Participant flow

MTX110 by Convection-Enhanced Delivery in Treating Participants With Newly-Diagnosed Diffuse Intrinsic Pontine Glioma · Source last updated 2022-02-25

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Participant received starting dose of single CED of 30 micrometer of MTX110 on 1 day (day 1); Total volume 3 mL. 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

   id

   FG000

   title

   Phase 1: Starting Dose Level 1 (MTX110)

2. description

   Participant received starting dose of repeated CED of 30 micrometer of MTX110 on n 2 consecutive days (days 1, 2); Total volume 6 mL (3 mL on each day). Panobinostat Nanoparticle Formulation MTX110: Given IT Convection-Enhanced Delivery (CED): Undergo CED

   id

   FG001

   title

   Phase 1: Starting Dose Level 2 (MTX110)

3. description

   Participant received starting dose of repeated CED of 30 micrometer of MTX110 on n 2 consecutive days (days 1, 2); Total volume 8 mL (4 mL on each day). Panobinostat Nanoparticle Formulation MTX110: Given IT Convection-Enhanced Delivery (CED): Undergo CED

   id

   FG002

   title

   Phase 1: Starting Dose Level 3 (MTX110)

4. description

   Participant received starting dose of repeated CED of 30 micrometer of MTX110 on n 2 consecutive days (days 1, 2); Total volume 10 mL (5 mL on each day). Panobinostat Nanoparticle Formulation MTX110: Given IT Convection-Enhanced Delivery (CED): Undergo CED

   id

   FG003

   title

   Phase 1: Starting Dose Level 4 (MTX110)

5. description

   Participant received starting dose of repeated CED of 30 micrometer of MTX110 on n 2 consecutive days (days 1, 2); Total volume 12 mL (6 mL on each day). Panobinostat Nanoparticle Formulation MTX110: Given IT Convection-Enhanced Delivery (CED): Undergo CED

   id

   FG004

   title

   Phase 1: Starting Dose Level 5 (MTX110)

6. description

   Participant received starting dose of repeated CED of 60 micrometer of MTX110 on n 2 consecutive days (days 1, 2); Total volume 12 mL (6 mL on each day). Panobinostat Nanoparticle Formulation MTX110: Given IT Convection-Enhanced Delivery (CED): Undergo CED

   id

   FG005

   title

   Phase 1: Starting Dose Level 6 (MTX110)

7. description

   Participant received starting dose of repeated CED of 90 micrometer of MTX110 on n 2 consecutive days (days 1, 2); Total volume 12 mL (6 mL on each day). Panobinostat Nanoparticle Formulation MTX110: Given IT Convection-Enhanced Delivery (CED): Undergo CED

   id

   FG006

   title

   Phase 1: Starting Dose Level 7 (MTX110)

8. description

   Participants will receive Recommended Phase 2 Dose (RP2D) Panobinostat Nanoparticle Formulation MTX110: Given IT Convection-Enhanced Delivery (CED): Undergo CED

   id

   FG007

   title

   Phase 2

periods

1. milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         1

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         4

      8. group Id

         FG007

         num Subjects

         0

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         1

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         4

      8. group Id

         FG007

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Each participant was permitted to have a dose-escalation assigned to subsequent rounds of CED treatment upon review of safety data at each round. A dose-escalation during treatment in a previous participant, determined the starting dosage assigned to the next participant. The first three participants enrolled received escalated doses in the second or third round of CED treatment.

recruitment Details

All participants were only enrolled into Phase 1 of the clinical trial. The phase 2 expansion cohort was not activated for enrollment at behest of pharmaceutical supplier.

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Preserved source evidence · Not medical advice