Ignite Creation Date:
2024-05-06 @ 1:31 PM
Last Modification Date:
2024-10-26 @ 1:15 PM
Study NCT ID:
NCT04043845
Status:
WITHDRAWN
Last Update Posted:
2020-02-05
First Post:
2019-07-31
Brief Title:
ERK 12 Signaling in Ibrutinib Resistant B-cell Malignancies
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase 1 Study Targeting ERK 12 Signaling in Ibrutinib Resistant B-cell Malignancies
Status:
WITHDRAWN
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business development reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research is studying the safety of combining ibrutinib with the study drug LY3214996 for chronic lymphocytic leukemia CLL Waldenstroms macroglobulinemia WM mantle cell lymphoma MCL or marginal zone lymphoma MZL
Detailed Description:
This research study is a Phase I clinical trial which tests the safety of an investigational combination of drugs and also tries to define the appropriate dose of the investigational drug to use for further studies Investigational means that the drug is being studied
The US Food and Drug Administration FDA has not approved LY3214996 as a treatment for any disease
The US Food and Drug Administration FDA has approved ibrutinib as a treatment option for this disease
LY3214996 is an extracellular signal-regulated kinase ERK inhibitor that is being developed as a treatment for patients with advanced cancer ERK inhibitors stop the signal that a cancer cell receives telling it to grow In this research study the investigators are testing to see if LY3214996 is safe when combined with ibrutinib in patients with specific gene mutations Making treatment decisions based on genetic testing is investigational and the FDA has not approved this genetic testing Several doses of LY3214996 will be explored in this study
The US Food and Drug Administration FDA has not approved LY3214996 as a treatment for any disease
The US Food and Drug Administration FDA has approved ibrutinib as a treatment option for this disease
LY3214996 is an extracellular signal-regulated kinase ERK inhibitor that is being developed as a treatment for patients with advanced cancer ERK inhibitors stop the signal that a cancer cell receives telling it to grow In this research study the investigators are testing to see if LY3214996 is safe when combined with ibrutinib in patients with specific gene mutations Making treatment decisions based on genetic testing is investigational and the FDA has not approved this genetic testing Several doses of LY3214996 will be explored in this study
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