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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Participants With Grade 3 or Higher, Treatment-related, Adverse Events | Up 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. |
| Secondary | Overall Survival Rate (OS) at 12 Months | Up to 12 Months | Overall survival is defined as the percentage of participants alive from time of diagnosis up to 12 months. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Participants With Grade 3 or Higher, Treatment-related, Adverse Events | Up to 12 Months | While individual participants were assigned to receive separate doses, participants are presented in one Arm/Group due to confidentiality concerns for this rare disease study | proportion of participants | NUMBER |
| SECONDARY | Overall Survival Rate (OS) at 12 Months | Up to 12 Months | While individual participants were assigned to receive separate doses, participants are presented in one Arm/Group due to confidentiality concerns for this rare disease study | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Participants With Grade 3 or Higher, Treatment-related, Adverse Events | Phase 1: Treatment (MTX110) | Muscle weakness right-sided (Grade 3) | 0.142 | proportion of participants | |
| Proportion of Participants With Grade 3 or Higher, Treatment-related, Adverse Events | Phase 1: Treatment (MTX110) | Stridor (Grade 3) | 0.142 | proportion of participants | |
| Proportion of Participants With Grade 3 or Higher, Treatment-related, Adverse Events | Phase 1: Treatment (MTX110) | Vagus nerve disorder (Grade 3) | 0.142 | proportion of participants | |
| Proportion of Participants With Grade 3 or Higher, Treatment-related, Adverse Events | Phase 1: Treatment (MTX110) | Gait disturbance (Grade 3) | 0.142 | proportion of participants | |
| Proportion of Participants With Grade 3 or Higher, Treatment-related, Adverse Events | Phase 1: Treatment (MTX110) | Neutrophil count decreased (Grade 3) | 0.142 | proportion of participants | |
| Overall Survival Rate (OS) at 12 Months | Phase 1: Treatment (MTX110) | 85.7 | 95% Confidence Interval 63.3 to 100 | percentage of participants |
Source ClinicalTrials.gov
Participant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1: Starting Dose Level 1 (MTX110) | 1 | |
| Overall Study | STARTED | Phase 1: Starting Dose Level 2 (MTX110) | 0 | |
| Overall Study | STARTED | Phase 1: Starting Dose Level 3 (MTX110) | 1 | |
| Overall Study | STARTED | Phase 1: Starting Dose Level 4 (MTX110) | 0 | |
| Overall Study | STARTED | Phase 1: Starting Dose Level 5 (MTX110) | 1 | |
| Overall Study | STARTED | Phase 1: Starting Dose Level 6 (MTX110) | 0 | |
| Overall Study | STARTED | Phase 1: Starting Dose Level 7 (MTX110) | 4 | |
| Overall Study | STARTED | Phase 2 | 0 | |
| Overall Study | COMPLETED | Phase 1: Starting Dose Level 1 (MTX110) | 1 | |
| Overall Study | COMPLETED | Phase 1: Starting Dose Level 2 (MTX110) | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events73
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fatigue | General disorders | Phase 1: Treatment (MTX110) | 4 | 7 | 5 |
| other | Gait disturbance | General disorders | Phase 1: Treatment (MTX110) | 3 | 7 | 5 |
| other | Pain | General disorders | Phase 1: Treatment (MTX110) | 3 | 7 | 8 |
| other | Irritability | General disorders | Phase 1: Treatment (MTX110) | 1 | 7 | 1 |
| other | Headache | Nervous system disorders | Phase 1: Treatment (MTX110) | 5 | 7 | 8 |
| other | Ataxia | Nervous system disorders | Phase 1: Treatment (MTX110) | 4 | 7 | 17 |
| other | Dizziness | Nervous system disorders | Phase 1: Treatment (MTX110) | 4 | 7 | 5 |
| other | Abducens nerve disorder | Nervous system disorders | Phase 1: Treatment (MTX110) | 3 | 7 | 4 |
| other | Dysarthria | Nervous system disorders | Phase 1: Treatment (MTX110) | 2 | 7 | 7 |
| other | Facial nerve disorder | Nervous system disorders | Phase 1: Treatment (MTX110) | 2 | 7 | 2 |
1 to 10 of 73Source ClinicalTrials.gov
See all 73 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1: Treatment (MTX110) | 7 | 7 |
| Total, other adverse events | Phase 1: Treatment (MTX110) | 7 | 7 |
| Total, serious adverse events | Phase 1: Treatment (MTX110) | 1 | 7 |
Source ClinicalTrials.gov
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.
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