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Trial · NCT03566199

MTX110 by Convection-Enhanced Delivery in Treating Participants With Newly-Diagnosed Diffuse Intrinsic Pontine Glioma

NCT03566199, Phase 1, Phase 2, Completed, Sabine Mueller, MD, PhD; results first posted 2022-02-25

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. MTX110 by Convection-Enhanced Delivery in Treating Participants With Newly-Diagnosed Diffuse Intrinsic Pontine Glioma. Trials, record NCT03566199. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03566199

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
MTX110 by Convection-Enhanced Delivery in Treating Participants With Newly-Diagnosed Diffuse Intrinsic Pontine Glioma
NCT number
NCT03566199
Status
Completed
Phases
Phase 1, Phase 2
Enrollment
7 participants, actual
Lead sponsor
Sabine Mueller, MD, PhD
Conditions
Diffuse Intrinsic Pontine Glioma
Interventions
Panobinostat Nanoparticle Formulation MTX110, Convection-Enhanced Delivery (CED)
First posted
2018-06-25
Last updated
2022-02-25
Results first posted
2022-02-25
Limitations and caveats
Phase 2 expansion cohort was not activated at behest of pharmaceutical supplier.

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryProportion of Participants With Grade 3 or Higher, Treatment-related, Adverse EventsUp to 12 Months
Adverse events and clinically significant laboratory abnormalities which meet Grade 3, 4, or 5 criteria according to Common Terminology Criteria for Adverse Events (CTCAE) classified by investigators and treating physicians as related to study treatment (probable, possible, and definite) will be summarized by maximum intensity/grade. Adverse events will be graded according to CTCAE version 4.0.
SecondaryOverall Survival Rate (OS) at 12 MonthsUp to 12 MonthsOverall survival is defined as the percentage of participants alive from time of diagnosis up to 12 months.

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYProportion of Participants With Grade 3 or Higher, Treatment-related, Adverse EventsUp to 12 MonthsWhile individual participants were assigned to receive separate doses, participants are presented in one Arm/Group due to confidentiality concerns for this rare disease studyproportion of participantsNUMBER
SECONDARYOverall Survival Rate (OS) at 12 MonthsUp to 12 MonthsWhile individual participants were assigned to receive separate doses, participants are presented in one Arm/Group due to confidentiality concerns for this rare disease studypercentage of participantsNUMBER

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Proportion of Participants With Grade 3 or Higher, Treatment-related, Adverse EventsPhase 1: Treatment (MTX110)Muscle weakness right-sided (Grade 3)0.142proportion of participants
Proportion of Participants With Grade 3 or Higher, Treatment-related, Adverse EventsPhase 1: Treatment (MTX110)Stridor (Grade 3)0.142proportion of participants
Proportion of Participants With Grade 3 or Higher, Treatment-related, Adverse EventsPhase 1: Treatment (MTX110)Vagus nerve disorder (Grade 3)0.142proportion of participants
Proportion of Participants With Grade 3 or Higher, Treatment-related, Adverse EventsPhase 1: Treatment (MTX110)Gait disturbance (Grade 3)0.142proportion of participants
Proportion of Participants With Grade 3 or Higher, Treatment-related, Adverse EventsPhase 1: Treatment (MTX110)Neutrophil count decreased (Grade 3)0.142proportion of participants
Overall Survival Rate (OS) at 12 MonthsPhase 1: Treatment (MTX110)85.795% Confidence Interval 63.3 to 100percentage of participants

Participant flow24

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDPhase 1: Starting Dose Level 1 (MTX110)1
Overall StudySTARTEDPhase 1: Starting Dose Level 2 (MTX110)0
Overall StudySTARTEDPhase 1: Starting Dose Level 3 (MTX110)1
Overall StudySTARTEDPhase 1: Starting Dose Level 4 (MTX110)0
Overall StudySTARTEDPhase 1: Starting Dose Level 5 (MTX110)1
Overall StudySTARTEDPhase 1: Starting Dose Level 6 (MTX110)0
Overall StudySTARTEDPhase 1: Starting Dose Level 7 (MTX110)4
Overall StudySTARTEDPhase 20
Overall StudyCOMPLETEDPhase 1: Starting Dose Level 1 (MTX110)1
Overall StudyCOMPLETEDPhase 1: Starting Dose Level 2 (MTX110)0

Adverse events73

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherFatigueGeneral disordersPhase 1: Treatment (MTX110)475
otherGait disturbanceGeneral disordersPhase 1: Treatment (MTX110)375
otherPainGeneral disordersPhase 1: Treatment (MTX110)378
otherIrritabilityGeneral disordersPhase 1: Treatment (MTX110)171
otherHeadacheNervous system disordersPhase 1: Treatment (MTX110)578
otherAtaxiaNervous system disordersPhase 1: Treatment (MTX110)4717
otherDizzinessNervous system disordersPhase 1: Treatment (MTX110)475
otherAbducens nerve disorderNervous system disordersPhase 1: Treatment (MTX110)374
otherDysarthriaNervous system disordersPhase 1: Treatment (MTX110)277
otherFacial nerve disorderNervous system disordersPhase 1: Treatment (MTX110)272

Adverse event totals3

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityPhase 1: Treatment (MTX110)77
Total, other adverse eventsPhase 1: Treatment (MTX110)77
Total, serious adverse eventsPhase 1: Treatment (MTX110)17

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03566199

GET https://conductscience.org/api/trials/v1/NCT03566199/flow?page=2