Ignite Creation Date:
2024-05-06 @ 8:04 AM
Last Modification Date:
2024-10-26 @ 11:55 AM
Study NCT ID:
NCT02650401
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2016-01-04
Brief Title:
Study Of Entrectinib Rxdx-101 in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors AndOr Who Have No Satisfactory Treatment Options
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Phase 12 Open-Label Dose-Escalation And Expansion Study Of Entrectinib Rxdx-101 In Pediatrics With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors AndOr Who Have No Satisfactory Treatment Options
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
STARTRK-NG
Brief Summary:
This is an open-label Phase 12 multicenter dose escalation study in pediatric patients with relapsed or refractory extracranial solid tumors Phase 1 with additional expansion cohorts Phase 2 in patients with primary brain tumors harboring NTRK123 or ROS1 gene fusions and extracranial solid tumors harboring NTRK123 or ROS1 gene fusions
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| CO40778 | OTHER | Hoffmann-La Roche | None |