NCT03566199 · STUDY IN CONTEXT
MTX110 by Convection-Enhanced Delivery in Treating Participants With Newly-Diagnosed Diffuse Intrinsic Pontine Glioma
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
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.
Overall survival is defined as the percentage of participants alive from time of diagnosis up to 12 months.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-diffuse-intrinsic-pontine-glioma-dipg
- nct id
- NCT03566199
- trial label
- MTX110 by Convection-Enhanced Delivery in Treating Participants With Newly-Diagnosed Diffuse Intrinsic Pontine Glioma
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 2
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-diffuse-intrinsic-pontine-glioma-dipg
- nct id
- NCT03566199
- outcome key
- om-0000
- source section id
- NCT03566199-om-0000
- source outcome index
- 0
- endpoint
- Proportion of Participants With Grade 3 or Higher, Treatment-related, Adverse Events
- endpoint definition
- 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.
- time origin
- Up to 12 Months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-diffuse-intrinsic-pontine-glioma-dipg
- nct id
- NCT03566199
- outcome key
- om-0001
- source section id
- NCT03566199-om-0001
- source outcome index
- 1
- endpoint
- Overall Survival Rate (OS) at 12 Months
- endpoint definition
- Overall survival is defined as the percentage of participants alive from time of diagnosis up to 12 months.
- time origin
- Up to 12 Months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-diffuse-intrinsic-pontine-glioma-dipg
- nct id
- NCT03566199
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Phase 1: Treatment (MTX110)
- regimen
- Participants receive panobinostat nanoparticle formulation MTX110 IT by CED infusion on day 1 or days 1 and 2 as determined by dose level. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Panobinostat Nanoparticle Formulation MTX110: Given IT Convection-Enhanced Delivery (CED): Undergo CED
- analyzed count
- 7
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03566199-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-diffuse-intrinsic-pontine-glioma-dipg
- nct id
- NCT03566199
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Phase 1: Treatment (MTX110)
- regimen
- Participants receive panobinostat nanoparticle formulation MTX110 IT by CED infusion on day 1 or days 1 and 2 as determined by dose level. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Panobinostat Nanoparticle Formulation MTX110: Given IT Convection-Enhanced Delivery (CED): Undergo CED
- analyzed count
- 7
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03566199-om-0001#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-diffuse-intrinsic-pontine-glioma-dipg
- nct id
- NCT03566199
- harm key
- EG000
- source section id
- NCT03566199-ae
- event group key
- EG000
- event group label
- Phase 1: Treatment (MTX110)
- serious affected
- 1
- serious at risk
- 7
- other affected
- 7
- other at risk
- 7
- frequency threshold
- 5
- collection period
- Up to 24 months
- event definition
- Additional adverse event and mortality data was collected for participants for up to 24 months following initial diagnosis. 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.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice
Triangle