MalariaPhase 1NCT02661373

First-in-Human Study of an Oral Plasmodium Falciparum Plasma Membrane Protein Inhibitor

A Phase 1 study testing SJ733 and Cobicistat in people with Malaria, run by St. Jude Children's Research Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Malaria
What is being tested?: SJ733 and Cobicistat
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 1 siteUnited States
Study dates: 1 Mar 2016to 9 Mar 2018
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 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy adult (as certified by comprehensive medical assessment including detailed history and complete physical examination), male or female, aged 18 to 55 years of age (inclusive) at screening
At least 50 kg in weight and body mass index (BMI) between 18 and 34 kg/m^2
Able and willing to provide informed consent and to be available for follow-up for the planned duration of the study
If female, then not of child bearing potential (i.e. permanently sterilized hysterectomy or bilateral oophorectomy at least 6 months before screening; proper documentation required] and/or post-menopausal defined as 12 months with no menses without an alternative cause and with an estradiol level of < 30 pg/mL and follicle-stimulating hormone level of > 40 IU/L at screening)
Sexually active males must agree to be abstinent or use condoms for the duration of the study.
Screening laboratories (hematology, chemistries, venous methemoglobin level specified in schedule of evaluations) within normal institutional range or if outside the range, not clinically significant in the opinion of the investigator.

Show all 14Show fewer

Inclusion Criteria for Participants in Single-dose Cohort Only::
Agrees not to receive any vaccination within 7 days prior to Day 0 and through Day 7.
Agrees not to use nonprescription drugs, including vitamins, antacids, and herbal and dietary supplements within 7 days prior to Day 0 and through Day 7. Acetaminophen may be used at doses of ≤ 1 g/day, and ibuprofen may be used at doses of ≤ 1.2 g/day.
Agrees not to use nicotine containing products from screening through Day 7.
Agrees not to consume alcohol for the 24 hours prior to Day 0 and through Day 7.
Agrees not to eat pomegranate, grapefruit or other citrus fruits or drink their juices within 7 days prior to Day 0 and through Day 7.
Agrees to limit caffeine to no more than 200 mg on Day 0.
Agrees not to eat or drink (except water) for 10 hours before the Day 0 visit and have no water for the hour prior to dosing.

Who cannot join

Presence of a significant medical or psychiatric condition that in the opinion of the investigator precludes participation in the study.
Clinically significant abnormalities on physical examination that, in the opinion of the investigator, would preclude entry into the study.
History of having a significant illness within the 2 weeks prior to screening visit. Participants can screen after illness is resolved for two weeks.
History of clinically significant electrocardiogram abnormalities or clinically significant abnormalities from the screening electrocardiogram.
G6PD deficiency
History of hemolytic anemia or methemoglobinemia

Show all 28Show fewer

History of severe drug hypersensitivity including a severe allergic reaction, anaphylaxis or convulsions following any medication, vaccination or infusion.
History of drug or alcohol abuse in the 12 months prior to screening or evidence at screening visit
Use of nicotine containing products within 30 days prior to screening
Positive blood test for HBsAg, HCV, or HIV-1
Participation in a clinical study of another investigational product within 30 days prior to study enrollment, or planning to begin such participation during the study.
Employment under the direct supervision of the investigators or study staff.
Receipt of any vaccination within 7 days of dosing.
Febrile illness within 48 hours of dosing
Use of any prescription medication within 14 days prior to study drug administration.
Use of nonprescription drugs, including vitamins, antacids, and herbal and dietary supplements within 7 days prior to study drug administration. Acetaminophen may be used at doses of ≤ 1 g/day, and ibuprofen may be used at doses of ≤ 1.2 g/day.
Consumption of pomegranate, grapefruit or other citrus fruits or their juices within 7 days prior to study drug administration.
Use of nicotine containing products from screening to study drug administration.
Consumption of alcohol within 24 hours prior to study drug administration.
Inclusion Criteria For participants in multi-dose cohort only:
Agrees not to receive any vaccination within 7 days prior to Day 1 and through Day 10.
Agrees not to use nonprescription drugs, including vitamins, antacids, and herbal and dietary supplements within 7 days prior to Day 1 and through Day 10. Acetaminophen may be used at doses of ≤ 1 g/day, and ibuprofen may be used at doses of ≤ 1.2 g/day.
Agrees not to use nicotine containing products from screening through Day 10.
Agrees not to consume alcohol for the 24 hours prior to Day 1 and through Day 10.
Agrees not to eat pomegranate, grapefruit or other citrus fruits or drink their juices within 7 days prior to Day 1 and through Day 10.
Agrees to limit caffeine to no more than 200 mg on Days 1, 2, and 3.
Agrees not to eat or drink (except water) for 10 hours before the Days 1, 2, and 3 visits and have no water for the hour prior to dosing on each of those days.
Note: As with the single dose study, sexually active must agree to be abstinent or use condoms for the duration of the study (through the Day 14 visit).

