ingelheim Investigational Site
Leuven, Belgium
Brazil
1200.43.05504 Boehringer Ingelheim Investigational Site
Barretos, Brazil
1200.43.05505 Boehringer Ingelheim Investigational Site
Jau, Brazil
1200.43.05507 Boehringer Ingelheim Investigational Site
Passo Fundo, Brazil
1200.43.05503 Boehringer Ingelheim Investigational Site
Porto Alegre, Brazil
1200.43.05502 Boehringer Ingelheim Investigational Site
Rio de Janeiro, Brazil
1200.43.05501 Boehringer Ingelheim Investigational Site
Sao Paulo, Brazil
1200.43.05506 Boehringer Ingelheim Investigational Site
Sao Paulo, Brazil
Czech Republic
1200.43.04202 Boehringer Ingelheim Investigational Site
Olomouc, Czech Republic
1200.43.04203 Boehringer Ingelheim Investigational Site
Prague 2, Czech Republic
1200.43.04201 Boehringer Ingelheim Investigational Site
Prague 8, Czech Republic
Denmark
1200.43.04501 Boehringer Ingelheim Investigational Site
København Ø, Denmark
France
1200.43.03304 Boehringer Ingelheim Investigational Site
Avignon Cedex 9, France
1200.43.03312 Boehringer Ingelheim Investigational Site
Dijon Cedex, France
1200.43.03303 Boehringer Ingelheim Investigational Site
Lille Cedex, France
1200.43.03301 Boehringer Ingelheim Investigational Site
Lyon Cedex, France
1200.43.03302 Boehringer Ingelheim Investigational Site
Montpellier cedex 5, France
1200.43.03307 Boehringer Ingelheim Investigational Site
Nice cedex 2, France
1200.43.03314 Boehringer Ingelheim Investigational Site
Paris Cedex 05, France
1200.43.03305 Boehringer Ingelheim Investigational Site
Poitiers, France
1200.43.03316 Boehringer Ingelheim Investigational Site
Rouen Cedex 1, France
1200.43.03309 Boehringer Ingelheim Investigational Site
Saint Herblain Cedex, France
1200.43.03310 Boehringer Ingelheim Investigational Site
Vandoeuvre les Nancy cedex, France
1200.43.03317 Boehringer Ingelheim Investigational Site
Villejuif Cedex, France
Germany
1200.43.04903 Boehringer Ingelheim Investigational Site
Aachen, Germany
1200.43.04902 Boehringer Ingelheim Investigational Site
Berlin, Germany
1200.43.04909 Boehringer Ingelheim Investigational Site
Dresden, Germany
1200.43.04901 Boehringer Ingelheim Investigational Site
Essen, Germany
1200.43.04905 Boehringer Ingelheim Investigational Site
Hamburg, Germany
1200.43.04906 Boehringer Ingelheim Investigational Site
Hannover, Germany
1200.43.04908 Boehringer Ingelheim Investigational Site
Jena, Germany
1200.43.04904 Boehringer Ingelheim Investigational Site
Leipzig, Germany
1200.43.04907 Boehringer Ingelheim Investigational Site
Mannheim, Germany
Greece
1200.43.03004 Boehringer Ingelheim Investigational Site
Haidari, Greece
1200.43.03005 Boehringer Ingelheim Investigational Site
Heraklion, Greece
1200.43.03002 Boehringer Ingelheim Investigational Site
Thessaloniki, Greece
Israel
1200.43.97201 Boehringer Ingelheim Investigational Site
Haifa, Israel
1200.43.97203 Boehringer Ingelheim Investigational Site
Petach Tikva, Israel
1200.43.97204 Boehringer Ingelheim Investigational Site
Tel Hashomer, Israel
Italy
1200.43.03909 Boehringer Ingelheim Investigational Site
Aosta, Italy
1200.43.03908 Boehringer Ingelheim Investigational Site
Cagliari, Italy
1200.43.03901 Boehringer Ingelheim Investigational Site
Confreria (cn), Italy
1200.43.03907 Boehringer Ingelheim Investigational Site
Milano, Italy
1200.43.03903 Boehringer Ingelheim Investigational Site
Napoli, Italy
1200.43.03905 Boehringer Ingelheim Investigational Site
Palermo, Italy
1200.43.03902 Boehringer Ingelheim Investigational Site
Savona, Italy
1200.43.03904 Boehringer Ingelheim Investigational Site
Taormina (me), Italy
1200.43.03906 Boehringer Ingelheim Investigational Site
Venezia, Italy
1200.43.03910 Boehringer Ingelheim Investigational Site
Viterbo, Italy
Japan
