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Also known as Asciminib Pediatric formulation
Asciminib Pediatric formulation group · 1 trial · 1 indication
Goal: identifying the pediatric formulation dose (fed) leading to asciminib exposure comparable to 40 mg BID in adult patients (fasted).
Goal: identifying the pediatric formulation dose (fed) leading to asciminib exposure comparable to 40 mg BID in adult patients (fasted).
Goal: identifying the pediatric formulation dose (fed) leading to asciminib exposure comparable to 40 mg BID in adult patients (fasted).
Goal: identifying the pediatric formulation dose (fed) leading to asciminib exposure comparable to 40 mg BID in adult patients (fasted).
Goal: identifying the pediatric formulation dose (fed) leading to asciminib exposure comparable to 40 mg BID in adult patients (fasted).
| Arm | Type | Description |
|---|---|---|
| Asciminib | EXPERIMENTAL | This arm consists of 2 groups: * The pediatric formulation group where the dose is based on body weight (1.3mg/kg BID or 2.6 mg/kg QD) * The adult formulation group where participants will receive a flat dose of 40mg BID |
| Name | Type | Description |
|---|---|---|
| Asciminib Pediatric formulation group | DRUG | 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 | DRUG | Asciminib Adult formulation group: 40 mg tablets BID, taken orally. 20 mg tablets BID, taken orally. |
Inclusion Criteria: * Male or female participants: * Pediatric formulation group: ≥ 1 and less than 18 years of age at study entry. * Adult formulation group: ≥ 14 and less than 18 years of age and body weight of ≥ 40 kg at study entry. * Participants with Ph+ CML-CP must meet all of the follo...
Asciminib Pediatric formulation is an investigational small molecule being studied for the treatment of Philadelphia positive myeloid leukemia, a type of blood cancer. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and remains under investigation for safety and dosing in pediatric patients.
Asciminib Pediatric formulation is being developed by Novartis AG, a global pharmaceutical company listed on the stock exchange under the ticker symbol NVS. The company is conducting clinical research to evaluate the drug's safety and appropriate dosing in pediatric patients with Philadelphia positive myeloid leukemia.
Asciminib Pediatric formulation is currently in Phase 1 clinical development. This early-stage trial is designed to determine the appropriate dose and assess the safety of the drug in pediatric patients with Philadelphia positive myeloid leukemia. The drug is investigational and has not yet received regulatory approval.
Asciminib Pediatric formulation is being studied in a Phase 1 clinical trial registered as NCT04925479, titled "Study to Determine the Dose and Safety of Asciminib in Pediatric Patients With Chronic Myeloid Leukemia." The trial is currently recruiting participants and aims to enroll 34 patients across multiple countries, including the United States, China, France, Germany, and Japan.
Asciminib Pediatric formulation is also known as Asciminib Pediatric formulation, and it is a pediatric-specific formulation of the drug asciminib. The pediatric formulation is being developed specifically for use in children and adolescents, with a dedicated clinical trial focused on determining the appropriate dose and safety in this younger patient population.
Asciminib Pediatric formulation belongs to the kinase inhibitor class of drugs, specifically a -nib type kinase inhibitor. Kinase inhibitors work by blocking the activity of specific enzymes involved in cancer cell growth. In the context of Philadelphia positive myeloid leukemia, this mechanism is intended to interfere with the signaling pathways that drive the disease.