Myelodysplastic SyndromePhase 1/2NCT00867061
Efficacy and Safety of 5-day Dosing of ON 01910.Na in Intermediate-1,-2, or High Risk Myelodysplastic Syndrome (MDS)
A Phase 1/2 study testing ON 01910.Na Concentrate in people with Myelodysplastic Syndrome, run by Traws Pharma, Inc. at 1 site in United States.
Trial summary
For MDS patients who have not responded to or have progressed after an initial response to DNA methyltransferase inhibitors (DNMTI) and are not stem cell transplant candidates, therapeutic options are limited. Participation in clinical trials such as this one may be considered. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndrome
- What is being tested?
- ON 01910.Na Concentrate
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Sep 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Diagnosis of MDS confirmed within 4 weeks prior to study entry according to the World Health Organization (WHO) Criteria or the French-American-British (FAB) Classification.
- IPSS score of at least 0.5 (Intermediate-1, Intermediate-2 or High Risk MDS)
- Failure of, or insufficient response to 5-azacitidine or decitabine administered for 4 to 6 cycles.
- Failed to respond to, relapsed following, or opted not to participate in bone marrow transplantation.
- Off all other treatments for MDS, including filgrastim (G-CSF) and erythropoietin for at least 2 weeks, and off standard or investigational MDS therapies for four weeks.
- ECOG Performance Status 0, 1 or 2.
Show all 10Show fewer
- Adequate contraceptive [including prescription oral contraceptives (birth control pills), contraceptive injections, intrauterine device (IUD), double-barrier method (spermicidal jelly or foam with condoms or diaphragm), contraceptive patch, or surgical sterilization] before entry and throughout the study for female patients of reproductive potential.
- Female patients with reproductive potential must have a negative serum beta-HCG pregnancy test at screening.
- Willing to adhere to the prohibitions and restrictions specified in this protocol.
- Patient (or his/her legally authorized representative) must have signed an informed consent document indicating that he/she understands the purpose of and procedures required for the study and is willing to participate in the study.
Who cannot join
- Anemia due to factors other than MDS (including hemolysis or gastrointestinal bleeding).
- Hypoplastic MDS (cellularity <10%).
- Any active malignancy within the past year except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast.
- History of HIV-1 seropositivity.
- Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia.
- Active infection not adequately responding to appropriate therapy.
Show all 18Show fewer
- Total bilirubin ≥ 1.5 mg/dL not related to hemolysis or Gilbert's disease, ALT or AST ≥ 2 X ULN.
- Serum creatinine ≥ 1.5 mg/dL or calculated creatinine clearance ≤ 60 ml/min/1.73 m2
- Ascites requiring active medical management including paracentesis, or hyponatremia (defined as serum sodium value of <134 Meq/L).
- Female patients who are pregnant or lactating.
- Male patients with female sexual partners who are unwilling to follow the strict contraception requirements described in this protocol.
- Major surgery without full recovery or major surgery within 3 weeks of ON 01910.Na treatment start.
- Uncontrolled hypertension (defined as a systolic pressure ≥ 160 and/or a diastolic pressure ≥ 110).
- New onset seizures (within 3 months prior to the first dose of ON 01910.Na) or poorly controlled seizures.
- Any concurrent investigational agent or chemotherapy, radiotherapy or immunotherapy.
- Treatment with myeloid growth factors or erythropoiesis stimulating agents (ESA) within 2 weeks of starting ON 01910.Na.
- Treatment with standard MDS therapies or investigational therapy within 4 weeks of starting ON 01910.Na.
