Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 10:00 PM
Study NCT ID:
NCT04739358
Status:
TERMINATED
Last Update Posted:
2023-10-18
First Post:
2021-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CNS Dose Escalation/Expansion of Tepotinib in MET-driven NSCLC
Sponsor:
Criterium, Inc.
Organization:
Study Overview
Official Title:
A Phase 1/2 Open-Label Study To Determine a Central Nervous System (CNS) Dose and Schedule Of Tepotinib Alone Or In Combination With Other Relevant Tyrosine Kinase Inhibitors (TKIs) In Adult Participants With MET-Driven NSCLC
Status:
TERMINATED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was terminated due to lack of lack of enrollment and difficult patient population.
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will look at how effective the study drug (tepotinib) is at stopping the growth and spread of lung cancer with central nervous system metastasis. In some patients, who have developed resistance to their tyrosine kinase inhibitors (TKIs), this study will look at how effective tepotinib is in combination with TKIs. This study will also measure a number of other things including safety of the study drug and the side effects, how body processes the study drug, or how the study drug affects your quality of life.
Detailed Description:
Phase I - Two arms (Monotherapy and Combination therapy) with primary endpoints of Dose Limiting Toxicity Phase II - Two arms Monotherapy Cohort: Primary endpoint is Intracranial Objective Response Rate Combination Cohort: Primary endpoint is overall and extracranial Objective Response Rate among patients treated with the combination of tepotinib and concurrent TKI.
Study Oversight
Has Oversight DMC:
True
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?: