Ignite Creation Date:
2024-05-06 @ 4:01 PM
Last Modification Date:
2024-10-26 @ 2:02 PM
Study NCT ID:
NCT04849273
Status:
TERMINATED
Last Update Posted:
2023-05-26
First Post:
2021-04-12
Brief Title:
A Study of TPX-0131 a Novel Oral ALK Tyrosine Kinase Inhibitor in Patients With ALK Advanced or Metastatic NSCLC
Sponsor:
Turning Point Therapeutics Inc
Organization:
Turning Point Therapeutics Inc
Study Overview
Official Title:
A Phase 12 Study of TPX-0131 A Novel Oral ALK Tyrosine Kinase Inhibitor in Subjects With ALK Advanced or Metastatic NSCLC
Status:
TERMINATED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Adverse change in the riskbenefit
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A phase 1 first-in-human open-label study to evaluate the safety tolerability PK and efficacy of the novel ALK inhibitor TPX-0131 in pretreated subjects with ALK advanced or metastatic non-small cell lung cancer NSCLC
Detailed Description:
Phase 1 Dose Escalation To evaluate the overall safety profile efficacy of TPX-0131 in pretreated subjects with ALK advanced or metastatic NSCLC
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-0131-01 | OTHER | Turning Point Therapeutics Protocol ID | None |
| CA226-1036 | OTHER | None | None |