- Psychiatric illness/social situations that would limit the patient's ability to tolerate and/or comply with study requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Phase 1/2, Single-Arm Study To Assess The Efficacy and Safety Of 5-day Continuous Intravenous Dosing Of ON 01910.Na Administered Every 2 Weeks in Patients With Intermediate-1, Intermediate-2, or High Risk Myelodysplastic Syndrome (MDS)
For MDS patients who have not responded to or have progressed after an initial response to DNA methyltransferase inhibitors (DNMTI) and are not stem cell transplant candidates, therapeutic options are limited. Participation in clinical trials such as this one may be considered. The specific objectives of this trial are to find out which dose of ON 01910.Na can be safety given to MDS patients and then find out if this dose of drug has any beneficial effects on the patients' disease. ON 01910.Na is a new, experimental drug; the reason for doing this trial is based on the anti-cancer activity of ON 01910.Na that has been observed in laboratory experiments and in early clinical trials.
Read the detailed description
This is a single center, open label, phase 1/2 study in which two to thirty three patients with Intermediate-1, Intermediate-2, or High risk MDS will receive ON 01910.Na as a intravenous continuous infusion (IVCI) over 24 hours for 5 consecutive days every 2 weeks.
In the phase 1 component of this trial the maximum tolerated dose of ON1910.Na in patients with Intermediate-1, Intermediate-2 or High Risk myelodysplastic syndromes will be determined. A standard "3+3" dose escalation scheme will be followed with up to six patients treated at the 800 mg/m2/day dose level. Patients will be observed for 2 cycles before dose escalation occurs. If none of the initial three patients in the 800 mg/m2/day cohort experience dose-limiting toxicity (DLT), during the first two cycles, then a new cohort of three patients will be treated at the 1500 mg/m2/day dose level. If none of the initial three patients in the 1500 mg/m2/day cohort experience DLT during the first two cycles, three additional patients will be treated at the 1500 mg/m2/day level. If no more than one of the six patients at the 1500 mg/m2/day dose level experiences a DLT, then that dose level will be confirmed as the MTD and no further dose escalation will occur.
If one of the three patients in the 800 mg/m2/day cohort experiences DLT during the first two cycles, then up to three additional patients will be treated at the same dose level. Escalation to 1500 mg/m2/day will proceed if only one of the six patients experiences DLT at the 800 mg/m2/day dose level. If two or more patients in the 800 mg/m2/day cohort experience DLT during the first two cycles, then the maximum tolerated dose (MTD) will have been exceeded, no further dose escalation will occur, and a full safety review will determine if further enrollment of patients will proceed.
If the 800 mg/m2/day dose level is under consideration as the MTD (i.e. if ≥ 2 patients experience DLT at the 1500 mg/m2/day dose level), and only three patients were treated before escalation to 1500 mg/m2/day, then three additional patients will be accrued. If no more than one of the six patients at the 800 mg/m2/day dose level experiences a DLT, then that dose level will be confirmed as the MTD.
Once the phase 1 portion of the study is completed, accrual to the phase 2 portion will begin. Patients treated at the MTD during the phase 1 portion will be included in the phase 2 component and will be evaluated for response and secondary end points.
The total study duration is 29 weeks, which includes a 2-week screening phase, a 23-week dosing phase, and a 4-week follow-up phase that begins after the last dose of ON 01910.Na. Patients will be assessed for response and will undergo follow up.
Patients who drop out for any reason will not be replaced. Patients who achieve a complete or partial response or stabilization of their disease by week 25 are eligible to receive an additional 24 weeks of ON 01910.Na at the same dose they received during the first 24 weeks of treatment(800 or 1500 mg/m2/day IVCI for 5 days Q2W).
- Conditions
- Myelodysplastic Syndrome
- Being tested
- ON 01910.Na Concentrate
- Keywords
- Myelodysplastic, IPSS Intermediate 1, IPSS Intermediate 2, IPSS High risk
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ON 01910.Na ConcentrateDrug
5-day continuous intravenous dosing of ON 01910.Na given every 2 weeks (1 cycle) at a dose of 800 mg/m2/day or 1500mg/m2/day for up to 24 cycles.
