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Methods of treating cancer in pediatric patients

A cancer, patient technology that addresses unmet needs and more in the field of cancer for pediatric patients

Pending Publication Date: 2020-11-24
TAKEDA PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Nonetheless, a major goal of ongoing research must include identifying treatment options to prevent recurrence in patients with known high-risk ALCL for whom there remains an unmet need for better therapies

Method used

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  • Methods of treating cancer in pediatric patients
  • Methods of treating cancer in pediatric patients
  • Methods of treating cancer in pediatric patients

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0118] Example 1: Inferences and Correlations Between Adult and Pediatric Populations

[0119] Since no pediatric clinical PK data for brigatinib are currently available, the pediatric clinical PK of brigatinib was extrapolated from the adult PK using an allometric protocol. Key aspects of this analysis are summarized below.

[0120] The use of an allotropic ratio regimen is supported by knowledge of the mechanism of clearance of brigatinib and its corresponding ontogeny, suggesting that clearance in pediatric patients >1 year of age is well established. Therefore, simulations based on a previously developed population PK model have been performed to guide dose selection for a pediatric phase 1 dose-confirmation study taking into account dosing regimens against ALK+ NSCLC in adults. The proposed study is an open-label Phase 1 dose escalation in patients ≥2 years of age with measurable or evaluable ALK+ solid or CNS tumors or therapy-refractory ALCL for which no known curative...

Embodiment 2

[0131] Example 2: Pediatric Clinical Research

[0132] general strategy

[0133] Two clinical studies of brigatinib in patients 2 years of age and older with ALCL or IMT: (a) an open-label, Phase 1 / 2 dose-escalation and extension study (Study 1) and (b) Phase 2 randomized study (Study 2).

[0134] During the Phase 1 portion of Study 1, dose escalation of brigatinib monotherapy was performed according to any Rolling-6 design (partial A-1). Upon determination of RP2D for brigatinib monotherapy, open Phase 2 disease-specific expansion cohort and enroll patients with unresectable or relapsed ALK+IMT (Part B cohort B-1) or relapsed / refractory ALK Patients with +ALCL (part B cohort B-2). At this time, in newly diagnosed ALK+ALCL patients at high risk of relapse, dose escalation was also initiated using brigatinib in combination with the standard chemotherapy regimen (ALCL99 regimen) to determine the efficacy of brigatinib when used in combination with ALCL99 Neil's RP2D (Part A...

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Abstract

Provided herein are methods for treating cancers (e.g., inflammatory myofibroblastic tumor, anaplastic large cell lymphoma, and neuroblastoma) in pediatric patients using brigatinib, as monotherapy orcombination therapy with one or more second therapeutic agents.

Description

[0001] This application claims priority to U.S. Provisional Application No. 62 / 645,089, filed March 19, 2018, which is hereby incorporated by reference in its entirety. technical field [0002] Provided herein are methods of treating cancer (e.g., inflammatory myofibroblastic tumor and anaplastic large cell lymphoma) in pediatric patients using brigatinib as monotherapy or in combination with one or more Combination therapy of two therapeutic agents. Background technique [0003] Brigatinib is a novel orally (PO) administered tyrosine kinase inhibitor (TKI). Brigatinib potently inhibits the activating variant of anaplastic lymphoma kinase (ALK). [0004] ALK is a tyrosine kinase encoded on chromosome 2 that plays a physiological role in early brain development. Low expression levels in adults; however, ALK can be altered and become active in a variety of malignancies, including the adult disease, non-small cell lung cancer (NSCLC), and inflammatory myofibroblasts, which pr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/675A61K45/06A61K31/475A61K31/519A61K31/573A61K31/704A61K31/7048A61K31/7068A61P35/00
CPCA61K31/475A61K31/519A61K31/573A61K31/675A61K31/704A61K31/7048A61K31/7068A61K45/06A61P35/00A61K2300/00A61K31/36A61K9/0053A61P35/04
Inventor S·博文M·汉利D·克尔斯坦K·文卡塔克里什南
Owner TAKEDA PHARMA CO LTD