Phase I Study of Marizomib + Panobinostat for Children With DIPG
NCT04341311 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4
Last updated 2024-02-15
Summary
This research study is evaluating the safety, tolerability and preliminary efficacy of the drugs marizomib and panobinostat in pediatric patients with diffuse intrinsic pontine glioma (DIPG).
The names of the study drugs involved in this study are:
* Marizomib
* Panobinostat
Conditions
- Diffuse Intrinsic Pontine Glioma
- Pediatric Brainstem Glioma
- Pediatric Brainstem Gliosarcoma, Recurrent
- Pediatric Cancer
- Pediatric Brain Tumor
- Diffuse Glioma
Interventions
- DRUG
-
Marizomib
\- Intravenously initially given every other week over a 28 day course but will go to weekly x 3 and weekly x 4 as the dose levels increase Up to 26 courses.
- DRUG
-
Panobinostat
\- Panobinostat: Oral dosage is given 3 times weekly, every other week over a 28 day course
Sponsors & Collaborators
-
Celgene
collaborator INDUSTRY -
Secura Bio, Inc.
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Katherine Warren, MD · Dana-Farber Cancer Institute
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Max Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-08-10
- Primary Completion
- 2024-02-14
- Completion
- 2024-02-14
- FDA Drug
- Yes
Countries
- United States
Study Locations
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