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (in Phase 1)
Measured: 1 month
Response according to International Working Group criteria (in Phase 2)
Measured: 2 to 3 months
Secondary outcomes (6)
Response time
Measured: 2 - 6 months
IPSS score
Measured: 2 to 6 months
Neutrophil response
Measured: 2 to 6 months
Platelet response
Measured: 2 to 6 months
Erythroid response
Measured: 2 to 6 months
Overall survival
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionJun 2010 (estimated)
- Study completionSep 2010 (estimated)
Why it stopped: Mutual decision by site and sponsor because of difficulty recruiting Patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Myelodysplastic SyndromeStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Traws Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Virginia Klimek, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00867061
- Sponsor's protocol ID
- Onconova 04-11
- Status last verified
- Jun 2017
- First submitted
- 19 Mar 2009
- Last updated
- 23 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Jimeno A, Chan A, Cusatis G, Zhang X, Wheelhouse J, Solomon A, Chan F, Zhao M, Cosenza SC, Ramana Reddy MV, Rudek MA, Kulesza P, Donehower RC, Reddy EP, Hidalgo M. Evaluation of the novel mitotic modulator ON 01910.Na in pancreatic cancer and preclinical development of an ex vivo predictive assay. Oncogene. 2009 Jan 29;28(4):610-8. doi: 10.1038/onc.2008.424. Epub 2008 Nov 24.
PubMed 19029951Cheson BD, Bennett JM, Kantarjian H, Pinto A, Schiffer CA, Nimer SD, Lowenberg B, Beran M, de Witte TM, Stone RM, Mittelman M, Sanz GF, Wijermans PW, Gore S, Greenberg PL; World Health Organization(WHO) international working group. Report of an international working group to standardize response criteria for myelodysplastic syndromes. Blood. 2000 Dec 1;96(12):3671-4.
PubMed 11090046Greenberg P, Cox C, LeBeau MM, Fenaux P, Morel P, Sanz G, Sanz M, Vallespi T, Hamblin T, Oscier D, Ohyashiki K, Toyama K, Aul C, Mufti G, Bennett J. International scoring system for evaluating prognosis in myelodysplastic syndromes. Blood. 1997 Mar 15;89(6):2079-88.
PubMed 9058730Aarthi Shenoy, Loretta Pfannes, Francois Wilhelm, Manoj Maniar, Neal Young, and Elaine M Sloand Suppression of Cyclin D 1 (CD1) by ON 01910.Na Is Associated with Decreased Survival or Trisomy 8 Myelodysplastic Bone Marrow: A Potential Targetted Therapy for Trisomy 8 MDS. Blood (ASH Annual Meeting Abstracts), Nov 2008; 112: 1651.
Elaine M. Sloand, Loretta Pfannes, Ramana Reddy, Premkumar Reddy, Jerome S. Groopman, and Neal S. Young Suppression of Cyclin D1 by ON 01910.Na Is Associated with Decreased Survival of Trisomy 8 Myelodyplastic Bone Marrow Progenitors: A Potential Targetted Therapy. Blood (ASH Annual Meeting Abstracts), Nov 2007; 110: 822.
Garcia-Manero G, Fenaux P. Comprehensive Analysis of Safety: Rigosertib in 557 Patients with Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML). Blood Dec 2016, 128 (22) 2011; ASH 2016.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Single-Arm Study To Assess The Efficacy and Safety Of 5-day Continuous Intravenous Dosing Of ON 01910.Na Administered Every 2 Weeks in Patients With Intermediate-1, Intermediate-2, or High Risk Myelodysplastic Syndrome (MDS)
- ClinicalTrials.gov ID
- NCT00867061
- Acronym / sponsor ID
- Onconova 04-11
- Conditions
- Myelodysplastic Syndrome
- Keywords
- Myelodysplastic, IPSS Intermediate 1, IPSS Intermediate 2, IPSS High risk
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Mutual decision by site and sponsor because of difficulty recruiting Patients.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Traws Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 23 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For MDS patients who have not responded to or have progressed after an initial response to DNA methyltransferase inhibitors (DNMTI) and are not stem cell transplant candidates, therapeutic options are limited. Participation in clinical trials such as this one may be considered. The specific objectives of this trial are to find out which dose of ON 01910.Na can be safety given to MDS patients and then find out if this dose of drug has any beneficial effects on the patients' disease. ON 01910.Na is a new, experimental drug; the reason for doing this trial is based on the anti-cancer activity of ON 01910.Na that has been observed in laboratory experiments and in early clinical trials.
