Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04835714
Status:
TERMINATED
Last Update Posted:
2023-02-01
First Post:
2021-04-06
Brief Title:
A Study to Find a Safe and Effective Dose of BI 1701963 Alone and in Combination With BI 3011441 in Patients With Advanced Cancer and a Certain Mutation Kirsten Rat Sarcoma Viral Oncogene Homologue KRAS
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Phase I Open-label Dose Escalation Trial of BI 1701963 as Monotherapy and in Combination With BI 3011441 in Patients With KRAS Mutated Advanced or Metastatic Solid Tumours
Status:
TERMINATED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a study in adults with advanced cancer solid tumours including non-small cell lung cancer and colorectal cancer in whom previous chemotherapy was not successful People who have a tumour with a KRAS mutation can participate in the study A KRAS mutation makes cancer grow faster
The study tests 2 medicines called BI 1701963 and BI 3011441 BI 1701963 and BI 3011441 prevent activation of KRAS
The purpose of this study is to find out the highest dose of BI 1701963 alone and in combination with BI 3011441 the participants can tolerate Another purpose is to check whether BI 1701963 in combination with BI 3011441 is able to make tumours shrink
Participants can stay in the study as long as they benefit from treatment and can tolerate it During this time they get tablets of BI 1701963 and capsules of BI 3011441 once daily The doctors regularly monitor the size of the tumour Doctors also regularly record any unwanted effects and check participants health
The study tests 2 medicines called BI 1701963 and BI 3011441 BI 1701963 and BI 3011441 prevent activation of KRAS
The purpose of this study is to find out the highest dose of BI 1701963 alone and in combination with BI 3011441 the participants can tolerate Another purpose is to check whether BI 1701963 in combination with BI 3011441 is able to make tumours shrink
Participants can stay in the study as long as they benefit from treatment and can tolerate it During this time they get tablets of BI 1701963 and capsules of BI 3011441 once daily The doctors regularly monitor the size of the tumour Doctors also regularly record any unwanted effects and check participants health
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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