Trial · NCT04341311
Phase I Study of Marizomib + Panobinostat for Children With DIPG
NCT04341311, Phase 1, Terminated, Dana-Farber Cancer Institute
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase I Study of Marizomib + Panobinostat for Children With DIPG. Trials, record NCT04341311. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04341311
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase I Study of Marizomib + Panobinostat for Children With DIPG
- NCT number
- NCT04341311
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 4 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Diffuse Intrinsic Pontine Glioma, Pediatric Brainstem Glioma, Pediatric Brainstem Gliosarcoma, Recurrent, Pediatric Cancer, Pediatric Brain Tumor, Diffuse Glioma
- Interventions
- Marizomib, Panobinostat
- First posted
- 2020-04-10
- Last updated
- 2024-02-15
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose-limiting toxicity (DLT) of marizomib as a single agent | 28 Days | To determine the toxicity profile and any dose-limiting toxicity (DLT) of marizomib as a single agent at doses up to 0.8 mg/m2 , in children with DIPG |
| Primary | Dose-limiting toxicity (DLT) of marizomib in combination with panobinostat | 28 days | To determine the toxicity profile and any DLT of marizomib at doses up to 0.8 mg/m2 when administered in combination with panobinostat to children with DIPG |
| Primary | Maximum Tolerated Dose of Marizomib (single agent) | 28 Days | To estimate the maximum-tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of marizomib when administered as a single agent in children with DIPG |
| Primary | Maximum Tolerated Dose of Marizomib in combination with panobinostat | 28 Days | To estimate the MTD or RP2D of marizomib when administered in combination with panobinostat in children with DIPG |
| Primary | Pharmacokinetic parameters-volume of the central compartment (Vc/F) | Day 1 Course A1 | Estimated using compartmental methods. Plasma drug concentrations and pharmacokinetic parameters will be presented in tabular and graphical form |
| Primary | Pharmacokinetic parameters-elimination rate constant (Ke), | Course A1, Day 1 | Estimated using compartmental methods. Plasma drug concentrations and pharmacokinetic parameters will be presented in tabular and graphical form |
| Primary | Pharmacokinetic parameters half-life (t1/2) | Course A1, Day 1 | Estimated using compartmental methods. Plasma drug concentrations and pharmacokinetic parameters will be presented in tabular and graphical form |
| Primary | Pharmacokinetic parameters-apparent clearance (CL/F) | Course A1, Day 1 | Estimated using compartmental methods Plasma drug concentrations and pharmacokinetic parameters will be presented in tabular and graphical form |
| Primary | Area under the plasma concentration time curve (AUC) | Course A1, Day 1 | Estimated using compartmental methods Plasma drug concentrations and pharmacokinetic parameters will be presented in tabular and graphical form |
| Secondary | Radiographic progression-free survival (rPFS) | rPFS will be measured from the time of treatment initiation until the time of progressive disease or death from any cause in patients with an event up to 60 Months. | Kaplan-Meier method |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT04341311
GET https://conductscience.org/api/trials/v1/NCT04341311/registered