Detailed description
This is a single center, open label, phase 1/2 study in which two to thirty three patients with Intermediate-1, Intermediate-2, or High risk MDS will receive ON 01910.Na as a intravenous continuous infusion (IVCI) over 24 hours for 5 consecutive days every 2 weeks.
In the phase 1 component of this trial the maximum tolerated dose of ON1910.Na in patients with Intermediate-1, Intermediate-2 or High Risk myelodysplastic syndromes will be determined. A standard "3+3" dose escalation scheme will be followed with up to six patients treated at the 800 mg/m2/day dose level. Patients will be observed for 2 cycles before dose escalation occurs. If none of the initial three patients in the 800 mg/m2/day cohort experience dose-limiting toxicity (DLT), during the first two cycles, then a new cohort of three patients will be treated at the 1500 mg/m2/day dose level. If none of the initial three patients in the 1500 mg/m2/day cohort experience DLT during the first two cycles, three additional patients will be treated at the 1500 mg/m2/day level. If no more than one of the six patients at the 1500 mg/m2/day dose level experiences a DLT, then that dose level will be confirmed as the MTD and no further dose escalation will occur.
If one of the three patients in the 800 mg/m2/day cohort experiences DLT during the first two cycles, then up to three additional patients will be treated at the same dose level. Escalation to 1500 mg/m2/day will proceed if only one of the six patients experiences DLT at the 800 mg/m2/day dose level. If two or more patients in the 800 mg/m2/day cohort experience DLT during the first two cycles, then the maximum tolerated dose (MTD) will have been exceeded, no further dose escalation will occur, and a full safety review will determine if further enrollment of patients will proceed.
If the 800 mg/m2/day dose level is under consideration as the MTD (i.e. if ≥ 2 patients experience DLT at the 1500 mg/m2/day dose level), and only three patients were treated before escalation to 1500 mg/m2/day, then three additional patients will be accrued. If no more than one of the six patients at the 800 mg/m2/day dose level experiences a DLT, then that dose level will be confirmed as the MTD.
Once the phase 1 portion of the study is completed, accrual to the phase 2 portion will begin. Patients treated at the MTD during the phase 1 portion will be included in the phase 2 component and will be evaluated for response and secondary end points.
The total study duration is 29 weeks, which includes a 2-week screening phase, a 23-week dosing phase, and a 4-week follow-up phase that begins after the last dose of ON 01910.Na. Patients will be assessed for response and will undergo follow up.
Patients who drop out for any reason will not be replaced. Patients who achieve a complete or partial response or stabilization of their disease by week 25 are eligible to receive an additional 24 weeks of ON 01910.Na at the same dose they received during the first 24 weeks of treatment(800 or 1500 mg/m2/day IVCI for 5 days Q2W).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of MDS confirmed within 4 weeks prior to study entry according to the World Health Organization (WHO) Criteria or the French-American-British (FAB) Classification.
- IPSS score of at least 0.5 (Intermediate-1, Intermediate-2 or High Risk MDS)
- Failure of, or insufficient response to 5-azacitidine or decitabine administered for 4 to 6 cycles.
- Failed to respond to, relapsed following, or opted not to participate in bone marrow transplantation.
- Off all other treatments for MDS, including filgrastim (G-CSF) and erythropoietin for at least 2 weeks, and off standard or investigational MDS therapies for four weeks.
Key exclusion criteria (18 listed)
- Anemia due to factors other than MDS (including hemolysis or gastrointestinal bleeding).
- Hypoplastic MDS (cellularity <10%).
- Any active malignancy within the past year except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast.
