Colon CancerPhase 2NCT01111604
A Study of Ramucirumab or Icrucumab in Colorectal Cancer
A Phase 2 study testing Ramucirumab, Icrucumab and mFOLFOX-6 in people with Colon Cancer and Rectal Cancer, run by Eli Lilly and Company at 17 sites in 2 countries.
Trial summary
The purpose of this study is to determine if participants with metastatic colorectal cancer live longer without their cancer progressing when treated with standard chemotherapy, standard chemotherapy plus ramucirumab, or standard chemotherapy plus icrucumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Rectal Cancer
- What is being tested?
- Ramucirumab, Icrucumab and mFOLFOX-6
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 17 sitesin 2 countries
- Study dates
- Aug 2010to Dec 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Disease progression on an irinotecan-based first-line chemotherapy regimen (ie FOLFIRI or CAPIRI [capecitabine + irinotecan], with or without bevacizumab)
- Age ≥ 18 years
- Life expectancy of ≥ 6 months
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1 at study entry
- Agrees to adequate contraception during the study period and for 12 weeks after the last dose of study medication
- Provided signed informed consent
Who cannot join
- Has received prior oxaliplatin-based chemotherapy for locally advanced unresectable or metastatic Colorectal Cancer (CRC) (Prior oxaliplatin-based adjuvant chemotherapy is allowed if the last dose of oxaliplatin was administered > 12 months prior to randomization)
- Has documented and/or symptomatic brain or leptomeningeal metastases
- Has an ongoing or active infection, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders
- On chronic non-topical corticosteroid treatment. A participant discontinuing such treatment > 3 months prior to randomization is eligible
- Has uncontrolled or poorly controlled hypertension on a standard regimen of antihypertensive therapy
- Has a concurrent active malignancy. A participant with previous history of malignancy is eligible, provided that he/she has been disease free for > 3 years
Show all 12Show fewer
- If female, is pregnant (confirmed by serum beta human chorionic gonadotropin [βHCG] test) or lactating
- Has received a prior autologous or allogeneic organ or tissue transplantation
- Has undergone major surgery within 28 days prior to randomization
- Has had a serious nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization
- Has an elective or planned major surgery to be performed during the course of the trial
- Has a history of inflammatory bowel disease requiring pharmacological and/or surgical intervention in the 12 months prior to randomization
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
Canada14 sites
ImClone Investigational Site
Calgary, Alberta, T2N 4N2
ImClone Investigational Site
Edmonton, Alberta, T6G 1Z2
ImClone Investigational Site
Halifax, Nova Scotia, B3H 1V7
ImClone Investigational Site
Hamilton, Ontario, L8V 5C2
ImClone Investigational Site
Kelowna, British Columbia, V1Y 5L3
ImClone Investigational Site
London, Ontario, N6A 4L6
ImClone Investigational Site
Mississauga, Ontario, L5M 2N1
ImClone Investigational Site
Montreal, Quebec, H2W 156
ImClone Investigational Site
Oshawa, Ontario, L1G 2B9
ImClone Investigational Site
Ottawa, Ontario, K1H 8L6
ImClone Investigational Site
Surrey, British Columbia, V3V 1Z2
ImClone Investigational Site
Toronto, Ontario, M5G 2M9
ImClone Investigational Site
Vancouver, British Columbia, V5Z 4E6
ImClone Investigational Site
Windsor, Ontario, N8W 2X3
United States3 sites
ImClone Investigational Site
Cincinnati, Ohio, 45242
ImClone Investigational Site
Columbia, South Carolina, 29210
ImClone Investigational Site
Nashville, Tennessee, 37232
About this study
Official title: An Open-label, Multicenter, Randomized Phase 2 Study Evaluating the Safety and Efficacy of 5 FU/FA and Oxaliplatin (Modified FOLFOX 6) in Combination With Ramucirumab or IMC-18F1 or Without Investigational Therapy as Second Line Therapy in Patients With Metastatic Colorectal Cancer Following Disease Progression on First Line Irinotecan-based Therapy
The purpose of this study is to determine if participants with metastatic colorectal cancer live longer without their cancer progressing when treated with standard chemotherapy, standard chemotherapy plus ramucirumab, or standard chemotherapy plus icrucumab.
Read the detailed description
The purpose of this study is to evaluate the progression-free survival (PFS) in participants with metastatic colorectal cancer when treated with 1 of 3 modified FOLFOX-6 (folinic acid [FA] + fluorouracil [5-FU] + oxaliplatin [mFOLFOX-6])-based regimens, as second-line therapy.
