Ignite Creation Date:
2024-05-06 @ 2:16 PM
Last Modification Date:
2024-10-26 @ 1:27 PM
Study NCT ID:
NCT04260009
Status:
WITHDRAWN
Last Update Posted:
2020-03-05
First Post:
2020-01-22
Brief Title:
Pharmacokinetics Safety and Efficacy of Brigatinib Monotherapy in Pediatric and Young Adult Participants With ALK Anaplastic Large Cell Lymphoma Inflammatory Myofibroblastic Tumors or Other Solid Tumors
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
An Open-Label Phase 12 Dose Escalation and Expansion Trial to Evaluate the Pharmacokinetics Safety and Efficacy of Brigatinib as Monotherapy in Pediatric and Young Adult Patients With ALK Anaplastic Large Cell Lymphoma Inflammatory Myofibroblastic Tumors or Other Solid Tumors
Status:
WITHDRAWN
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business reason unrelated to product safety
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to estimate the maximum tolerated dose MTD recommended phase 2 dose RP2D regimen and characterize the pharmacokinetics PK of brigatinib monotherapy film-coated tablets and age-appropriate formulation AAF administered orally once daily QD in pediatric and young adult participants in Phase 1 and to define the efficacy of brigatinib administered as monotherapy within the disease-specific expansion arms unresectablerecurrent anaplastic lymphoma kinase positive ALK inflammatory myofibroblastic tumor IMT relapsedrefractory ALK anaplastic large cell lymphoma ALCL in Phase 2
Detailed Description:
The drug being tested in this study is called Brigatinib Brigatinib is being tested to treat people who have Anaplastic Large Cell Lymphoma Inflammatory Myofibroblastic Tumors or other solid tumours
The study will enroll approximately 61 patients Participants will be assigned to the following arm group to receive brigatinib
Phase 1 Dose Escalation Brigatinib Dose Level 1 and Dose Level 2 based on safety and tolerability
Phase 2 Dose Expansion Unresectable Recurrent ALK IMT
Phase 2 Dose Expansion Relapsed Refractory ALK ALCL
All participants will be administered brigatinib orally once daily in 28-day Cycles Participants will receive fixed doses of brigatinib based on weight ranges The starting doses in Phase 1 Dose Level 1 are expected to provide systemic exposures of brigatinib in pediatric participants comparable to those achieved in adults receiving the recommended clinical dose of 90 mg once daily for 7 days followed by 180 mg once daily One additional dose level Dose Level 2 is planned in Phase 1 if the initial dose level is tolerated This subsequent dose level is expected to provide systemic exposures of brigatinib in pediatric participants comparable to those achieved in adults receiving 90 mg once daily for 7 days followed by 240 mg once daily the highest acceptably tolerated dose in adults In Phase 2 brigatinib will be administered at the RP2D determined during Phase 1
This multi-centre trial will be conducted worldwide The overall time to participate in this study is approximately 36 months Participants will make multiple visits to the clinic and will be contacted by telephone OR a final visit after receiving their last dose of brigatinib for a follow-up assessment
The study will enroll approximately 61 patients Participants will be assigned to the following arm group to receive brigatinib
Phase 1 Dose Escalation Brigatinib Dose Level 1 and Dose Level 2 based on safety and tolerability
Phase 2 Dose Expansion Unresectable Recurrent ALK IMT
Phase 2 Dose Expansion Relapsed Refractory ALK ALCL
All participants will be administered brigatinib orally once daily in 28-day Cycles Participants will receive fixed doses of brigatinib based on weight ranges The starting doses in Phase 1 Dose Level 1 are expected to provide systemic exposures of brigatinib in pediatric participants comparable to those achieved in adults receiving the recommended clinical dose of 90 mg once daily for 7 days followed by 180 mg once daily One additional dose level Dose Level 2 is planned in Phase 1 if the initial dose level is tolerated This subsequent dose level is expected to provide systemic exposures of brigatinib in pediatric participants comparable to those achieved in adults receiving 90 mg once daily for 7 days followed by 240 mg once daily the highest acceptably tolerated dose in adults In Phase 2 brigatinib will be administered at the RP2D determined during Phase 1
This multi-centre trial will be conducted worldwide The overall time to participate in this study is approximately 36 months Participants will make multiple visits to the clinic and will be contacted by telephone OR a final visit after receiving their last dose of brigatinib for a follow-up assessment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None