Ignite Creation Date:
2024-05-06 @ 1:42 PM
Last Modification Date:
2024-10-26 @ 1:18 PM
Study NCT ID:
NCT04094610
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2019-09-12
Brief Title:
A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK ROS1 OR NTRK1-3 Alterations
Sponsor:
Turning Point Therapeutics Inc
Organization:
Turning Point Therapeutics Inc
Study Overview
Official Title:
A Phase 12 Open-Label Safety Tolerability Pharmacokinetics and Anti-Tumor Activity Study of Repotrectinib in Pediatric and Young Adult Subjects With Advanced or Metastatic Malignancies Harboring ALK ROS1 NTRK1-3 Alterations
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT05926232
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
None
Brief Summary:
Phase 1 will evaluate the safety and tolerability at different dose levels of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring anaplastic lymphoma kinase ALK receptor tyrosine kinase encoded by the gene ROS1 ROS1 or neurotrophic receptor kinase genes encoding TRK kinase family NTRK1-3 alterations to estimate the Maximum Tolerated Dose MTD or Maximum Administered Dose MAD and select the Pediatric Recommended Phase 2 Dose RP2D
Phase 2 will determine the anti-tumor activity of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring ROS1 or NTRK1-3 alterations
Phase 2 will determine the anti-tumor activity of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring ROS1 or NTRK1-3 alterations
Detailed Description:
Enrollment of subjects into Phase 1 will proceed concurrently by age as follows
Subjects 12 years old will initially be enrolled in the Phase 1 part to determine the pediatric RP2D for this age group once the pediatric RP2D is determined subjects age 12 years old may be enrolled into the Phase 2 part of the study
Subjects 12 to 25 years old will be directly enrolled into the Phase 2 part concurrent with Phase 1 enrollment
Phase 1
Approximately 12 pediatric subjects with locally advanced or metastatic solid tumors including a primary central nervous system CNS tumor or anaplastic large cell lymphoma ALCL with disease progression or who are non-responsive or intolerant to available therapies and for which no standard or available curative therapy exists
Phase 2
Subjects will be enrolled in one of 3 cohorts as follows
Cohort 1 approximately 10-20 subjects with solid tumors characterized by NTRK fusion TRK tyrosine kinase inhibitor TKI-naïve and centrally confirmed measurable disease at baseline
Cohort 2 approximately 23 subjects with solid tumors characterized by NTRK fusion TRK TKI-pretreated and centrally confirmed measurable disease at baseline
Cohort 3 approximately 20 subjects with solid tumors or ALCL characterized by other ALKROS1NTRK alterations or NTRK fusions without centrally confirmed measurable disease not otherwise eligible for Cohort 1 or 2 As of the current protocol amendment only patients with ROS1 alterations will be enrolled to this cohort
Subjects 12 years old will initially be enrolled in the Phase 1 part to determine the pediatric RP2D for this age group once the pediatric RP2D is determined subjects age 12 years old may be enrolled into the Phase 2 part of the study
Subjects 12 to 25 years old will be directly enrolled into the Phase 2 part concurrent with Phase 1 enrollment
Phase 1
Approximately 12 pediatric subjects with locally advanced or metastatic solid tumors including a primary central nervous system CNS tumor or anaplastic large cell lymphoma ALCL with disease progression or who are non-responsive or intolerant to available therapies and for which no standard or available curative therapy exists
Phase 2
Subjects will be enrolled in one of 3 cohorts as follows
Cohort 1 approximately 10-20 subjects with solid tumors characterized by NTRK fusion TRK tyrosine kinase inhibitor TKI-naïve and centrally confirmed measurable disease at baseline
Cohort 2 approximately 23 subjects with solid tumors characterized by NTRK fusion TRK TKI-pretreated and centrally confirmed measurable disease at baseline
Cohort 3 approximately 20 subjects with solid tumors or ALCL characterized by other ALKROS1NTRK alterations or NTRK fusions without centrally confirmed measurable disease not otherwise eligible for Cohort 1 or 2 As of the current protocol amendment only patients with ROS1 alterations will be enrolled to this cohort
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TPX-0005-07 | OTHER | Turning Point Therapeutics Protocol ID | None |
| CA127-1029 | OTHER | None | None |