Trial · NCT04341311
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| 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 |
| Secondary | Overall survival (OS) | time from enrollment until death due to any cause up to 60 Months | Kaplan-Meier method will be used to summarize the time-to-event endpoints, i.e. OS |
| Secondary | Clinical Benefit Score | Baseline, Day 1 of every Cycle up to 2 years. One cycle is 28 days. Higher scores may indicate more clinical benefit. | determined by combination of radiographic assessment, symptoms (patient/parent-reported), clinical (physician or NP) assessment, steroid use, ability to walk, and quality of life (QOL) measure |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT04341311/registered