Ignite Creation Date:
2024-10-25 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06630416
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-04
Brief Title:
Pemetrexed Response in Relation to Tumor Alterations of Gene Status for the Treatment of Patients With Metastatic Urothelial Bladder Cancer and Other Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase II Trial to Evaluate Pemetrexed Response in Relation to Tumor Alterations of Gene Status in Patients With Previously Treated Metastatic Urothelial Carcinoma and Other Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial tests how well pemetrexed works in treating patients with urothelial bladder cancer and other solid tumors that have spread from where they first started primary site to other places in the body metastatic with mutations that result in a loss of function in the MLL4-proteinKMT2D-gene or UTX-proteinKDM6A-gene or MTAP enzyme Loss of function due to a genetic mutation means a genes activity may be reduced or eliminated Mutations that result in a loss of function in the MLL4-protein or KMT2D-gene are found in 996 of all cancers including bladder carcinoma patients esophageal squamous cell carcinoma and esophageal adenocarcinoma patients In addition mutations that result in a loss of function in the UTX-protein or KDM6A-gene are found in approximately 5 of all tumors including bladder cancers endometrial cancer and esophagogastric cancer amongst many other tumor types Pemetrexed is in a class of medications called antifolate antineoplastic agents It works by stopping cells from using folic acid to make deoxyribonucleic acid and may kill tumor cells Giving pemetrexed may increase response in patients with metastatic urothelial bladder cancer and other solid tumors with the loss of function in the MLL4-proteinKMT2D-gene or UTX-proteinKDM6A-gene or MTAP enzyme
Detailed Description:
PRIMARY OBJECTIVE
I To determine the overall response rate ORR in patients with metastatic solid tumors and MLL4-protein KMT2D-gene and UTX-protein KDM6A-gene or MTAP loss of function mutations treated with pemetrexed will assess pemetrexed
SECONDARY OBJECTIVES
I To determine the progression-free survival PFS for patients with metastatic solid tumors and MLL4-protein KMT2D-gene and UTX-protein KDM6A-gene or MTAP loss of function mutations treated with pemetrexed
II To determine the overall survival OS for patients with metastatic solid tumors and MLL4-protein KMT2D-gene and UTX-protein KDM6A-gene or MTAP loss of function mutations treated with pemetrexed
III To determine the duration of response DOR for patients with metastatic solid tumors and MLL4-protein KMT2D-gene and UTX-protein KDM6A-gene or MTAP loss of function mutations treated with pemetrexed
IV To assess safety and tolerability of pemetrexed in patients with metastatic solid treated with pemetrexed
EXPLORATORY OBJECTIVE
I To collect plasma and urine samples for future translational studies to determine mechanisms of resistance to pemetrexed
OUTLINE
Patients receive pemetrexed intravenously IV over 10 minutes on day 1 of each cycle Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients undergo blood and urine sample collection on study as well as computed tomography CT throughout the trial
After completion of study treatment patients are followed up every 3 months for up to 12 months
I To determine the overall response rate ORR in patients with metastatic solid tumors and MLL4-protein KMT2D-gene and UTX-protein KDM6A-gene or MTAP loss of function mutations treated with pemetrexed will assess pemetrexed
SECONDARY OBJECTIVES
I To determine the progression-free survival PFS for patients with metastatic solid tumors and MLL4-protein KMT2D-gene and UTX-protein KDM6A-gene or MTAP loss of function mutations treated with pemetrexed
II To determine the overall survival OS for patients with metastatic solid tumors and MLL4-protein KMT2D-gene and UTX-protein KDM6A-gene or MTAP loss of function mutations treated with pemetrexed
III To determine the duration of response DOR for patients with metastatic solid tumors and MLL4-protein KMT2D-gene and UTX-protein KDM6A-gene or MTAP loss of function mutations treated with pemetrexed
IV To assess safety and tolerability of pemetrexed in patients with metastatic solid treated with pemetrexed
EXPLORATORY OBJECTIVE
I To collect plasma and urine samples for future translational studies to determine mechanisms of resistance to pemetrexed
OUTLINE
Patients receive pemetrexed intravenously IV over 10 minutes on day 1 of each cycle Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients undergo blood and urine sample collection on study as well as computed tomography CT throughout the trial
After completion of study treatment patients are followed up every 3 months for up to 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None