NCT02595931

M6620 and Irinotecan Hydrochloride in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery

Phase I Clinical Trial of M6620 (VX-970, Berzosertib) in Combination With the Topoisomerase I Inhibitor Irinotecan in Patients With Advanced Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of M6620 and irinotecan hydrochloride in treating patients with solid tumors that have spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). M6620 and irinotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVE: I. To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of M6620 (VX-970, berzosertib) in combination with irinotecan hydrochloride (irinotecan) in patients with advanced solid tumors. SECONDARY OBJECTIVES: I. To estimate the safety and tolerability of M6620 (VX-970, berzosertib) in combination with irinotecan. II. To document anti-tumor activity. III. To determine the pharmacokinetic (PK) and pharmacodynamic (PD) parameters of M6620 (VX-970, berzosertib) and irinotecan. EXPLORATORY OBJECTIVE: I. To identify molecular subpopulations of patients with increased sensitivity to the irinotecan and M6620 (VX-970, berzosertib) combination. OUTLINE: This is a dose-escalation study. Patients receive irinotecan hydrochloride intravenously (IV) over 90 minutes and M6620 IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo biopsy and collection of blood samples throughout the study and undergo CT at screening, throughout the study, and during follow up. After completion of study treatment, patients are followed up for 30 days, then at 3 and 6 months.

Conditions

• Metastatic Colorectal Carcinoma
• Metastatic Lung Small Cell Carcinoma
• Metastatic Malignant Solid Neoplasm
• Metastatic Pancreatic Carcinoma
• Refractory Colorectal Carcinoma
• Refractory Lung Small Cell Carcinoma
• Refractory Malignant Solid Neoplasm
• Refractory Pancreatic Carcinoma
• Stage III Colorectal Cancer AJCC v8
• Stage III Lung Cancer AJCC v8
• Stage III Pancreatic Cancer AJCC v8
• Stage IV Colorectal Cancer AJCC v8
• Stage IV Lung Cancer AJCC v8
• Stage IV Pancreatic Cancer AJCC v8
• Unresectable Colorectal Carcinoma
• Unresectable Lung Small Cell Carcinoma
• Unresectable Malignant Solid Neoplasm
• Unresectable Pancreatic Carcinoma

Interventions

Type	Name	Description
DRUG	Berzosertib	Given IV
PROCEDURE	Biopsy Specimen	Undergo biopsy
PROCEDURE	Biospecimen Collection	Correlative studies
PROCEDURE	Computed Tomography	Undergo CT
DRUG	Irinotecan Hydrochloride	Given IV

Timeline

• Start date: 2016-07-22
• Primary completion: 2023-03-07
• Completion: 2027-03-06
• First posted: 2015-11-04
• Last updated: 2026-04-13

Locations

23 sites across 1 country: United States