Ignite Creation Date:
2024-05-06 @ 10:30 AM
Last Modification Date:
2024-10-26 @ 12:31 PM
Study NCT ID:
NCT03272464
Status:
TERMINATED
Last Update Posted:
2023-09-22
First Post:
2017-09-01
Brief Title:
INCB039110 in Combination With Dabrafenib and Trametinib in Patients With BRAF-mutant Melanoma and Other Solid Tumors
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Phase I Study of INCB039110 in Combination With Dabrafenib and Trametinib in Patients With BRAF-mutant Melanoma and Other Solid Tumors
Status:
TERMINATED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research study is studying a combination of drugs as a possible treatment for BRAF-mutant melanoma
The drugs involved in this study are
Itacitinib INCB039110
Dabrafenib
Trametinib
The drugs involved in this study are
Itacitinib INCB039110
Dabrafenib
Trametinib
Detailed Description:
This research study is a Phase I clinical trial which tests the safety of the investigational drugs and also tries to define the appropriate doses of the investigational drugs to use for further studies Investigational means that the drugs are being studied
The FDA the US Food and Drug Administration has not approved itacitinib as a treatment for any disease
The FDA has approved dabrafenib and trametinib as a treatment option for Melanoma
In this research study the investigators are studying the combination of itacitinib dabrafenib and trametinib The investigators believe this combination of study drugs may stop the participants cancer cells from growing and spreading All three of the study drugs are inhibitors Trametinib may work by binding to the participants cancer cells to inhibit the cancer cells signals to decrease cell growth dabrafenib may work by stopping the participants cancer cells from duplicating and itacitinib may work by stopping the participants tumor cells from living and growing
The FDA the US Food and Drug Administration has not approved itacitinib as a treatment for any disease
The FDA has approved dabrafenib and trametinib as a treatment option for Melanoma
In this research study the investigators are studying the combination of itacitinib dabrafenib and trametinib The investigators believe this combination of study drugs may stop the participants cancer cells from growing and spreading All three of the study drugs are inhibitors Trametinib may work by binding to the participants cancer cells to inhibit the cancer cells signals to decrease cell growth dabrafenib may work by stopping the participants cancer cells from duplicating and itacitinib may work by stopping the participants tumor cells from living and growing
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?:
False
Is an FDA AA801 Violation?:
None