Solid TumorsPhase 1NCT02216669
Trial to Determine Optimal Phase II Dose of the Oral Dual CAIX Inhibitor/ Radiosensitizer
A Phase 1 study testing DTP348 in people with Solid Tumors and Head and Neck Neoplasms, run by Maastricht Radiation Oncology at 1 site in Netherlands.
Trial summary
This is a Phase I multicenter, open-label, dose-escalation study of DTP348. DTP 348 is an oral dual drug with two mechanisms of action: 1. carbonic anhydrase IX inhibitor which acidifies the intracellular pH through the sulfamide components 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Head and Neck Neoplasms
- What is being tested?
- DTP348
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2017to Jul 2017
- Phase
- Phase 1
- 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
- Patients with histologically or cytologically confirmed solid malignancy that is metastatic or unresectable and for which standard curative measures or other therapy that may provide clinical benefit do not exist or are no longer effective.
- Age 18 year or older
- Performance status, WHO = 0 - 2
- Subject must have adequate bone marrow, renal and hepatic function per local laboratory reference rage as follows:
- Bone marrow: absolute neutrophil count (ANC) >/= 1,500/ul; platelets >/= 100,000/mm3 (independent of platelet transfusion, within 3 months prior to starting study drug); haemoglobin >/= 9.0 g/dL
- Renal function: serum creatinine </= 2.0 mg/dL or calculated creatinine clearance >/= 50 mL/min
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- Hepatic function and enzymes: AST and ALT </= 2.5 x the upper limit of normal (ULN) of institution's normal range. Bilirubin </=1.5 x INL.
- Subjects with liver metastases may have an AST and ALT of </= 5.0 x ULN
- Measurable disease (RECIST, version 1.1)
- Subjects with known brain metastases must have clinically controlled neurologic symptoms, defined as surgical excision and or radiation therapy followed by 21 days of stable neurologic function and no evidence of CNS disease progression as determined by comparing a computed tomography (CT) scan or magnetic resonance imaging (MRI) scan performed during screening to a prior scan performed at least 4 weeks earlier and provided that the subject is asymptomatic, has no evidence of cavitation or haemorrhage and is on a stable dose of dexamethasone.
- Females must have negative results for pregnancy tests performed:
- At screening on a serum sample obtained within 7 days prior to initial study drug administration, and Prior to dosing on a urine pregnancy test will be obtained prior to study drug administration (cycle 1, day 1).
- No breast feeding.
- If female, subject must be either postmenopausal for at least 2 years, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing at least one of the following methods of birth control:
- Total abstinence from sexual intercourse as the preferred life style of the subject, periodic abstinence is not acceptable; Vasectomized partner; Hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to study drug administration (if the subject is currently using a hormonal contraceptive, she should also use a barrier method during the study and for 1 months after study completion); Intrauterine device (IUD); Double barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or creams);
- If male, subject must be surgically sterile or practicing at least 1 of the following methods of contraception and refrain from sperm donation, from initial drug administration until 90 days after the last dose of study drug: Partner(s) using an IUD; Partner(s) using hormonal contraceptives (oral, vaginal, parenteral or transdermal); Subject and/or partner(s) using double-barrier method (condoms, contraceptive sponge, diaphragm, or vaginal ring with spermicidal jellies or creams).
- Total abstinence from sexual intercourse as the preferred life style of the subject; periodic abstinence is not acceptable.
- Ability to swallow and take oral medication. Patients that are dependent on a feeding tube can only be included in the study when entered in the last cohort, in which the PK of crushed study medication is the object of study.
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Willing and able to undergo blood sampling for pharmacokinetics
- Must voluntarily sign and date each informed consent, approved by an independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
Who cannot join
- If the subject has clinically significant and uncontrolled major medical condition(s) including but not limited to:
- Uncontrolled seizure disorder, including focal or generalised seizure within the last 12 months; Uncontrolled nausea/vomiting/diarrhea; Active uncontrolled infection, including HIV and hepatitis (HBV, HCV) Symptomatic congestive heart failure, irreversible cardiac arrhythmias, acute or subacute coronary syndromes within the last year.