- History of HIV-1 seropositivity.
- Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia.
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 |
|---|---|---|
| ON 01910.Na Concentrate5-day continuous intravenous dosing of ON 01910.Na given every 2 weeks (1 cycle) at a dose of 800 mg/m2/day or 1500mg/m2/day for up to 24 cycles. | Drug | – |
Primary outcome
Maximum tolerated dose (in Phase 1)
Time frame: 1 month
Response according to International Working Group criteria (in Phase 2)
Time frame: 2 to 3 months
6 secondary outcomes
Response time
Time frame: 2 - 6 months
IPSS score
Time frame: 2 to 6 months
Neutrophil response
Time frame: 2 to 6 months
Platelet response
Time frame: 2 to 6 months
Erythroid response
Time frame: 2 to 6 months
Overall survival
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2017.
- Background: PubMed 19029951Jimeno A, Chan A, Cusatis G, Zhang X, Wheelhouse J, Solomon A, Chan F, Zhao M, Cosenza SC, Ramana Reddy MV, Rudek MA, Kulesza P, Donehower RC, Reddy EP, Hidalgo M. Evaluation of the novel mitotic modulator ON 01910.Na in pancreatic cancer and preclinical development of an ex vivo predictive assay. Oncogene. 2009 Jan 29;28(4):610-8. doi: 10.1038/onc.2008.424. Epub 2008 Nov 24.
- Background: PubMed 11090046Cheson BD, Bennett JM, Kantarjian H, Pinto A, Schiffer CA, Nimer SD, Lowenberg B, Beran M, de Witte TM, Stone RM, Mittelman M, Sanz GF, Wijermans PW, Gore S, Greenberg PL; World Health Organization(WHO) international working group. Report of an international working group to standardize response criteria for myelodysplastic syndromes. Blood. 2000 Dec 1;96(12):3671-4.
- Background: PubMed 9058730Greenberg P, Cox C, LeBeau MM, Fenaux P, Morel P, Sanz G, Sanz M, Vallespi T, Hamblin T, Oscier D, Ohyashiki K, Toyama K, Aul C, Mufti G, Bennett J. International scoring system for evaluating prognosis in myelodysplastic syndromes. Blood. 1997 Mar 15;89(6):2079-88.
- BackgroundAarthi Shenoy, Loretta Pfannes, Francois Wilhelm, Manoj Maniar, Neal Young, and Elaine M Sloand Suppression of Cyclin D 1 (CD1) by ON 01910.Na Is Associated with Decreased Survival or Trisomy 8 Myelodysplastic Bone Marrow: A Potential Targetted Therapy for Trisomy 8 MDS. Blood (ASH Annual Meeting Abstracts), Nov 2008; 112: 1651.
- BackgroundElaine M. Sloand, Loretta Pfannes, Ramana Reddy, Premkumar Reddy, Jerome S. Groopman, and Neal S. Young Suppression of Cyclin D1 by ON 01910.Na Is Associated with Decreased Survival of Trisomy 8 Myelodyplastic Bone Marrow Progenitors: A Potential Targetted Therapy. Blood (ASH Annual Meeting Abstracts), Nov 2007; 110: 822.
- Results publicationGarcia-Manero G, Fenaux P. Comprehensive Analysis of Safety: Rigosertib in 557 Patients with Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML). Blood Dec 2016, 128 (22) 2011; ASH 2016.
- Website of trial study center. Provides cancer care information to healthcare professionals, researchers, patients, family members, and the public.Link 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.
Virginia Klimek, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ON 01910.Na Concentrate in people with Myelodysplastic Syndrome, run by Traws Pharma, Inc. at 1 site in United States.
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 10 inclusion and 18 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: withdrawn, as of the sponsor's last update on 23 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Maximum tolerated dose (in Phase 1) (time frame: 1 month). 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?
On the ClinicalTrials.gov record for NCT00867061, which also lists 6 linked publications.
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 23 Jun 2017.