a study on Malignant Solid Neoplasm Metastatic Malignant Neoplasm Metastatic Malignant Solid Neoplasm Refractory Malignant Neoplasm Unresectable Malignant Neoplasm Unresectable Solid Neoplasm Solid Tumor
This phase I trial studies the side effects and best dose of ATR kinase inhibitor VX-970 and irinotecan hydrochloride in treating patients with solid tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or cannot be removed by surgery. ATR kinase inhibitor VX-970 and irinotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Phase I Clinical Trial of VX-970 in Combination With the Topoisomerase I Inhibitor Irinotecan in Patients With Advanced Solid Tumors
I. To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of ATR kinase inhibitor VX-970 (VX-970) in combination with irinotecan hydrochloride (irinotecan) in patients with advanced solid tumors.
I. To estimate the safety and tolerability of VX-970 in combination with irinotecan.
II. To document anti-tumor activity. Anti-tumor activity will be measured by overall response rate (ORR) and progression-free survival (PFS).
III. To determine the pharmacokinetic (PK) and pharmacodynamic (PD) parameters of VX-970 and irinotecan.
I. To identify molecular subpopulations of patients with increased sensitivity to the irinotecan and VX-970 combination.
OUTLINE: This is a dose-escalation study.
Patients receive irinotecan hydrochloride intravenously (IV) over 90 minutes and ATR kinase inhibitor VX-970 IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days, then at 3 and 6 months.
Advanced Malignant Solid Neoplasm Metastatic Malignant Neoplasm Metastatic Malignant Solid Neoplasm Refractory Malignant Neoplasm Unresectable Malignant Neoplasm Unresectable Solid Neoplasm Irinotecan Camptothecin Topoisomerase I Inhibitors
Open to people ages 18 years and up
Patients with uridine diphosphate (UDP) glucuronosyltransferase 1 family, polypeptide A cluster (UGT1A)1*1/28 genotype or *28/28 genotype
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