Squamous Cell Carcinoma of Head and NeckPhase 2NCT00756444
A Randomized Phase 2 Pharmacokinetic Trial of Chemotherapy With or Without Panitumumab in Patients With Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck
A Phase 2 study testing Panitumumab, Cisplatin and 5FU in people with Squamous Cell Carcinoma of Head and Neck, run by Amgen.
Trial summary
Study 20080008 was a PK sub-study to study 20050251[Japan 20050251A]. This PK protocol was amended 20-March-2009 and is now a Phase 2 stand alone study. There are no sites participating in the U.S. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of Head and Neck
- What is being tested?
- Panitumumab, Cisplatin and 5FU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- 21 Oct 2008to 30 Mar 2012
- 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
- Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (SCCHN) or its variants (eg, basaloid squamous cell carcinoma and adenosquamous cell carcinoma) of the oral cavity, oropharynx, hypopharynx, or larynx
- Diagnosis of metastatic disease and/or recurrent disease following locoregional therapy and determined to be incurable by surgery or radiotherapy
- Subjects who have received radiation as primary therapy are eligible if locoregional recurrence is in the field of radiation and has occurred ≥6 months after the completion of radiation therapy. Subjects whose locoregional recurrence is solely outside the field of radiation are eligible if the recurrence has occurred ≥ 3 months after the completion of radiation therapy.
- Measurable or non measurable disease. Target lesions must not be chosen from a previously irradiated field unless there has been radiographically and/or pathologically documented tumor progression in that lesion prior to randomization.
- Eastern cooperative oncology group (ECOG) performance status of 0 or 1
- Man or woman ≥ 18 years of age
Show all 13Show fewer
- Hematological function, as follows (≤ 10 days prior to randomization):
- Absolute neutrophil count (ANC) ≥1.5 x 109/L Platelet count ≥ 100 x 109/L Hemoglobin ≥ 9 g/dL - Renal function, as follows (≤ 10 days prior to randomization):
- Creatinine clearance (CrCl) ≥ 50 mL/min calculated by the Cockcroft Gault method as follows:
- Male creatinine clearance = (140 age) x (weight in Kg) / (serum Cr x 72) Female creatinine clearance = (140 age) x (weight in Kg) x 0.85 / (serum Cr x 72)
- Hepatic function, as follows (≤ 10 days prior to randomization): Aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN) (≤ 5 x ULN if liver metastases) Alanine aminotransferase (ALT) ≤ 3 x ULN (≤ 5 x ULN if liver metastases) Total bilirubin ≤ 1.5 x ULN
- Electrolytes, as follows (≤ 10 days prior to randomization): Magnesium ≥ lower limit of normal (LLN)
- Negative pregnancy test ≤ 72 hours prior to randomization (females of childbearing potential only)
Who cannot join
- Documented or symptomatic central nervous system metastases
- History of another primary cancer, except:
- Curatively treated in situ cervical cancer, or Curatively resected non melanoma skin cancer, or Other primary solid tumor curatively treated with no known active disease present and no treatment administered for ≥ 2 years prior to randomization
- Subjects whose only site of metastatic disease is a single spiculated lung nodule are assumed to have a second lung primary and are excluded unless there is unequivocal pathological confirmation of metastasis of the SCCHN primary
- Nasopharyngeal carcinoma
- Prior systemic treatment for metastatic and/or recurrent SCCHN Subjects with recurrent disease may have received re irradiation; however subjects who received chemotherapy concomitantly with re irradiation are excluded
Show all 27Show fewer
- Prior systemic chemotherapy for SCCHN as part of the initial multimodality treatment for locally advanced disease if completed < 6 months prior to randomization
- Prior cisplatin containing induction chemotherapy followed by cisplatin containing chemoradiotherapy
- Prior anti EGFr antibody therapy (eg, cetuximab) or treatment with small molecule EGFr inhibitors (eg, gefitinib, erlotinib, lapatinib)
- Subjects requiring immunosuppressive agents (eg, methotrexate and cyclosporine), however corticosteroids are allowed
- Known allergy or hypersensitivity to any component of the study drugs
- Major surgery requiring general anesthesia and a significant incision (ie, larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy) ≤ 28 days or minor surgery (excluding central venous catheter placement, percutaneous feeding tube, and biopsy) ≤ 14 days prior to randomization. Subjects must have recovered from surgery related toxicities.
- Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year prior to randomization
- History of interstitial lung disease eg, pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest computerized tomography (CT) scan
- Symptomatic peripheral neuropathy grade ≥ 2 based on the Common Terminology Criteria for Adverse Events (CTCAE) v3.0
- Grade ≥ 3 hearing loss based on the CTCAE v3.0 Auditory/Ear (Hearing [without monitoring program])
- Subjects not recovered from all previous acute radiotherapy related toxicities
- Active infection requiring systemic treatment or any uncontrolled infection ≤ 14 days prior to randomization
- Known positive test for human immunodeficiency virus (HIV) infection, hepatitis C virus, chronic hepatitis B infection (testing is not required in the absence of clinical suspicion)
- Any co morbid condition that would increase risk of toxicity (eg, suspected or confirmed dihydropyrimidine deficiency)
- Other investigational procedures are excluded
- Subject currently is enrolled in or ≤ 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agents(s)
- Subject who is pregnant or breast feeding
- Man or woman of child bearing potential not consenting to use adequate contraceptive precautions ie, double barrier contraceptive methods (eg, diaphragm plus condom) during the course of the study and for 6 months after the last investigational product(s) administration for women, and 1 month for men
- Subject unwilling or unable to comply with study requirements
- Previously randomized into this study or Amgen study 20050251
- Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
About this study
Official title: A Randomized Phase 2 Pharmacokinetic Trial of Chemotherapy With or Without Panitumumab in Patients With Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck (Amended Version 20-March-2009)
Study 20080008 was a PK sub-study to study 20050251[Japan 20050251A]. This PK protocol was amended 20-March-2009 and is now a Phase 2 stand alone study. There are no sites participating in the U.S.
This study is designed to estimate the effect of panitumumab on the PK of cisplatin and 5-FU in subjects receiving cisplatin and 5-FU with or without panitumumab.
To maximize any potential effect of panitumumab on the PK of cisplatin and 5-FU, the collection of PK samples of cisplatin and 5-FU will be taken during cycle 2 of the study, the point at which the PK of panitumumab is expected to be at steady-state after a dose of 9 mg/kg given every 3 weeks.
Read the detailed description
Study Phase: 2 Indication: Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck Primary Objective: To estimate the effect of administration of 9 mg/kg Q3W of panitumumab on the area under the curve (AUC) of total plasma cisplatin-derived platinum levels and the average concentration at steady state (Css) of 5-fluorouracil (5-FU) in subjects who are receiving cisplatin and 5-FU.
Secondary Objective(s): To estimate the effect of administration of 9 mg/kg Q3W of panitumumab on the maximum concentration (Cmax) of total plasma cisplatin-derived platinum levels, AUC and Cmax of free plasma cisplatin-derived platinum in subjects who are receiving cisplatin and 5-FU.
Hypotheses: This is an estimation sub-study rather than formal hypothesis testing, the following will be estimated:
- The effect of administration of 9 mg/kg Q3W of panitumumab at steady state on the pharmacokinetics of cisplatin will be estimated based on the ratio for AUC with:without panitumumab of total plasma cisplatin-derived platinum levels. Total plasma cisplatin-derived platinum levels will be the focus since it has been shown in the literature that there are correlations between total plasma cisplatin-derived platinum levels and nephrotoxicity and tumor response (Desoize et al, 1991).
