Trial · NCT03280030
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Safety Events (Part 1, Japan Only) | up to Day 21 of the first Consolidation cycle; cycle = 28 days | Patients enrolled in Part 1: 3 patients out of 5 patients in Part 1 were evaluable for safety evaluation as determined by Independent Safety Committee (ISC). | Participants | NUMBER |
| PRIMARY | Event Free Survival (EFS) (Part 2 - Randomized, Controlled) | up to 3 years after last patient started treatment | Full Analysis Set (FAS): The FAS comprised of all subjects to whom study drug (midostaurin/placebo) had been assigned by randomization. Therefore, all Japanese subjects treated during Part 1 were not eligible for the FAS. | Months | MEDIAN |
| SECONDARY | Overall Survival | up to 3 years after last patient started treatment | FAS: The FAS comprised of all subjects to whom study drug (midostaurin/placebo) had been assigned by randomization. Therefore, all Japanese subjects treated during Part 1 were not eligible for the FAS. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Complete Remission (CR) | up to 3 years after last patient started treatment | FAS: The FAS comprised of all subjects to whom study drug (midostaurin/placebo) had been assigned by randomization. Therefore, all Japanese subjects treated during Part 1 were not eligible for the FAS. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Cumulative Incidence of Relapse (CIR) | up to 3 years after last patient started treatment | FAS: The FAS comprised of all subjects to whom study drug (midostaurin/placebo) had been assigned by randomization. Therefore, all Japanese subjects treated during Part 1 were not eligible for the FAS. This analysis was on FAS but only on participants who had achieved a CR. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pharmakinetics (PK) for Midostaurin: AUClast & AUC0-t | Induction Phase: Pre-dose and 1, 3, 6 and 12 hours post dose in Cycle 1 Day 8 | PK analysis set for full PK (PAS-full): The PAS-full included all subjects in the PAS-all, who provide an evaluable PK profile. A profile was considered evaluable if all of the following conditions are satisfied: Subject received the planned dose of midostaurin on C1D8 of induction therapy; Subject did not vomit within 4 hours of the dosing of midostaurin on C1D8 of induction therapy; Subject provided at least one primary PK parameter. | ng*hr/mL | GEOMETRIC_MEAN |
| SECONDARY | Pharmakinetics (PK) for Midostaurin: Cmax | Induction Phase: Pre-dose and 1, 3, 6 and 12 hours post dose in Cycle 1 Day 8 | PAS-full: PK analysis set for full PK (PAS-full): The PAS-full included all subjects in the PAS-all, who provide an evaluable PK profile. A profile was considered evaluable if all of the following conditions are satisfied: Subject received the planned dose of midostaurin on C1D8 of induction therapy; Subject did not vomit within 4 hours of the dosing of midostaurin on C1D8 of induction therapy; Subject provided at least one primary PK parameter. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Metabolite CGP52421: PK Parameters AUClast, AUC0-t | Induction Phase: Cycle 1 Day 8 | PAS-full: PK analysis set for full PK (PAS-full): The PAS-full included all subjects in the PAS-all, who provide an evaluable PK profile. A profile was considered evaluable if all of the following conditions are satisfied: Subject received the planned dose of midostaurin on C1D8 of induction therapy; Subject did not vomit within 4 hours of the dosing of midostaurin on C1D8 of induction therapy; Subject provided at least one primary PK parameter. | ng*hr/mL | GEOMETRIC_MEAN |
| SECONDARY | Metabolite CGP52421: PK Parameter Cmax | Induction Phase: Cycle 1 Day 8 | PAS-full: PK analysis set for full PK (PAS-full): The PAS-full included all subjects in the PAS-all, who provide an evaluable PK profile. A profile was considered evaluable if all of the following conditions are satisfied: Subject received the planned dose of midostaurin on C1D8 of induction therapy; Subject did not vomit within 4 hours of the dosing of midostaurin on C1D8 of induction therapy; Subject provided at least one primary PK parameter. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Metabolite CGP62221: PK Parameters: AUClast, AUC0-t | Induction Phase: Cycle 1 Day 8 | PAS-full: PK analysis set for full PK (PAS-full): The PAS-full included all subjects in the PAS-all, who provide an evaluable PK profile. A profile was considered evaluable if all of the following conditions are satisfied: Subject received the planned dose of midostaurin on C1D8 of induction therapy; Subject did not vomit within 4 hours of the dosing of midostaurin on C1D8 of induction therapy; Subject provided at least one primary PK parameter. | ng*hr/mL | GEOMETRIC_MEAN |
| SECONDARY | Metabolite CGP62221: PK Parameter: Cmax | Induction Phase: Cycle 1 Day 8 | PAS-full: PK analysis set for full PK (PAS-full): The PAS-full included all subjects in the PAS-all, who provide an evaluable PK profile. A profile was considered evaluable if all of the following conditions are satisfied: Subject received the planned dose of midostaurin on C1D8 of induction therapy; Subject did not vomit within 4 hours of the dosing of midostaurin on C1D8 of induction therapy; Subject provided at least one primary PK parameter. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in Quality of Life (QoL) Per European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 | EOI: up to 1.84 months (after 2 cycles); EOCons: up to 5.52 months (after 4 cycles); EOCont: up to 16.56 months (after 12 cycles); EOT: up to 16.56 months maximum, depending on treatment duration; each cycle = 28 days | Participants in the full analysis set (FAS) with an available assessment for the outcome measure at each timepoint. FAS: The FAS comprised of all subjects to whom study drug (midostaurin/placebo) had been assigned by randomization. | scores on a scale | MEAN |
| SECONDARY | Quality of Life (QoL) Per Patient Global Impression of Change (PGIC) | EOI: up to 1.84 months (after 2 cycles); EOCons: up to 5.52 months (after 4 cycles); EOCont: up to 16.56 months (after 12 cycles); EOT: up to 16.56 months maximum, depending on treatment duration; each cycle = 28 days | Participants in the full analysis set (FAS) with an available assessment for the outcome measure at each timepoint. FAS: The FAS comprised of all subjects to whom study drug (midostaurin/placebo) had been assigned by randomization. | Participants | NUMBER |
| POST_HOC | All Collected Deaths | Start of study treatment up to 30 days post-treatment for approx. 1 year, prior to study treatment (before randomization) up to LPLV, approx. 55 months | Clinical Database Population: all enrolled participants | Participants | COUNT_OF_PARTICIPANTS |
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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