Trial · NCT03280030
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Safety Events (Part 1, Japan Only) | up to Day 21 of the first Consolidation cycle; cycle = 28 days | Percentage of Safety Events, defined as death or serious adverse event leading to treatment discontinuation that occurs on or before Day 21 of the first Consolidation cycle. This was determined by the Independent Safety Committee (ISC) to be definitely or probably related to midostaurin. Percentage was calculated based on the percentage of subjects with safety event out of 3 evaluable subjects in Part 1. |
| Primary | Event Free Survival (EFS) (Part 2 - Randomized, Controlled) | up to 3 years after last patient started treatment | Event Free survival is defined as the time from the date of randomization until an EFS event is observed. An EFS event is defined as a failure to obtain a complete remission (CR) within an induction 2, relapse after CR, or death due to any cause, whichever occurs first. The objective was to evaluate the efficacy based on EFS of midostaurin versus placebo in combination with daunorubicin/cytarabine induction, with high-dose cytarabine consolidation, and with midostaurin single agent continuation therapy in newly diagnosed patients with FLT3-mutated AML. |
| Secondary | Overall Survival | up to 3 years after last patient started treatment | Overall survival defined as the time from the date of randomization to date of death due to any cause |
| Secondary | Percentage of Participants With Complete Remission (CR) | up to 3 years after last patient started treatment | Complete Remission is defined as the percentage of participants with a CR according to Chelson Criteria, at various timepoints |
| Secondary | Percentage of Participants With Cumulative Incidence of Relapse (CIR) | up to 3 years after last patient started treatment | CIR (only for patients who achieved CR after study treatment initiation), is measured from the date of first CR to relapse or death due to AML, whichever occurs first. |
| 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 | Evaluate AUClast \& AUC0-t PK parameters for midostaurin. AUClast: The AUC from time zero to the last measurable concentration sampling time (Tlast) (mass x time x volume-1) AUC0-t: The area under the curve (AUC) from time zero to a measurable concentration sampling time (t) (mass x time x volume-1). |
| Secondary | Pharmakinetics (PK) for Midostaurin: Cmax | Induction Phase: Pre-dose and 1, 3, 6 and 12 hours post dose in Cycle 1 Day 8 | Evaluate Cmax parameter for midostaurin. Cmax: The maximum (peak) observed plasma drug concentration after the first dose administration of midostaurin (mass x volume-1). |
| Secondary | Metabolite CGP52421: PK Parameters AUClast, AUC0-t | Induction Phase: Cycle 1 Day 8 | Evaluate the pharmacokinetic of major metabolite of midostaurin CGP52421. AUClast: The AUC from time zero to the last measurable concentration sampling time (Tlast) (mass x time x volume-1) AUC0-t: The area under the curve (AUC) from time zero to a measurable concentration sampling time (t) (mass x time x volume-1). |
| Secondary | Metabolite CGP52421: PK Parameter Cmax | Induction Phase: Cycle 1 Day 8 | Evaluate the pharmacokinetic of major metabolite of midostaurin CGP52421: Cmax. Cmax: The maximum (peak) observed plasma drug concentration after the first dose administration of midostaurin (mass x volume-1). |
| Secondary | Metabolite CGP62221: PK Parameters: AUClast, AUC0-t | Induction Phase: Cycle 1 Day 8 | Evaluate the pharmacokinetic of major metabolite of Midostaurin CGP62221 PK parameters AUClast, AUC0-t |
| Secondary | Metabolite CGP62221: PK Parameter: Cmax | Induction Phase: Cycle 1 Day 8 | Evaluate the pharmacokinetic of major metabolite of Midostaurin CGP62221 PK parameter Cmax. Cmax: The maximum (peak) observed plasma drug concentration after the first dose administration of midostaurin (mass x volume-1). |
| 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 | The EORTC QLQ-C30 is a 30-item questionnaire with multi-item scales and single-item measures, including five functional scales (physical, role, emotional, cognitive, and social), three symptom scales (fatigue, nausea/vomiting, and pain), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial impact), and a global health status/QoL scale. Scores range from 0 to 100, with higher scores indicating higher response levels. High functional scale scores denote healthy functioning, high global QoL scores indicate high QoL, and high symptom scores reflect high symptom levels. Scoring follows the EORTC Scoring Manual, reported by absolute change from baseline. EOI = End of Induction; EOCons = End of Consolidation; EOCont = End of Continuation; EOT = End of Treatment. |
| 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 | The PGIC is a single self-reported item that asks about change in status of subject's overall satisfaction with medication since starting the standalone study. The specific wording of the PGIC is "Directions: Circle the one number that best describes how your overall satisfaction with your medication had changed since starting the study": "Very much improved" =1; "Much improved" =2; "Minimally improved" =3; "No change" =4; "Minimally worse" =5; "Much worse" =6; "Very much worse" =7. PGI-C questions have been widely used to assess the patient perspective of improvement in clinical trials and have shown clinical validity in a variety of indications, including depression, urinary incontinence and adult asthma and the PGIC score determined frequencies and percentages by scheduled timepoint. EOI = End of Induction; EOCons = End of Consolidation; EOCont = End of Continuation; EOT = End of Treatment. |
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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