- Psychiatric illness/social situation that would limit compliance with study requirements Any medical condition, with the opinion of the study investigator, places the subject at an unacceptably high risk for toxicities.
- Female subject is pregnant or breastfeeding.
- Subject has received any of the following anti-cancer therapies 21 days prior to the first dose of study drug:
- Chemotherapy, immunotherapy, radiotherapy.
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- Any investigational therapy, including targeted small molecule agents. With the following exceptions:
- Hormonal anticancer therapy must be stopped 7 days before starting day 1 of cycle 1 (C1D1)
- Hormones for hypothyroidism, estrogen replacement therapy (ERT) or agonists required or suppress serum testosterone or estrogen levels (e.g. LHRH, GnRH, etc) for subjects with prostate, breast and ovarian cancer if on a stable dose for 21 days prior to the first dose of study drug.
- Subject has received a biological agent for anti-neoplastic intent within 30 days prior to the first dose of study drug.
- Subject who requires parenteral nutrition, tube feeding or has evidence of partial bowel obstruction or perforation within 28 days prior to study drug administration.
- The subject has had another active malignancy within the past 3 years except for any cancer in situ that the Principal Investigator considers to be cured.
- In the opinion of the investigator, the subject is an unsuitable candidate to receive DTP348.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Trial to Determine Optimal Phase II Dose of the Oral Dual CAIX Inhibitor/ Radiosensitizer
This is a Phase I multicenter, open-label, dose-escalation study of DTP348. DTP 348 is an oral dual drug with two mechanisms of action:
- carbonic anhydrase IX inhibitor which acidifies the intracellular pH through the sulfamide components
- radio sensitizer of hypoxic cells through its 5-nitroimidazole moiety
Read more
The study will be conducted in 2 parts. The phase I trials will be on the standard 3+3 design first as single agent then combined with radiotherapy:
- A single agent dose-escalation phase in patients with solid tumours.
- A dose-escalation phase in patients with HNSCC in combination with radiotherapy
The main objective is to determine the recommended phase II dose of DTP348 in combination with radiotherapy
Read the detailed description
In the single agent Phase I dose-escalation phase patients will be enrolled and assigned to a dose level cohort. The starting dose will be 750 mg/m2, which equals to 1/10 of the human equivalent dose of the LD10 of DTP348 in mice.
A "3+3" dose-escalation design will be used. The study will investigate sequential cohorts consisting of 3-6 patients to be enrolled and treated at the applicable dose level. Planned dose levels for subsequent cohorts are 1000, 1250 mg/m2 and steps of 250 mg/m2 thereafter. There will be no intra-patient dose escalation. The treatment cycle in the dose-escalation part of the study will consist of 7 weeks (reflecting the typical duration of the course of radiotherapy). Patients will receive a continuous oral dose of DTP348 for 7 days per week. Food intake is not allowed one hour before and after the intake of the study drug. After the cycle of treatment, the patient will be followed until disease progression.
Blood samples for pharmacokinetic properties (PK) will be obtained on day 1 during the first 8 hours after oral administration and then daily on day 2, 3, 4 and 5, before the administration of the daily dosage. A patient will stay on treatment until disease progression, unacceptable toxicity, or discontinuation for any other reason. The dose limiting toxicity (DLT) observation period for each dose level will be day 1 until the end of week 7. Patients who do not complete the DLT observation period for other reasons than a DLT will be replaced.
Toxicity that can be expected from DTP348 is related to the nitro-imidazole compound and includes nausea, vomiting flushing, dizziness, skin rash, and neurotoxicity. Related to the sulfamide component in the study drug, the side-effects may include nausea and vomiting. In the experimental mice study, no toxicity was observed using a dose of 10 mg/kg i.v. 3 and up to 400 mg/kg per os, which corresponds to the Human Equivalent Dose (HED) of 1.2 g/m2 of nimorazole. Once the Maximum Tolerated Dose (MTD) of DTP348 has been established, 3 additional patients will be included in that dose-level. These patients will receive crushed tablets and undergo blood sampling for PK to investigate whether the administration of crushed tablets affects uptake and plasma levels of the study drug. This group of patients is added because of the frequent occurrence of swallowing problems in the HNSCC patient population and the use of tube feeding with the need of crushing tablets.