- The effect of administration of 9 mg/kg Q3W of panitumumab at steady state on the pharmacokinetics of 5-FU assessed based on the average concentration at steady state (Css) of 5-FU.
Study Design: Study 20080008 is a PK study.
This study is designed to estimate the effect of panitumumab on the PK of cisplatin and 5-FU in subjects receiving cisplatin and 5-FU with or without panitumumab.
To maximize any potential effect of panitumumab on the PK of cisplatin and 5-FU, the collection of PK samples of cisplatin and 5-FU will be taken during cycle 2 of the study, the point at which the PK of panitumumab is expected to be at steady-state after a dose of 9 mg/kg given every 3 weeks.
Primary and Secondary Endpoints: The primary endpoints for this study are the ratio of geometric means (with:without panitumumab) for AUC of total plasma cisplatin-derived platinum and average concentration at steady sate (Css) of 5-FU measured at cycle 2 at which time panitumumab levels are anticipated to be at steady state. Secondary endpoints are the ratio of geometric means (with:without panitumumab) for 1) Cmax of total plasma cisplatin-derived platinum and 2) Cmax and AUC of free plasma cisplatin-derived platinum measured at cycle 2.
Sample Size: Approximately 45 subjects will participate in Study 20080008. At least fifteen evaluable subjects (defined as providing sufficient PK samples to permit calculation of AUC for total plasma cisplatin-derived platinum and average concentration at steady state for 5-FU in cycle 2) per arm will be required. Additional subjects will be sequentially included until at least fifteen evaluable subjects per arm are achieved. It is therefore estimated that approximately 45 subjects will need to participate in the study to obtain 30 evauable subjects.
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Being tested
- Panitumumab, Cisplatin, 5FU
- Keywords
- PK Study, Metastatic Recurrent
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PanitumumabDrug
This is a PK study comparing Panitumumab plus Chemotherapy to Chemotherapy alone
CisplatinDrug
This is a PK study comparing Panitumumab plus Chemotherapy to Chemotherapy alone
5FUDrug
This is a PK study comparing Panitumumab plus Chemotherapy to Chemotherapy alone
| Study group | Role | What they receive |
|---|---|---|
| Panitumumab plus Chemotherapy | Active comparator | Subjects receiving cisplatin and 5/FU and receiving Panitumumab who have with Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck Receives: Drug: Panitumumab |
| Chemotherapy Alone | Active comparator | Subjects receiving cisplatin and 5/FU and not receiving Panitumumab who have with Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck Receives: Drug: Cisplatin; Drug: 5FU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC) of Total Plasma Cisplatin-derived Platinum Levels With and Without the Presence of Panitumumab
AUC refers to area under the concentration curve from time 0 to last measurable concentration. AUC of total plasma cisplatin-derived platinum levels is estimated both for subjects receiving cisplatin with panitumumab and for subjects receiving cisplatin without panitumumab.
Measured: Levels measured at 0.5, 1, 2, 3, 4, 6 and 24 hours following start of cycle 2 cisplatin infusion
Steady-state Plasma Concentrations (Css) for 5-FU With and Without the Presence of Panitumumab
Steady-state plasma concentrations (Css) of 5-FU were estimated as the mean of two or more evaluable concentrations at 24, 72, and 96 hours after the start of 5-FU infusion. Css is estimated both for subjects receiving 5-FU with panitumumab and for subjects receiving 5-FU without panitumumab
Measured: 24 to 96 hours following start of cycle 2 infusion with 5-FU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2008 (estimated)
- Study start21 Oct 2008
- Primary completion30 Mar 2012
- Study completion30 Mar 2012
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.
- Other trials for Squamous Cell Carcinoma of Head and NeckStudies of the same condition, open and under way.