Trial locations and contacts

1 site in 1 country.

United States1 site

St. Jude Children's Research Hospital
Memphis, Tennessee, 38105

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About this study

Official title: Phase 1a, First-In-Human, Dose-Escalation Study of (+)-SJ000557733 (SJ733), an Oral, Novel Inhibitor of Plasmodium Falciparum Plasma Membrane Protein PfATP4

Malaria is an infectious disease caused by a parasite that is passed to humans when an infected mosquito bites a person. About 3.4 billion people live in areas of the world where malaria is regularly found. In many countries, malaria is one of the leading causes of illness and death. Despite this, there are a limited number of drugs, called antimalarials, that can be used to treat malaria and increasing reports of resistance to existing antimalarials.

The purpose of this research study is to test a new experimental antimalarial drug called SJ733 to first assess its safety, tolerability and blood levels in healthy adult volunteers.

Single-dose, multi-dose and boosted-dose cohorts (both single and multi-dose) will be studied. The pharmacoenhancer (booster), cobicistat, will be given in combination with SJ733 in the boosted dose-cohorts.

PRIMARY OBJECTIVES:

To assess the preliminary safety and tolerability of escalating doses of antimalarial SJ733 in healthy human volunteers.
To investigate the pharmacokinetic (PK) profile of escalating doses of antimalarial SJ733 and its metabolite in healthy human volunteers.
To identify a dose of SJ733 that can be tested in a separate Phase 1b human malaria challenge study.
To assess the preliminary safety and tolerability of SJ733 in healthy adult volunteers after multiple oral dosing.
To assess the pharmacokinetics of SJ733 and its metabolite SJ506 after multiple dosing of SJ733 in healthy adult volunteers.
To assess the preliminary safety and tolerability of escalating single oral doses of SJ733 in combination with cobicistat among healthy adult volunteers.
To assess the pharmacokinetics of SJ733 and its metabolite SJ506 after single oral doses of SJ733 in combination with cobicistat among healthy adult volunteers.
To assess the preliminary safety and tolerability of SJ733 in combination with cobicistat in healthy adult volunteers after multiple oral dosing.
To assess the pharmacokinetics of SJ733 and its metabolite SJ506 after multiple dosing of SJ733 in combination with cobicistat among healthy volunteers.

SECONDARY OBJECTIVE:

To assess the impact of food intake on the pharmacokinetic profile of antimalarial SJ733.

Read the detailed description

This is a single site, Phase 1a, first-in-human, oral, primarily single-dose, dose escalation study of (+)-SJ000557733 (SJ733) in healthy adult volunteers. SJ733, is an investigational oral anti-malarial agent is a novel inhibitor of Plasmodium falciparum plasma membrane protein (PfATP4). Subjects meeting eligibility criteria will be enrolled using a leap frog, fixed dose escalation design with an adaptive component where 6 subjects are enrolled per dose cohort.

Following successful completion of the safety and pharmacokinetic (PK) assessment resulting from the single-dose escalation portion of the study, a three-dose cohort study will be undertaken. It includes once per day oral dosing for 3 consecutive days. Both single and multi-dose cohorts of SJ733 in combination with cobicistat (boosted cohorts) will also be completed.

After the study results from the single-dose cohorts of SJ733 in combination with cobicistat (boosted cohorts) were reviewed, multi-dose cohorts of SJ733 in combination with cobicistat (boosted cohorts) were not conducted and Phase 2 study planning initiated.

Conditions: Malaria
Being tested: SJ733, Cobicistat
Keywords: Antimalarial, First-in-Human, Pharmacokinetic
Medical subject headings: Malaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SJ733Drug
Also called (+)-SJ000557733
SJ733 is an oral, novel inhibitor of Plasmodium Falciparum plasma membrane protein PFATP4. It will be administered as a single, multi, or boosted oral dose.
CobicistatDrug
Also called Tybost®
Commercially available cobicistat 150 mg tablets will be used. It will be administered as a single oral dose together with SJ733.

