Study to Determine the Dose and Safety of Asciminib in Pediatric Patients With Chronic Myeloid Leukemia
Condition(s) studied
Investigational drug(s) / intervention(s)
Asciminib Pediatric formulation group: Asciminib Pediatric formulation group: 1 mg film-coated granules in a size 0 capsule will be supplied, taken orally (capsules are a container for the granules and are not ingested): 10 mg (10x 1 mg film-coated granules in capsule) 15 mg (15x 1 mg film-coated granules in capsule) 30 mg (30x 1 mg film-coated granules in capsule)
Asciminib Adult formulation group: Asciminib Adult formulation group: 40 mg tablets BID, taken orally. 20 mg tablets BID, taken orally.
Study summary
The aim of this study is to support development of asciminib in the pediatric population (1 to \<18 years) previously treated with one or more TKIs. Full extrapolation of the efficacy of asciminib from adult to pediatric patients will be conducted. Full extrapolation is based on the concept that CML in the pediatric population has the same pathogenesis, similar clinical characteristics and progression pattern as in adults.
Eligibility
Primary outcome measure(s)
- Primary Pharmacokinetic (PK) parameter: AUClast — 52 weeks
Goal: identifying the pediatric formulation dose (fed) leading to asciminib exposure comparable to 40 mg BID in adult patients (fasted). - Primary PK parameter: AUCtau — 52 weeks
Goal: identifying the pediatric formulation dose (fed) leading to asciminib exposure comparable to 40 mg BID in adult patients (fasted). - Secondary PK parameter: Cmax — 52 weeks
Goal: identifying the pediatric formulation dose (fed) leading to asciminib exposure comparable to 40 mg BID in adult patients (fasted). - Secondary PK parameter: Tmax — 52 weeks
Goal: identifying the pediatric formulation dose (fed) leading to asciminib exposure comparable to 40 mg BID in adult patients (fasted). - Secondary PK parameter: Ctrough — 52 weeks
Goal: identifying the pediatric formulation dose (fed) leading to asciminib exposure comparable to 40 mg BID in adult patients (fasted).
Trial sites (39)
| Facility | City | Region | Status |
|---|---|---|---|
| Indiana UH Riley H for CIU | Indianapolis | Indiana | Active Not Recruiting |
| Dana Farber Cancer Institute | Boston | Massachusetts | Active Not Recruiting |
| University of Mississippi Medical Center | Jackson | Mississippi | Recruiting |
| Columbia University Medical Center New York Presbyterian | New York | New York | Active Not Recruiting |
| Cinn Children Hosp Medical Center | Cincinnati | Ohio | Withdrawn |
| Childrens Hospital of Philadelphia | Philadelphia | Pennsylvania | Withdrawn |
| Uni Of Texas MD Anderson Cancer Ctr | Houston | Texas | Withdrawn |
| University Of Utah | Salt Lake City | Utah | Withdrawn |
| Novartis Investigative Site | Hangzhou | Zhejiang | Withdrawn |
| Novartis Investigative Site | Beijing | China | Active Not Recruiting |
| Novartis Investigative Site | Shanghai | China | Withdrawn |
| Novartis Investigative Site | Tianjin | China | Withdrawn |
| Novartis Investigative Site | Bordeaux | France | Withdrawn |
| Novartis Investigative Site | Lille | France | Active Not Recruiting |
| Novartis Investigative Site | Paris | France | Active Not Recruiting |
| Novartis Investigative Site | Poitiers | France | Withdrawn |
| Novartis Investigative Site | Erlangen | Germany | Active Not Recruiting |
| Novartis Investigative Site | Essen | Germany | Active Not Recruiting |
| Novartis Investigative Site | Hamburg | Germany | Active Not Recruiting |
| Novartis Investigative Site | Athens | Greece | Active Not Recruiting |
| Novartis Investigative Site | Budapest | Hungary | Withdrawn |
| Novartis Investigative Site | Genova | GE | Active Not Recruiting |
| Novartis Investigative Site | Monza | MB | Withdrawn |
| Novartis Investigative Site | Roma | RM | Active Not Recruiting |
| Novartis Investigative Site | Torino | TO | Withdrawn |
| Novartis Investigative Site | Yokohama | Kanagawa | Active Not Recruiting |
| Novartis Investigative Site | Shinjuku-ku | Tokyo | Active Not Recruiting |
| Novartis Investigative Site | Osaka | Japan | Active Not Recruiting |
| Novartis Investigative Site | Utrecht | Netherlands | Active Not Recruiting |
| Novartis Investigative Site | Wroclaw | Poland | Active Not Recruiting |
| Novartis Investigative Site | Moscow | Russia | Withdrawn |
| Novartis Investigative Site | Saint Petersburg | Russia | Withdrawn |
| Novartis Investigative Site | Seoul | South Korea | Active Not Recruiting |
| Novartis Investigative Site | Seoul | South Korea | Active Not Recruiting |
| Novartis Investigative Site | Khon Kaen | THA | Active Not Recruiting |
| Novartis Investigative Site | Bangkok | Thailand | Withdrawn |
| Novartis Investigative Site | Chiang Mai | Thailand | Active Not Recruiting |
| Novartis Investigative Site | Istanbul | Fatih | Active Not Recruiting |
| Novartis Investigative Site | Bursa | Nilufer | Active Not Recruiting |
More Novartis Pharmaceuticals trials in Turkey
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04925479 on ClinicalTrials.gov ↗ ← All trials in Turkey