1200.43.08111 Boehringer Ingelheim Investigational Site
Akashi, Hyogo, Japan
1200.43.08109 Boehringer Ingelheim Investigational Site
Isehara, Kanagawa, Japan
1200.43.08103 Boehringer Ingelheim Investigational Site
Kashiwa, Chiba, Japan
1200.43.08107 Boehringer Ingelheim Investigational Site
Kobe, Hyogo, Japan
1200.43.08113 Boehringer Ingelheim Investigational Site
Koto-ku, Tokyo, Japan
1200.43.08108 Boehringer Ingelheim Investigational Site
Matsuyama, Ehime, Japan
1200.43.08104 Boehringer Ingelheim Investigational Site
Meguro-ku, Tokyo, Japan
1200.43.08112 Boehringer Ingelheim Investigational Site
Minato-ku, Tokyo, Japan
1200.43.08106 Boehringer Ingelheim Investigational Site
Nagoya, Aichi, Japan
1200.43.08114 Boehringer Ingelheim Investigational Site
Natori, Miyagi, Japan
1200.43.08110 Boehringer Ingelheim Investigational Site
Osaka, Osaka, Japan
1200.43.08102 Boehringer Ingelheim Investigational Site
shimotsuke,Tochigi, Japan
1200.43.08105 Boehringer Ingelheim Investigational Site
Sunto-gun, Shizuoka, Japan
Mexico
1200.43.05202 Boehringer Ingelheim Investigational Site
Mexico, Mexico
Russian Federation
1200.43.00704 Boehringer Ingelheim Investigational Site
Ivanovo, Russian Federation
1200.43.00706 Boehringer Ingelheim Investigational Site
Kurski, Russian Federation
1200.43.00709 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
1200.43.00703 Boehringer Ingelheim Investigational Site
Omsk, Russian Federation
1200.43.00710 Boehringer Ingelheim Investigational Site
Pyatigorsk, Russian Federation
1200.43.00707 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
1200.43.00705 Boehringer Ingelheim Investigational Site
Ufa, Russian Federation
South Africa
1200.43.02703 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
1200.43.02704 Boehringer Ingelheim Investigational Site
Kraaifontein, Cape Town, South Africa
1200.43.02701 Boehringer Ingelheim Investigational Site
Parktown, Johannesburg, South Africa
1200.43.02702 Boehringer Ingelheim Investigational Site
Pretoria, South Africa
Spain
1200.43.03401 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1200.43.03404 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1200.43.03405 Boehringer Ingelheim Investigational Site
Girona, Spain
1200.43.03406 Boehringer Ingelheim Investigational Site
Málaga, Spain
1200.43.03402 Boehringer Ingelheim Investigational Site
Salamanca, Spain
1200.43.03403 Boehringer Ingelheim Investigational Site
Zaragoza, Spain
Sweden
1200.43.04602 Boehringer Ingelheim Investigational Site
Göteborg, Sweden
Switzerland
1200.43.04102 Boehringer Ingelheim Investigational Site
Bern, Switzerland
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01345682     History of Changes
Other Study ID Numbers: 1200.43  2011-000391-34 
Study First Received: April 28, 2011
Results First Received: March 13, 2015
Last Updated: May 16, 2016
Health Authority: Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia Medica
Austria: Medicines and Medical Devices Agency
Belgium: Federal Agency for Medicinal and Health Products
Brazil: National Health Surveillance Agency
Czech Republic: State Institute for Drug Control
Denmark: The Danish Health and Medicines Authority
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ethics Committee
Israel: Ministry of Health
Italy: Ethics Committee
Japan: Pharmaceuticals and Medical Devices Agency
Mexico: Federal Commission for Protection Against Health Risks
Russia: Pharmacological Committee, Ministry of Health
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Switzerland: Swissmedic
United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Head and Neck Neoplasms
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Neoplasms, Squamous Cell
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 22, 2016