During 2010, there has been an identified shortage of injectable folinic acid (FA) in the United States. Levo-folinic acid (LFA) will be allowed as a substitute for FA in the mFOLFOX-6 chemotherapy regimen in circumstances in which FA is not available, to facilitate continuity of participant care.
- Conditions
- Colon Cancer, Rectal Cancer
- Being tested
- Ramucirumab, Icrucumab, mFOLFOX-6
- Keywords
- Colonic Neoplasms, Rectal Neoplasms, Adenocarcinoma, Antibodies, Monoclonal
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamucirumabBiological
Also called IMC-1121B, LY3009806
8 mg/kg IV Q2W
IcrucumabBiological
Also called IMC-18F1, LY3012212
15 mg/kg IV Q2W
mFOLFOX-6Drug
Oxaliplatin: 85 milligram per square meter (mg/m²) IV every 2 weeks (Q2W)
FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W
| Study group | Role | What they receive |
|---|---|---|
| mFOLFOX-6 | Active comparator | mFOLFOX-6 Receives: Drug: mFOLFOX-6 |
| mFOLFOX-6 + Ramucirumab | Experimental | mFOLFOX-6 + Ramucirumab Receives: Biological: Ramucirumab; Drug: mFOLFOX-6 |
| mFOLFOX-6 + Icrucumab | Experimental | mFOLFOX-6 + Icrucumab Receives: Biological: Icrucumab; Drug: mFOLFOX-6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
PFS is defined as the time from baseline until the date of disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1), or death from any cause, whichever was first. Participants who die without a reported prior progression will be considered to have progressed on the day of their death. Participants who did not progress, are lost to follow-up, or have missed two or more scheduled tumor assessments will be censored at the day of their last radiographic tumor assessment, if there are no post-baseline tumor measurements for a randomized and treated participant, the participant will be censored at the date of randomization. If death or progressive disease (PD) occurs after 2 or more missing radiographic visits, censoring will occur at the date of the last radiographic visit prior to the last visit.
Measured: Baseline until Disease Progression or Death from Any Cause (Up to 95 Weeks)
Secondary outcomes (14)
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
The ORR is the percentage of participants with Complete Response (CR, the disappearance of target lesions and any pathological lymph nodes [target or non-target] taking as reference the baseline sum of diameters in response to treatment) or Partial Response (PR, at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters in response to treatment) according to RECIST v1.1 from the start of the treatment until disease progression.
Measured: Baseline until Disease Progression (Up to 95 Weeks)
Overall Survival (OS)
Overall survival is defined as the time from baseline to the date of death from any cause. If the participant is alive at the end of the follow-up period or is lost to follow-up, OS will be censored on the last date the participant is known to be alive.
Measured: Baseline Until Death from Any Cause (Up to 163 Weeks)
Duration of Response (DoR)
DoR was measured from the time measurement criteria are first met for Complete Response or Partial Response or until the first date that the criteria for disease progression or death from any cause. whichever is first recorded. As defined according to RECIST v1.1, CR is the disappearance of all non-nodal target lesions, and PR is the short axes of any target lymph nodes reduced to < 10 mm and at least a 30% decrease in the sum of the diameters of target lesions including the short axes of any target lymph nodes.)
Measured: Criteria First Met for CR or PR until Disease Progression or Death from Any Cause (Up to 95 Weeks)
Pharmacokinetics (PK): Maximum Concentration (Cmax) at Cycle 5
Maximum concentration (1 hour post end of infusion, Cmax) is the concentration measured in serum.
Measured: Cycle 5, 1 Hour Post End of Infusion
Pharmacokinetics (PK): Trough Serum Concentrations (Ctrough) at Cycle 5
Trough (prior to infusion, Ctrough) concentrations measured in serum.
Measured: Cycle 5, Prior to Infusion
Maximum Concentration (Cmax) at Day 8
Maximum concentration (Cmax) is the maximum peak concentration measured in blood plasma after drug infusion.
Measured: Day 8 (cycles 1 and 5)
Maximum Concentration (Cmax) at Day 15
Cmax is the maximum peak concentration measured in blood plasma after drug infusion.
Measured: Day 15 (Cycles 1 and 5)
Minimum Concentration (Cmin) at Day 1
Cmin is the minimum peak concentration measured in blood plasma after drug infusion.
Measured: Day 1 (cycles 1, 5, 9, and 13)
Minimum Concentration (Cmin) at Day 4
Cmin is the minimum peak concentration measured in blood plasma after drug infusion.
