Trial · NCT02717455
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Who Experienced Dose Limiting Toxicities (DLTs) | 4 weeks | Patients who were evaluable for DLT assessment were included in this analysis. Of all 53 patients enrolled, 7 patients were not evaluable for DLT assessment: 4 patients received less than required dose of study drug, 2 patients did not start protocol therapy, and 1 patient had insufficient labs to monitor for DLTs. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Maximum Tolerated Dose (MTD) of Panobinostat in Stratum 1 | 4 weeks | Patients who were enrolled on stratum 1 and were evaluable for dose finding assessment were used to determine the MTD for stratum 1. Of 19 patients enrolled on stratum 1, 2 patients were not evaluable for dose finding assessment due to receiving less than required dose of study drug. The remaining 17 patients were used to determine the MTD for stratum I. | mg/m^2/day | NUMBER |
| PRIMARY | Maximum Tolerated Dose (MTD) of Panobinostat in Stratum 2 | 4 weeks | Patients who were enrolled on stratum 2 and were evaluable for dose finding assessment were used to determine the MTD for stratum 2. Of 34 patients enrolled on stratum 2, 5 patients were not evaluable due to: receiving less than required dose of study drug (2), disease progression before active treatment (1), withdrawal/refusal prior to protocol therapy (1), and insufficient labs to monitor for dose-limiting toxicities (1). The remaining 29 patients were used to determine the MTD for stratum 2. | mg/m^2/day | NUMBER |
| PRIMARY | Volume of Distribution (Vd) | Up to day 3 | Patients who had PK samples collected and had Vd data available were included in this analysis. | L | MEAN |
| PRIMARY | Elimination Rate (Kel) | Up to day 3 | Patients who had PK samples collected and had Kel data available were included in this analysis. | per hour | MEAN |
| PRIMARY | Half-life (t1/2) | Up to day 3 | Patients who had PK samples collected and had t1/2 data available were included in this analysis. | hour | MEAN |
| PRIMARY | Clearance (CL/F) | Up to day 3 | Patients who had PK samples collected and had CL/F data available were included in this analysis. | L/h | MEAN |
| PRIMARY | Area Under the Curve (AUC) | Up to day 3 | Patients who had PK samples collected and had AUC data available were included. | h*ng/mL | MEAN |
| SECONDARY | Progression-free Survival (PFS) in Stratum 1 | From date on treatment until date of PD or death due to any cause or date of last follow-up | Recurrent/progressive DIPG patients who were enrolled on stratum 1 and received at least one dose of panobinostat were included in the analysis. Per the associated protocol objective, all dose levels on stratum 1 were combined to estimate the PFS for this stratum. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) in Stratum 1 | From date on treatment until date of death due to any cause or date of last follow-up | Recurrent/progressive DIPG patients who were enrolled on stratum 1 and received at least one dose of panobinostat were included in the analysis. Per the associated protocol objective, all dose levels on stratum 1 were combined to estimate the OS for this stratum. | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) in Stratum 2 | From date on treatment until date of PD or death due to any cause or date of last follow-up | Non-progressed DIPG or H3K27M+ thalamic DMG patients who were enrolled on stratum 2 and received at least one dose of panobinostat were included in the analysis. Per the associated protocol objective, all dose levels on stratum 2 were combined to estimate the PFS for this stratum. Two patients who did not start protocol therapy were excluded. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) in Stratum 2 | From date on treatment until date of death due to any cause or date of last follow-up | Non-progressed DIPG or H3K27M+ thalamic DMG patients who were enrolled on stratum 2 and received at least one dose of panobinostat were included in the analysis. Per the associated protocol objective, all dose levels on stratum 2 were combined to estimate the OS for this stratum. Two patients who did not start protocol therapy were excluded. | months | MEDIAN |
| SECONDARY | Percentage of Patients With H3F3A K27M Mutation Detected in Blood Samples | Blood samples were collected for cell-free DNA based assay at Course 1 Day 1 (C1D1), C2D1, C4D1, and C6D1. | Only patients with cell-free DNA assay results available from blood samples were included in this analysis. Per the statistical section in the protocol, percentage of patients in whom the mutation was detected was summarized within each stratum and at each time point. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients With Hist1H3B K27M Mutation Detected in Blood Samples | Blood samples were collected for cell-free DNA based assay at Course 1 Day 1 (C1D1), C2D1, C4D1, and C6D1. | Only patients with cell-free DNA assay results available from blood samples were included in this analysis. Per the statistical section in the protocol, percentage of patients in whom the mutation was detected was summarized within each stratum and at each time point. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients With H3F3A K27M Mutation Detected in Urine Samples | Urine samples were collected for cell-free DNA based assay at Course 1 Day 1 (C1D1), C2D1, C4D1, and C6D1. | |||
| SECONDARY | Percentage of Patients With Hist1H3B K27M Mutation Detected in Urine Samples | Urine samples were collected for cell-free DNA based assay at Course 1 Day 1 (C1D1), C2D1, C4D1, and C6D1. |
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.
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