Study groups in NCT02661373
Study group	Role	What they receive
Treatment Arm	Experimental	Participants will receive SJ733, an investigational drug developed at St. Jude Children's Research Hospital, and cobicistat. Receives: Drug: SJ733; Drug: Cobicistat

What is being measured

The primary outcome is the main question the study is designed to answer.

Dose limiting toxicity (DLT)
Number of DLT events will be described at each study dose level. DLT is defined as possibly, probably, or definitely related Grade 4 event, possibly, probably or definitely related Grade 3 event, or possibly, probably, or definitely related Grade 2 methemoglobinemia or anemia (attributed to hemolysis) events.
Measured: From baseline up to minimum of 7 days post-dose
Maximum tolerated dose (MTD)
MTD is defined as the dose level prior to the dose cohort that 2 or more Grade 2 methemoglobinemia or anemia (attributed to hemolysis) OR any related Grade 3 OR any Grade 4, study drug adverse event (AE) occurred in.
Measured: 7 days after the last dose administration
Drug absorption
Drug absorption of SJ733 and its metabolite will be reported.
Measured: From baseline through 7 days post-dose
Drug clearance
Drug clearance of SJ733 and its metabolite will be reported.
Measured: From baseline through 7 days post-dose
Drug volume of distribution
Drug volume of distribution of SJ733 and its metabolite will be reported.
Measured: From baseline through 7 days post-dose
Area under the curve (AUC)
AUC of SJ733 and its metabolite will be reported.
Measured: From baseline through 7 days post-dose
Time above threshold concentration
Time above threshold concentration of SJ733 and its metabolite will be reported.
Measured: From baseline through 7 days post-dose
Maximum drug concentration (Cmax)
Cmax of SJ733 and its metabolite will be reported.
Measured: From baseline through 7 days post-dose
Dose level of SJ733
The dose chosen for the phase 1b trial will be no greater than the MTD and provide an exposure (AUC and time above threshold concentration) that equates (using applicable scaling) with those that provided maximum parasitological effect in the gold standard rodent model.
Measured: 14 days after the last dose administration

Secondary outcomes (6)

Drug absorption in the fed cohort
Drug absorption of SJ733 and its metabolite in the fed cohort will be reported to assess the impact of food intake.
Measured: From baseline through 7 days post-dose
Drug clearance in the fed cohort
Drug clearance of SJ733 and its metabolite in the fed cohort will be reported to assess the impact of food intake.
Measured: From baseline through 7 days post-dose
Drug volume of distribution in the fed cohort
Drug volume of distribution of SJ733 and its metabolite in the fed cohort will be reported to assess the impact of food intake.
Measured: From baseline through 7 days post-dose
Area under the curve (AUC) in the fed cohort
AUC of SJ733 and its metabolite in the fed cohort will be reported to assess the impact of food intake.
Measured: From baseline through 7 days post-dose
Time above threshold concentration in the fed cohort
Time above threshold concentration SJ733 and its metabolite in the fed cohort will be reported to assess the impact of food intake.
Measured: From baseline through 7 days post-dose
Maximum drug concentration (Cmax) in the fed cohort
Drug absorption of SJ733 and its metabolite in the fed cohort will be reported to assess the impact of food intake.
Measured: From baseline through 7 days post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 20169 Mar 2018

First posted22 Jan 2016 (estimated)
Study start1 Mar 2016
Primary completion9 Mar 2018
Study completion9 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for MalariaStudies of the same condition, open and under way.
More trials run by St. Jude Children's Research HospitalThe 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 1
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02661373
Sponsor's protocol ID: BUZZOFF
Status last verified: Dec 2018
First submitted: 19 Jan 2016
Last updated: 2 Jan 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Gaur AH, Panetta JC, Smith AM, Dallas RH, Freeman BB 3rd, Stewart TB, Tang L, John E, Branum KC, Patel ND, Ost S, Heine RN, Richardson JL, Hammill JT, Bebrevska L, Gusovsky F, Maki N, Yanagi T, Flynn PM, McCarthy JS, Chalon S, Guy RK. Combining SJ733, an oral ATP4 inhibitor of Plasmodium falciparum, with the pharmacokinetic enhancer cobicistat: An innovative approach in antimalarial drug development. EBioMedicine. 2022 Jun;80:104065. doi: 10.1016/j.ebiom.2022.104065. Epub 2022 May 19.
PubMed 35598441
Gaur AH, McCarthy JS, Panetta JC, Dallas RH, Woodford J, Tang L, Smith AM, Stewart TB, Branum KC, Freeman BB 3rd, Patel ND, John E, Chalon S, Ost S, Heine RN, Richardson JL, Christensen R, Flynn PM, Van Gessel Y, Mitasev B, Mohrle JJ, Gusovsky F, Bebrevska L, Guy RK. Safety, tolerability, pharmacokinetics, and antimalarial efficacy of a novel Plasmodium falciparum ATP4 inhibitor SJ733: a first-in-human and induced blood-stage malaria phase 1a/b trial. Lancet Infect Dis. 2020 Aug;20(8):964-975. doi: 10.1016/S1473-3099(19)30611-5. Epub 2020 Apr 8.
PubMed 32275867

