Ignite Creation Date:
2024-05-06 @ 2:39 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02097810
Status:
COMPLETED
Last Update Posted:
2021-06-09
First Post:
2014-03-21
Brief Title:
Study of Oral RXDX-101 in Adult Patients With Locally Advanced or Metastatic Cancer Targeting NTRK1 NTRK2 NTRK3 ROS1 or ALK Molecular Alterations
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Phase 1 Multicenter Open-Label Study of Oral Entrectinib RXDX-101 in Adult Patients With Locally Advanced or Metastatic Cancer Confirmed to be Positive for NTRK1 NTRK2 NTRK3 ROS1 or ALK Molecular Alterations
Status:
COMPLETED
Status Verified Date:
2021-06
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-1
Brief Summary:
Entrectinib RXDX-101 is an orally available inhibitor of the tyrosine kinases TrkA coded by the gene NTRK1 TrkB coded by the gene NTRK2 TrkC coded by the gene NTRK3 ROS1 coded by the gene ROS1 and ALK coded by the gene ALK Molecular alterations to one or more of these targets are present in several different tumor types including non-small cell lung cancer NSCLC colorectal cancer CRC prostate cancer papillary thyroid cancer pancreatic cancer and neuroblastoma Patients with locally advanced or metastatic cancer with a detectable molecular alteration in targets of interest may be eligible for enrollment
Phase 1 will assess safety and tolerability of entrectinib via standard dose escalation scheme and determine the recommended Phase 2 dose Safety and efficacy will be assessed in the dose expansion portion of the study
Phase 1 will assess safety and tolerability of entrectinib via standard dose escalation scheme and determine the recommended Phase 2 dose Safety and efficacy will be assessed in the dose expansion portion of the study
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 |
|---|---|---|---|
| GO40784 | OTHER_GRANT | Hoffmann-La Roche | None |