Once the MTD of DTP348 as single agent has been determined, the study will continue to the combination phase: In the DTP348 in combination with radiotherapy dose-escalation phase, again a 3+3 dose-escalation design will be used. The starting dose of DT348 will be the MTD minus two dose levels. DTP348 will be given continuously 7 days a week, starting 2 weeks before and during the whole course of radiation until and including the last day. The rationale to start the study drug 2 weeks before the start of radiotherapy is to have a similar design as in the phase II trial which will be performed following this study. The drug will be given orally 1-2 hours before the daily delivery of radiotherapy. Food intake is not allowed one hour before and after the intake of the study drug. The dose limiting toxicity (DLT) observation period for each dose level will be from day 1 of combined therapy until 4 weeks after the end of therapy. Patients who do not complete the DLT observation period for other reasons than a DLT will be replaced.
The radiation treatment in the DTP348 in combination with radiotherapy dose-escalation phase will be either conventional standard fractionated radiotherapy to a total dose of 70 Gy in 35 fractions over 7 weeks with a concomitant boost technique, 5 fractions a week or accelerated radiotherapy delivering a total dose to 68-70 Gy in a shortened overall treatment time (5.5 - 6 weeks). The 95% isodose of the prescribed dose should encompass at least 99% of the planning target and homogeneity will be according to ICRU guidelines. There is no restriction of the treatment techniques that may be used: multiple static conformal or intensity modulated beams, intensity modulated arc treatments, or robotic, non-isocentric treatments. Dummy run on virtual patients will need to be performed before inclusion. Subsequently, patients are allowed to be included in the trial.
- Conditions
- Solid Tumors, Head and Neck Neoplasms
- Being tested
- DTP348
- Keywords
- Solid tumors, Head and Neck Neoplasms
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTP348Drug
Also called 2-(2-methyl-5-nitro-1H-imidazol-1-yl)ethylsulfamide
Patients will receive a continuous oral dose of DTP348 for 7 days per week for 7 weeks
| Study group | Role | What they receive |
|---|---|---|
| DTP348 | Experimental | Patients will receive a continuous oral dose of DTP348 for 7 days per week for 7 weeks Receives: Drug: DTP348 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum-tolerated dose (MTD) of DTP348 as single agent
To assess the safety and tolerability of DTP348 when administered orally as single agent in patients with advanced solid tumours in order to determine the Maximum Tolerated Dose (MTD) in relation with the occurrence of a Dose Limiting Toxicity (DLT).
Measured: 3 months
The maximum-tolerated dose (MTD) regimen of DTP348 as single agent in combination with radiotherapy
To assess the safety and tolerability of DTP348 when administered orally in combination with radiotherapy in patients with HNSCC and to determine the Recommended Phase II Dose (RP2D) of this treatment combination.
Measured: 3 months
Secondary outcomes (3)
Plasma concentration of DTP348
To characterise the Pharmacokinetic (PK) properties of DTP348 after oral administration as single agent
Measured: 3 months
Response rate according to RECIST, version 1.1, DTP348 monotherapy
To evaluate the preliminary efficacy of DTP348 monotherapy in terms of anti-tumour activity
Measured: 3 months
Response rate according to RECIST version 1.1, DTP348 in combination of radiotherapy
To evaluate the preliminary efficacy of DTP348 in combination with radiotherapy in terms of anti-tumour activity in patients with HNSCC.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startMar 2017 (estimated)
- Primary completionJun 2017 (estimated)
- Study completionJul 2017 (estimated)
Why it stopped: No financial agreement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank Hoebers, Dr., Principal investigator, Maastro Clinic, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216669
- Sponsor's protocol ID
- 08-2014
- Status last verified
- Mar 2017
- First submitted
- 8 Aug 2014
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial to Determine Optimal Phase II Dose of the Oral Dual CAIX Inhibitor/ Radiosensitizer
- ClinicalTrials.gov ID
- NCT02216669
- Acronym / sponsor ID
- 08-2014
- Conditions
- Solid Tumors, Head and Neck Neoplasms
- Keywords
- Solid tumors, Head and Neck Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No financial agreement
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Study start
- Mar 2017 (estimated)
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 15 Aug 2014 (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.