- More trials run by AmgenThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00756444
- Sponsor's protocol ID
- 20080008
- Status last verified
- Oct 2018
- First submitted
- 18 Sep 2008
- Last updated
- 15 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 2 Pharmacokinetic Trial of Chemotherapy With or Without Panitumumab in Patients With Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck (Amended Version 20-March-2009)
- ClinicalTrials.gov ID
- NCT00756444
- Acronym / sponsor ID
- 20080008
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Keywords
- PK Study, Metastatic Recurrent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Collaborators
- Takeda
- Study start
- 21 Oct 2008 (actual)
- Primary completion
- 30 Mar 2012 (actual)
- Study completion
- 30 Mar 2012 (actual)
- First posted
- 22 Sep 2008 (estimated)
- Results
- Posted 13 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study 20080008 was a PK sub-study to study 20050251[Japan 20050251A]. This PK protocol was amended 20-March-2009 and is now a Phase 2 stand alone study. There are no sites participating in the U.S.
This study is designed to estimate the effect of panitumumab on the PK of cisplatin and 5-FU in subjects receiving cisplatin and 5-FU with or without panitumumab.
To maximize any potential effect of panitumumab on the PK of cisplatin and 5-FU, the collection of PK samples of cisplatin and 5-FU will be taken during cycle 2 of the study, the point at which the PK of panitumumab is expected to be at steady-state after a dose of 9 mg/kg given every 3 weeks.
Detailed description
Study Phase: 2 Indication: Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck Primary Objective: To estimate the effect of administration of 9 mg/kg Q3W of panitumumab on the area under the curve (AUC) of total plasma cisplatin-derived platinum levels and the average concentration at steady state (Css) of 5-fluorouracil (5-FU) in subjects who are receiving cisplatin and 5-FU.
Secondary Objective(s): To estimate the effect of administration of 9 mg/kg Q3W of panitumumab on the maximum concentration (Cmax) of total plasma cisplatin-derived platinum levels, AUC and Cmax of free plasma cisplatin-derived platinum in subjects who are receiving cisplatin and 5-FU.
Hypotheses: This is an estimation sub-study rather than formal hypothesis testing, the following will be estimated:
- The effect of administration of 9 mg/kg Q3W of panitumumab at steady state on the pharmacokinetics of cisplatin will be estimated based on the ratio for AUC with:without panitumumab of total plasma cisplatin-derived platinum levels. Total plasma cisplatin-derived platinum levels will be the focus since it has been shown in the literature that there are correlations between total plasma cisplatin-derived platinum levels and nephrotoxicity and tumor response (Desoize et al, 1991).
- The effect of administration of 9 mg/kg Q3W of panitumumab at steady state on the pharmacokinetics of 5-FU assessed based on the average concentration at steady state (Css) of 5-FU.
Study Design: Study 20080008 is a PK study.
This study is designed to estimate the effect of panitumumab on the PK of cisplatin and 5-FU in subjects receiving cisplatin and 5-FU with or without panitumumab.
To maximize any potential effect of panitumumab on the PK of cisplatin and 5-FU, the collection of PK samples of cisplatin and 5-FU will be taken during cycle 2 of the study, the point at which the PK of panitumumab is expected to be at steady-state after a dose of 9 mg/kg given every 3 weeks.
Primary and Secondary Endpoints: The primary endpoints for this study are the ratio of geometric means (with:without panitumumab) for AUC of total plasma cisplatin-derived platinum and average concentration at steady sate (Css) of 5-FU measured at cycle 2 at which time panitumumab levels are anticipated to be at steady state. Secondary endpoints are the ratio of geometric means (with:without panitumumab) for 1) Cmax of total plasma cisplatin-derived platinum and 2) Cmax and AUC of free plasma cisplatin-derived platinum measured at cycle 2.