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1a, First-In-Human, Dose-Escalation Study of (+)-SJ000557733 (SJ733), an Oral, Novel Inhibitor of Plasmodium Falciparum Plasma Membrane Protein PfATP4
ClinicalTrials.gov ID: NCT02661373
Acronym / sponsor ID: BUZZOFF
Conditions: Malaria
Keywords: Antimalarial, First-in-Human, Pharmacokinetic
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: St. Jude Children's Research HospitalUniversity, hospital or other
Collaborators: Medicines for Malaria Venture, Eisai Inc., Global Health Innovative Technology Fund
Study start: 1 Mar 2016 (actual)
Primary completion: 9 Mar 2018 (actual)
Study completion: 9 Mar 2018 (actual)
First posted: 22 Jan 2016 (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.

The purpose of this research study is to test a new experimental antimalarial drug called SJ733 to first assess its safety, tolerability and blood levels in healthy adult volunteers.

PRIMARY OBJECTIVES:

To assess the preliminary safety and tolerability of escalating doses of antimalarial SJ733 in healthy human volunteers.
To investigate the pharmacokinetic (PK) profile of escalating doses of antimalarial SJ733 and its metabolite in healthy human volunteers.
To identify a dose of SJ733 that can be tested in a separate Phase 1b human malaria challenge study.
To assess the preliminary safety and tolerability of SJ733 in healthy adult volunteers after multiple oral dosing.
To assess the pharmacokinetics of SJ733 and its metabolite SJ506 after multiple dosing of SJ733 in healthy adult volunteers.
To assess the preliminary safety and tolerability of escalating single oral doses of SJ733 in combination with cobicistat among healthy adult volunteers.
To assess the pharmacokinetics of SJ733 and its metabolite SJ506 after single oral doses of SJ733 in combination with cobicistat among healthy adult volunteers.
To assess the preliminary safety and tolerability of SJ733 in combination with cobicistat in healthy adult volunteers after multiple oral dosing.
To assess the pharmacokinetics of SJ733 and its metabolite SJ506 after multiple dosing of SJ733 in combination with cobicistat among healthy volunteers.

SECONDARY OBJECTIVE:

To assess the impact of food intake on the pharmacokinetic profile of antimalarial SJ733.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment Arm	Experimental	Drug: SJ733, Drug: CobicistatParticipants will receive SJ733, an investigational drug developed at St. Jude Children's Research Hospital, and cobicistat.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (14 listed)

Healthy adult (as certified by comprehensive medical assessment including detailed history and complete physical examination), male or female, aged 18 to 55 years of age (inclusive) at screening
At least 50 kg in weight and body mass index (BMI) between 18 and 34 kg/m^2
Able and willing to provide informed consent and to be available for follow-up for the planned duration of the study
If female, then not of child bearing potential (i.e. permanently sterilized hysterectomy or bilateral oophorectomy at least 6 months before screening; proper documentation required] and/or post-menopausal defined as 12 months with no menses without an alternative cause and with an estradiol level of < 30 pg/mL and follicle-stimulating hormone level of > 40 IU/L at screening)
Sexually active males must agree to be abstinent or use condoms for the duration of the study.

Key exclusion criteria (28 listed)

Presence of a significant medical or psychiatric condition that in the opinion of the investigator precludes participation in the study.
Clinically significant abnormalities on physical examination that, in the opinion of the investigator, would preclude entry into the study.
History of having a significant illness within the 2 weeks prior to screening visit. Participants can screen after illness is resolved for two weeks.
History of clinically significant electrocardiogram abnormalities or clinically significant abnormalities from the screening electrocardiogram.
G6PD deficiency

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
SJ733Also: (+)-SJ000557733SJ733 is an oral, novel inhibitor of Plasmodium Falciparum plasma membrane protein PFATP4. It will be administered as a single, multi, or boosted oral dose.	Drug	Treatment Arm
CobicistatAlso: Tybost®Commercially available cobicistat 150 mg tablets will be used. It will be administered as a single oral dose together with SJ733.	Drug	Treatment Arm