Measured: Day 4 (cycles 1 and 5)
Minimum Concentration (Cmin) at Day 8
Minimum concentration (Cmin) is the minimum peak concentration measured in blood plasma after drug infusion.
Measured: Day 8 (cycles 1 and 5)
Minimum Concentration (Cmin) at Day 15
Minimum concentration (Cmin) is the minimum peak concentration measured in blood plasma after drug infusion.
Measured: Day 15 (cycles 1 and 5)
Number of Participants With Serum Ramucirumab Antibody Assessment
A sample will be considered positive for anti-Ramucirumab antibodies if it exhibits a post-baseline antibody level exceeding the normal anti-Ramucirumab antibody level seen in healthy untreated individuals.
Measured: 31 Weeks
Serum Anti-Icrucumab Antibody Assessment
A sample will be considered positive for anti-icrucumab antibodies if it exhibits a post-baseline antibody level exceeding the normal anti-icrucumab antibody level seen in healthy untreated individuals.
Measured: 31 Weeks
Number of Participants With Adverse Events
A summary of serious AEs (SAEs) and all other non-serious AEs regardless of causality, is located in the Reported Adverse Events module.
Measured: Baseline up to 165 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01111604
- Sponsor's protocol ID
- 13942
- Other IDs
- CP20-0801, I4Y-IE-JCDB
- Status last verified
- Jul 2019
- First submitted
- 8 Apr 2010
- Last updated
- 6 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Moore M, Gill S, Asmis T, Berry S, Burkes R, Zbuk K, Alcindor T, Jeyakumar A, Chan T, Rao S, Spratlin J, Tang PA, Rothenstein J, Chan E, Bendell J, Kudrik F, Kauh J, Tang S, Gao L, Kambhampati SR, Nasroulah F, Yang L, Ramdas N, Binder P, Strevel E. Randomized phase II study of modified FOLFOX-6 in combination with ramucirumab or icrucumab as second-line therapy in patients with metastatic colorectal cancer after disease progression on first-line irinotecan-based therapy. Ann Oncol. 2016 Dec;27(12):2216-2224. doi: 10.1093/annonc/mdw412. Epub 2016 Oct 11.
PubMed 27733377
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Randomized Phase 2 Study Evaluating the Safety and Efficacy of 5 FU/FA and Oxaliplatin (Modified FOLFOX 6) in Combination With Ramucirumab or IMC-18F1 or Without Investigational Therapy as Second Line Therapy in Patients With Metastatic Colorectal Cancer Following Disease Progression on First Line Irinotecan-based Therapy
- ClinicalTrials.gov ID
- NCT01111604
- Acronym / sponsor ID
- 13942
- Conditions
- Colon Cancer, Rectal Cancer
- Keywords
- Colonic Neoplasms, Rectal Neoplasms, Adenocarcinoma, Antibodies, Monoclonal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 27 Apr 2010 (estimated)
- Results
- Posted 6 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if participants with metastatic colorectal cancer live longer without their cancer progressing when treated with standard chemotherapy, standard chemotherapy plus ramucirumab, or standard chemotherapy plus icrucumab.
Detailed description
The purpose of this study is to evaluate the progression-free survival (PFS) in participants with metastatic colorectal cancer when treated with 1 of 3 modified FOLFOX-6 (folinic acid [FA] + fluorouracil [5-FU] + oxaliplatin [mFOLFOX-6])-based regimens, as second-line therapy.