Sample Size: Approximately 45 subjects will participate in Study 20080008. At least fifteen evaluable subjects (defined as providing sufficient PK samples to permit calculation of AUC for total plasma cisplatin-derived platinum and average concentration at steady state for 5-FU in cycle 2) per arm will be required. Additional subjects will be sequentially included until at least fifteen evaluable subjects per arm are achieved. It is therefore estimated that approximately 45 subjects will need to participate in the study to obtain 30 evauable subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Panitumumab plus Chemotherapy | Active comparator | Drug: PanitumumabSubjects receiving cisplatin and 5/FU and receiving Panitumumab who have with Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck |
| Chemotherapy Alone | Active comparator | Drug: Cisplatin, Drug: 5FUSubjects receiving cisplatin and 5/FU and not receiving Panitumumab who have with Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (SCCHN) or its variants (eg, basaloid squamous cell carcinoma and adenosquamous cell carcinoma) of the oral cavity, oropharynx, hypopharynx, or larynx
- Diagnosis of metastatic disease and/or recurrent disease following locoregional therapy and determined to be incurable by surgery or radiotherapy
- Subjects who have received radiation as primary therapy are eligible if locoregional recurrence is in the field of radiation and has occurred ≥6 months after the completion of radiation therapy. Subjects whose locoregional recurrence is solely outside the field of radiation are eligible if the recurrence has occurred ≥ 3 months after the completion of radiation therapy.
- Measurable or non measurable disease. Target lesions must not be chosen from a previously irradiated field unless there has been radiographically and/or pathologically documented tumor progression in that lesion prior to randomization.
- Eastern cooperative oncology group (ECOG) performance status of 0 or 1
Key exclusion criteria (27 listed)
- Documented or symptomatic central nervous system metastases
- History of another primary cancer, except:
- Curatively treated in situ cervical cancer, or Curatively resected non melanoma skin cancer, or Other primary solid tumor curatively treated with no known active disease present and no treatment administered for ≥ 2 years prior to randomization
- Subjects whose only site of metastatic disease is a single spiculated lung nodule are assumed to have a second lung primary and are excluded unless there is unequivocal pathological confirmation of metastasis of the SCCHN primary
- Nasopharyngeal carcinoma
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 |
|---|---|---|
| PanitumumabThis is a PK study comparing Panitumumab plus Chemotherapy to Chemotherapy alone | Drug | Panitumumab plus Chemotherapy |
| CisplatinThis is a PK study comparing Panitumumab plus Chemotherapy to Chemotherapy alone | Drug | Chemotherapy Alone |
| 5FUThis is a PK study comparing Panitumumab plus Chemotherapy to Chemotherapy alone | Drug | Chemotherapy Alone |
Primary outcome
Area Under the Curve (AUC) of Total Plasma Cisplatin-derived Platinum Levels With and Without the Presence of Panitumumab
Time frame: Levels measured at 0.5, 1, 2, 3, 4, 6 and 24 hours following start of cycle 2 cisplatin infusion
AUC refers to area under the concentration curve from time 0 to last measurable concentration. AUC of total plasma cisplatin-derived platinum levels is estimated both for subjects receiving cisplatin with panitumumab and for subjects receiving cisplatin without panitumumab.
Steady-state Plasma Concentrations (Css) for 5-FU With and Without the Presence of Panitumumab
Time frame: 24 to 96 hours following start of cycle 2 infusion with 5-FU
Steady-state plasma concentrations (Css) of 5-FU were estimated as the mean of two or more evaluable concentrations at 24, 72, and 96 hours after the start of 5-FU infusion. Css is estimated both for subjects receiving 5-FU with panitumumab and for subjects receiving 5-FU without panitumumab
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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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.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Panitumumab, Cisplatin and 5FU in people with Squamous Cell Carcinoma of Head and Neck, run by Amgen.
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 13 inclusion and 27 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 15 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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 13 Dec 2013). 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?
Area Under the Curve (AUC) of Total Plasma Cisplatin-derived Platinum Levels With and Without the Presence of Panitumumab (time frame: Levels measured at 0.5, 1, 2, 3, 4, 6 and 24 hours following start of cycle 2 cisplatin infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2018.