Trial · NCT02717455
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Who Experienced Dose Limiting Toxicities (DLTs) | 4 weeks | DLTs were defined as adverse events that were at least possibly related to panobinostat that occurred during the first 4 weeks of therapy regardless of expectedness. Hematologic DLTs included grade 4 thrombocytopenia, grade 3 thrombocytopenia with bleeding, grade 3 thrombocytopenia that occurs twice within a treatment course, myelosuppression that causes greater than a 14-day delay between treatment courses, grade 4 neutropenia, grade 3 or 4 febrile neutropenia. Non-hematologic DLTs included any grade 3 or greater non-hematologic toxicities with a few exclusions (such as grade 3 nausea/vomiting that is responsive to antiemetics and that resolves to grade 2 or lower within 5 days, etc.), any grade 2 non-hematological toxicity that persists for more than 7 days and is considered sufficiently medically significant or sufficiently intolerable by patients, and any panobinostat-related non-hematological toxicity that results in a delay of treatment \> 14 days between treatment courses. |
| Primary | Maximum Tolerated Dose (MTD) of Panobinostat in Stratum 1 | 4 weeks | The MTD of panobinostat was defined as the dose at which the continual reassessment method (CRM) estimated that 25% of patients were expected to experience DLTs. Stratum 1 consisted of recurrent or progressive diffuse intrinsic pontine glioma (DIPG) patients who were treated with the "3 times/week, three weeks on, one week off" schedule (1 course = 28 days). |
| Primary | Maximum Tolerated Dose (MTD) of Panobinostat in Stratum 2 | 4 weeks | The MTD of panobinostat was defined as the dose at which the continual reassessment method (CRM) estimated that 25% of patients were expected to experience DLTs. For Stratum 2, non-progressed DIPG or H3K27M+ thalamic diffuse malignant glioma (DMG) patients who completed conventional radiation treatment were eligible. All patients enrolled on this stratum had DIPG tumors and were treated with the "3 times/week, every other week" schedule (1 course = 28 days). |
| Primary | Volume of Distribution (Vd) | Up to day 3 | Plasma samples for pharmacokinetic (PK) analysis were drawn at pre-dose and at 0.5, 1, 2, 4, 8 (±1), 24 (±4) hours after the first dose of panobinostat, as well as prior to the second dose on Course 1 Day 3. Volume of distribution (Vd) was estimated using a noncompartmental method. |
| Primary | Elimination Rate (Kel) | Up to day 3 | Plasma samples for pharmacokinetic (PK) analysis were drawn at pre-dose and at 0.5, 1, 2, 4, 8 (±1), 24 (±4) hours after the first dose of panobinostat, as well as prior to the second dose on Course 1 Day 3. Elimination rate (Kel) was estimated using a noncompartmental method. |
| Primary | Half-life (t1/2) | Up to day 3 | Plasma samples for pharmacokinetic (PK) analysis were drawn at pre-dose and at 0.5, 1, 2, 4, 8 (±1), 24 (±4) hours after the first dose of panobinostat, as well as prior to the second dose on Course 1 Day 3. Half-life (t1/2) was estimated using a noncompartmental method. |
| Primary | Clearance (CL/F) | Up to day 3 | Plasma samples for pharmacokinetic (PK) analysis were drawn at pre-dose and at 0.5, 1, 2, 4, 8 (±1), 24 (±4) hours after the first dose of panobinostat, as well as prior to the second dose on Course 1 Day 3. Clearance (CL/F) was estimated using a noncompartmental method. |
| Primary | Area Under the Curve (AUC) | Up to day 3 | Plasma samples for pharmacokinetic (PK) analysis were drawn at pre-dose and at 0.5, 1, 2, 4, 8 (±1), 24 (±4) hours after the first dose of panobinostat, as well as prior to the second dose on Course 1 Day 3. The area under the curve (AUC) was estimated using a noncompartmental method and calculated from time of dosing to the last measurable concentration. |
| 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 | PFS was measured from the time of treatment initiation until the time of progressive disease (PD) or death due to any cause for patients with an event, or until the time of last follow-up for patients who were progression free. |
| 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 | OS was measured from the time of treatment initiation until the time of death due to any cause for patients who died, or until the time of last follow-up for patients who survived. |
| 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 | PFS was measured from the time of treatment initiation until the time of progressive disease (PD) or death due to any cause for patients with an event, or until the time of last follow-up for patients who were progression free. |
| 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 | OS was measured from the time of treatment initiation until the time of death due to any cause for patients who died, or until the time of last follow-up for patients who survived. |
| 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. | Cell-free DNA based assay was used to determine whether H3F3A K27M mutation could be detected in patients' blood samples. Percentage of patients in whom this mutation was detected was summarized within each stratum and at each time point. |
| 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. | Cell-free DNA based assay was used to determine whether Hist1H3B K27M mutation could be detected in patients' blood samples. Percentage of patients in whom this mutation was detected was summarized within each stratum and at each time point. |
| 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. | Per protocol, cell-free DNA based assay was to be used to determine whether H3F3A K27M mutation could be detected in patients' urine samples, and percentage of patients in whom this mutation was detected would be summarized within each stratum and at each time point. With current technologies available to the lab, no patients had cell-free DNA assay results from urine samples. |
| 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. | Per protocol, cell-free DNA based assay was to be used to determine whether Hist1H3B K27M mutation could be detected in patients' urine samples, and percentage of patients in whom this mutation was detected would be summarized within each stratum and at each time point. With current technologies available to the lab, no patients had cell-free DNA assay results from urine samples. |
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
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