Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04925609
Status:
RECRUITING
Last Update Posted:
2022-09-28
First Post:
2021-05-17
Brief Title:
Brigatinib in Pediatric and Young Adult Patients With ALK ALCL IMT or Other Solid Tumors
Sponsor:
Princess Maxima Center for Pediatric Oncology
Organization:
Princess Maxima Center for Pediatric Oncology
Study Overview
Official Title:
A Phase III Study of Brigatinib in Pediatric and Young Adult Patients With ALK Anaplastic Large Cell Lymphoma Inflammatory Myofibroblastic Tumors or Other Solid Tumors
Status:
RECRUITING
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Briga-PED
Brief Summary:
This is an open-label phase I-II dose-escalation and expansion study designed to define the recommended dose of brigatinib as monotherapy in pediatric and young adult patients with ALK ALCL IMT or other solid tumors and to evaluate the pharmacokinetics PK long-term safety and efficacy of brigatinib in these children
Detailed Description:
This is an open-label phase I-II dose-escalation and expansion study designed to define the recommended dose of brigatinib as monotherapy in pediatric and young adult patients with ALK ALCL IMT or other solid tumors and to evaluate the pharmacokinetics PK long-term safety and efficacy of brigatinib in these children
Phase 1 part will be a dose escalation part using a rolling-6 design aiming to accrue a minimum of 6 and a maximum of 18 evaluable patients in two dose-levels and minus 1 at least 23 of included patients will be 18 years
Phase 2 will be the tumor cohort expansion part of the study to further evaluate the safety tolerability and clinical activityefficacy of brigatinib as monotherapy in two tumor-specific cohorts
Cohort B1 ALK IMT Planned sample size for Phase 2 is 12 patients with IMT Patients who are included in the monotherapy Phase 1 IMT dose-escalation portion of the study will be included in the expansion cohort analysis if they receive the RP2D and will count towards the total sample size of 12 patients
Cohort B2 ALK ALCL Planned sample size for Phase 2 is 22 patients with ALCL Patients who are included in the monotherapy Phase 1 ALCL dose-escalation portion of the study will be included in the expansion cohort analysis if they receive the RP2D and will count towards the total sample size of 22 patients
Phase 1 part will be a dose escalation part using a rolling-6 design aiming to accrue a minimum of 6 and a maximum of 18 evaluable patients in two dose-levels and minus 1 at least 23 of included patients will be 18 years
Phase 2 will be the tumor cohort expansion part of the study to further evaluate the safety tolerability and clinical activityefficacy of brigatinib as monotherapy in two tumor-specific cohorts
Cohort B1 ALK IMT Planned sample size for Phase 2 is 12 patients with IMT Patients who are included in the monotherapy Phase 1 IMT dose-escalation portion of the study will be included in the expansion cohort analysis if they receive the RP2D and will count towards the total sample size of 12 patients
Cohort B2 ALK ALCL Planned sample size for Phase 2 is 22 patients with ALCL Patients who are included in the monotherapy Phase 1 ALCL dose-escalation portion of the study will be included in the expansion cohort analysis if they receive the RP2D and will count towards the total sample size of 22 patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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