Primary outcome

Dose limiting toxicity (DLT)
Time frame: From baseline up to minimum of 7 days post-dose
Number of DLT events will be described at each study dose level. DLT is defined as possibly, probably, or definitely related Grade 4 event, possibly, probably or definitely related Grade 3 event, or possibly, probably, or definitely related Grade 2 methemoglobinemia or anemia (attributed to hemolysis) events.
Maximum tolerated dose (MTD)
Time frame: 7 days after the last dose administration
MTD is defined as the dose level prior to the dose cohort that 2 or more Grade 2 methemoglobinemia or anemia (attributed to hemolysis) OR any related Grade 3 OR any Grade 4, study drug adverse event (AE) occurred in.
Drug absorption
Time frame: From baseline through 7 days post-dose
Drug absorption of SJ733 and its metabolite will be reported.
Drug clearance
Time frame: From baseline through 7 days post-dose
Drug clearance of SJ733 and its metabolite will be reported.
Drug volume of distribution
Time frame: From baseline through 7 days post-dose
Drug volume of distribution of SJ733 and its metabolite will be reported.
Area under the curve (AUC)
Time frame: From baseline through 7 days post-dose
AUC of SJ733 and its metabolite will be reported.
Time above threshold concentration
Time frame: From baseline through 7 days post-dose
Time above threshold concentration of SJ733 and its metabolite will be reported.
Maximum drug concentration (Cmax)
Time frame: From baseline through 7 days post-dose
Cmax of SJ733 and its metabolite will be reported.
Dose level of SJ733
Time frame: 14 days after the last dose administration
The dose chosen for the phase 1b trial will be no greater than the MTD and provide an exposure (AUC and time above threshold concentration) that equates (using applicable scaling) with those that provided maximum parasitological effect in the gold standard rodent model.

6 secondary outcomes

Drug absorption in the fed cohort
Time frame: From baseline through 7 days post-dose
Drug clearance in the fed cohort
Time frame: From baseline through 7 days post-dose
Drug volume of distribution in the fed cohort
Time frame: From baseline through 7 days post-dose
Area under the curve (AUC) in the fed cohort
Time frame: From baseline through 7 days post-dose
Time above threshold concentration in the fed cohort
Time frame: From baseline through 7 days post-dose
Maximum drug concentration (Cmax) in the fed cohort
Time frame: From baseline through 7 days post-dose

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2019.
Derived from this study: PubMed 35598441Gaur AH, Panetta JC, Smith AM, Dallas RH, Freeman BB 3rd, Stewart TB, Tang L, John E, Branum KC, Patel ND, Ost S, Heine RN, Richardson JL, Hammill JT, Bebrevska L, Gusovsky F, Maki N, Yanagi T, Flynn PM, McCarthy JS, Chalon S, Guy RK. Combining SJ733, an oral ATP4 inhibitor of Plasmodium falciparum, with the pharmacokinetic enhancer cobicistat: An innovative approach in antimalarial drug development. EBioMedicine. 2022 Jun;80:104065. doi: 10.1016/j.ebiom.2022.104065. Epub 2022 May 19.
Derived from this study: PubMed 32275867Gaur AH, McCarthy JS, Panetta JC, Dallas RH, Woodford J, Tang L, Smith AM, Stewart TB, Branum KC, Freeman BB 3rd, Patel ND, John E, Chalon S, Ost S, Heine RN, Richardson JL, Christensen R, Flynn PM, Van Gessel Y, Mitasev B, Mohrle JJ, Gusovsky F, Bebrevska L, Guy RK. Safety, tolerability, pharmacokinetics, and antimalarial efficacy of a novel Plasmodium falciparum ATP4 inhibitor SJ733: a first-in-human and induced blood-stage malaria phase 1a/b trial. Lancet Infect Dis. 2020 Aug;20(8):964-975. doi: 10.1016/S1473-3099(19)30611-5. Epub 2020 Apr 8.
St. Jude Children's Research HospitalLink provided by the sponsor.
Clinical Trials Open at St. JudeLink 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.

Aditya H. Gaur, MD principal investigator

St. Jude Children's Research Hospital

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 SJ733 and Cobicistat in people with Malaria, run by St. Jude Children's Research Hospital 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 14 inclusion and 28 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 2 Jan 2019. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Dose limiting toxicity (DLT) (time frame: From baseline up to minimum of 7 days post-dose). The study lists 9 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 NCT02661373, which also lists 2 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 2 Jan 2019.