During 2010, there has been an identified shortage of injectable folinic acid (FA) in the United States. Levo-folinic acid (LFA) will be allowed as a substitute for FA in the mFOLFOX-6 chemotherapy regimen in circumstances in which FA is not available, to facilitate continuity of participant care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mFOLFOX-6 | Active comparator | Drug: mFOLFOX-6mFOLFOX-6 |
| mFOLFOX-6 + Ramucirumab | Experimental | Biological: Ramucirumab, Drug: mFOLFOX-6mFOLFOX-6 + Ramucirumab |
| mFOLFOX-6 + Icrucumab | Experimental | Biological: Icrucumab, Drug: mFOLFOX-6mFOLFOX-6 + Icrucumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Disease progression on an irinotecan-based first-line chemotherapy regimen (ie FOLFIRI or CAPIRI [capecitabine + irinotecan], with or without bevacizumab)
- Age ≥ 18 years
- Life expectancy of ≥ 6 months
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1 at study entry
- Agrees to adequate contraception during the study period and for 12 weeks after the last dose of study medication
Key exclusion criteria (12 listed)
- Has received prior oxaliplatin-based chemotherapy for locally advanced unresectable or metastatic Colorectal Cancer (CRC) (Prior oxaliplatin-based adjuvant chemotherapy is allowed if the last dose of oxaliplatin was administered > 12 months prior to randomization)
- Has documented and/or symptomatic brain or leptomeningeal metastases
- Has an ongoing or active infection, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders
- On chronic non-topical corticosteroid treatment. A participant discontinuing such treatment > 3 months prior to randomization is eligible
- Has uncontrolled or poorly controlled hypertension on a standard regimen of antihypertensive therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RamucirumabAlso: IMC-1121B, LY30098068 mg/kg IV Q2W | Biological | mFOLFOX-6 + Ramucirumab |
| IcrucumabAlso: IMC-18F1, LY301221215 mg/kg IV Q2W | Biological | mFOLFOX-6 + Icrucumab |
| mFOLFOX-6Oxaliplatin: 85 milligram per square meter (mg/m²) IV every 2 weeks (Q2W) FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable). 5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W | Drug | mFOLFOX-6, mFOLFOX-6 + Icrucumab, mFOLFOX-6 + Ramucirumab |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Baseline until Disease Progression or Death from Any Cause (Up to 95 Weeks)
PFS is defined as the time from baseline until the date of disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1), or death from any cause, whichever was first. Participants who die without a reported prior progression will be considered to have progressed on the day of their death. Participants who did not progress, are lost to follow-up, or have missed two or more scheduled tumor assessments will be censored at the day of their last radiographic tumor assessment, if there are no post-baseline tumor measurements for a randomized and treated participant, the participant will be censored at the date of randomization. If death or progressive disease (PD) occurs after 2 or more missing radiographic visits, censoring will occur at the date of the last radiographic visit prior to the last visit.
14 secondary outcomes
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
Time frame: Baseline until Disease Progression (Up to 95 Weeks)
Overall Survival (OS)
Time frame: Baseline Until Death from Any Cause (Up to 163 Weeks)
Duration of Response (DoR)
Time frame: Criteria First Met for CR or PR until Disease Progression or Death from Any Cause (Up to 95 Weeks)
Pharmacokinetics (PK): Maximum Concentration (Cmax) at Cycle 5
Time frame: Cycle 5, 1 Hour Post End of Infusion
Pharmacokinetics (PK): Trough Serum Concentrations (Ctrough) at Cycle 5
Time frame: Cycle 5, Prior to Infusion
Maximum Concentration (Cmax) at Day 8
Time frame: Day 8 (cycles 1 and 5)
Maximum Concentration (Cmax) at Day 15
Time frame: Day 15 (Cycles 1 and 5)
Minimum Concentration (Cmin) at Day 1
Time frame: Day 1 (cycles 1, 5, 9, and 13)
Minimum Concentration (Cmin) at Day 4
Time frame: Day 4 (cycles 1 and 5)
Minimum Concentration (Cmin) at Day 8
Time frame: Day 8 (cycles 1 and 5)
Minimum Concentration (Cmin) at Day 15
Time frame: Day 15 (cycles 1 and 5)
Number of Participants With Serum Ramucirumab Antibody Assessment
Time frame: 31 Weeks
Serum Anti-Icrucumab Antibody Assessment
Time frame: 31 Weeks
Number of Participants With Adverse Events
Time frame: Baseline up to 165 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27733377Moore M, Gill S, Asmis T, Berry S, Burkes R, Zbuk K, Alcindor T, Jeyakumar A, Chan T, Rao S, Spratlin J, Tang PA, Rothenstein J, Chan E, Bendell J, Kudrik F, Kauh J, Tang S, Gao L, Kambhampati SR, Nasroulah F, Yang L, Ramdas N, Binder P, Strevel E. Randomized phase II study of modified FOLFOX-6 in combination with ramucirumab or icrucumab as second-line therapy in patients with metastatic colorectal cancer after disease progression on first-line irinotecan-based therapy. Ann Oncol. 2016 Dec;27(12):2216-2224. doi: 10.1093/annonc/mdw412. Epub 2016 Oct 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ramucirumab, Icrucumab and mFOLFOX-6 in people with Colon Cancer and Rectal Cancer, run by Eli Lilly and Company at 17 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: Baseline until Disease Progression or Death from Any Cause (Up to 95 Weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01111604, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2019.