This is a Phase I multicenter, open-label, dose-escalation study of DTP348. DTP 348 is an oral dual drug with two mechanisms of action:
- carbonic anhydrase IX inhibitor which acidifies the intracellular pH through the sulfamide components
- radio sensitizer of hypoxic cells through its 5-nitroimidazole moiety
The study will be conducted in 2 parts. The phase I trials will be on the standard 3+3 design first as single agent then combined with radiotherapy:
- A single agent dose-escalation phase in patients with solid tumours.
- A dose-escalation phase in patients with HNSCC in combination with radiotherapy
The main objective is to determine the recommended phase II dose of DTP348 in combination with radiotherapy
Detailed description
In the single agent Phase I dose-escalation phase patients will be enrolled and assigned to a dose level cohort. The starting dose will be 750 mg/m2, which equals to 1/10 of the human equivalent dose of the LD10 of DTP348 in mice.
A "3+3" dose-escalation design will be used. The study will investigate sequential cohorts consisting of 3-6 patients to be enrolled and treated at the applicable dose level. Planned dose levels for subsequent cohorts are 1000, 1250 mg/m2 and steps of 250 mg/m2 thereafter. There will be no intra-patient dose escalation. The treatment cycle in the dose-escalation part of the study will consist of 7 weeks (reflecting the typical duration of the course of radiotherapy). Patients will receive a continuous oral dose of DTP348 for 7 days per week. Food intake is not allowed one hour before and after the intake of the study drug. After the cycle of treatment, the patient will be followed until disease progression.
Blood samples for pharmacokinetic properties (PK) will be obtained on day 1 during the first 8 hours after oral administration and then daily on day 2, 3, 4 and 5, before the administration of the daily dosage. A patient will stay on treatment until disease progression, unacceptable toxicity, or discontinuation for any other reason. The dose limiting toxicity (DLT) observation period for each dose level will be day 1 until the end of week 7. Patients who do not complete the DLT observation period for other reasons than a DLT will be replaced.
Toxicity that can be expected from DTP348 is related to the nitro-imidazole compound and includes nausea, vomiting flushing, dizziness, skin rash, and neurotoxicity. Related to the sulfamide component in the study drug, the side-effects may include nausea and vomiting. In the experimental mice study, no toxicity was observed using a dose of 10 mg/kg i.v. 3 and up to 400 mg/kg per os, which corresponds to the Human Equivalent Dose (HED) of 1.2 g/m2 of nimorazole. Once the Maximum Tolerated Dose (MTD) of DTP348 has been established, 3 additional patients will be included in that dose-level. These patients will receive crushed tablets and undergo blood sampling for PK to investigate whether the administration of crushed tablets affects uptake and plasma levels of the study drug. This group of patients is added because of the frequent occurrence of swallowing problems in the HNSCC patient population and the use of tube feeding with the need of crushing tablets.
Once the MTD of DTP348 as single agent has been determined, the study will continue to the combination phase: In the DTP348 in combination with radiotherapy dose-escalation phase, again a 3+3 dose-escalation design will be used. The starting dose of DT348 will be the MTD minus two dose levels. DTP348 will be given continuously 7 days a week, starting 2 weeks before and during the whole course of radiation until and including the last day. The rationale to start the study drug 2 weeks before the start of radiotherapy is to have a similar design as in the phase II trial which will be performed following this study. The drug will be given orally 1-2 hours before the daily delivery of radiotherapy. Food intake is not allowed one hour before and after the intake of the study drug. The dose limiting toxicity (DLT) observation period for each dose level will be from day 1 of combined therapy until 4 weeks after the end of therapy. Patients who do not complete the DLT observation period for other reasons than a DLT will be replaced.
The radiation treatment in the DTP348 in combination with radiotherapy dose-escalation phase will be either conventional standard fractionated radiotherapy to a total dose of 70 Gy in 35 fractions over 7 weeks with a concomitant boost technique, 5 fractions a week or accelerated radiotherapy delivering a total dose to 68-70 Gy in a shortened overall treatment time (5.5 - 6 weeks). The 95% isodose of the prescribed dose should encompass at least 99% of the planning target and homogeneity will be according to ICRU guidelines. There is no restriction of the treatment techniques that may be used: multiple static conformal or intensity modulated beams, intensity modulated arc treatments, or robotic, non-isocentric treatments. Dummy run on virtual patients will need to be performed before inclusion. Subsequently, patients are allowed to be included in the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DTP348 | Experimental | Drug: DTP348Patients will receive a continuous oral dose of DTP348 for 7 days per week for 7 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Patients with histologically or cytologically confirmed solid malignancy that is metastatic or unresectable and for which standard curative measures or other therapy that may provide clinical benefit do not exist or are no longer effective.
- Age 18 year or older
- Performance status, WHO = 0 - 2
- Subject must have adequate bone marrow, renal and hepatic function per local laboratory reference rage as follows:
- Bone marrow: absolute neutrophil count (ANC) >/= 1,500/ul; platelets >/= 100,000/mm3 (independent of platelet transfusion, within 3 months prior to starting study drug); haemoglobin >/= 9.0 g/dL
Key exclusion criteria (13 listed)
- If the subject has clinically significant and uncontrolled major medical condition(s) including but not limited to:
- Uncontrolled seizure disorder, including focal or generalised seizure within the last 12 months; Uncontrolled nausea/vomiting/diarrhea; Active uncontrolled infection, including HIV and hepatitis (HBV, HCV) Symptomatic congestive heart failure, irreversible cardiac arrhythmias, acute or subacute coronary syndromes within the last year.
- Psychiatric illness/social situation that would limit compliance with study requirements Any medical condition, with the opinion of the study investigator, places the subject at an unacceptably high risk for toxicities.
- Female subject is pregnant or breastfeeding.
- Subject has received any of the following anti-cancer therapies 21 days prior to the first dose of study drug:
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 |
|---|---|---|
| DTP348Also: 2-(2-methyl-5-nitro-1H-imidazol-1-yl)ethylsulfamidePatients will receive a continuous oral dose of DTP348 for 7 days per week for 7 weeks | Drug | DTP348 |
Primary outcome
The maximum-tolerated dose (MTD) of DTP348 as single agent
Time frame: 3 months
To assess the safety and tolerability of DTP348 when administered orally as single agent in patients with advanced solid tumours in order to determine the Maximum Tolerated Dose (MTD) in relation with the occurrence of a Dose Limiting Toxicity (DLT).
The maximum-tolerated dose (MTD) regimen of DTP348 as single agent in combination with radiotherapy
Time frame: 3 months
To assess the safety and tolerability of DTP348 when administered orally in combination with radiotherapy in patients with HNSCC and to determine the Recommended Phase II Dose (RP2D) of this treatment combination.
3 secondary outcomes
Plasma concentration of DTP348
Time frame: 3 months
Response rate according to RECIST, version 1.1, DTP348 monotherapy
Time frame: 3 months
Response rate according to RECIST version 1.1, DTP348 in combination of radiotherapy
Time frame: 3 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 3 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Frank Hoebers, Dr. principal investigator
Maastro Clinic, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DTP348 in people with Solid Tumors and Head and Neck Neoplasms, run by Maastricht Radiation Oncology at 1 site in Netherlands.
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 21 inclusion and 13 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 3 Mar 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 Netherlands. 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 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.
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?
The maximum-tolerated dose (MTD) of DTP348 as single agent (time frame: 3 months). 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 3 Mar 2017.