NCT02631733

Liposomal Irinotecan and Veliparib in Treating Patients With Solid Tumors

A Phase I Study of a Combination of MM-398 and Veliparib in Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (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 veliparib when given together with liposomal irinotecan in treating patients with solid tumors. Liposomal irinotecan and veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the safety and tolerability of escalating doses of liposomal irinotecan (MM-398) + veliparib combination. II. To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of the combination of MM-398 + veliparib. SECONDARY OBJECTIVES: I. To observe and record anti-tumor activity. II. To characterize the preliminary efficacy of the combination using key efficacy indicators, such as objective response rate, clinical benefit rate defined as complete response (CR), partial response (PR), or stable disease (SD) at 24 weeks, and progression free survival (PFS). EXPLORATORY OBJECTIVE: I. Imaging, tumor, and blood biomarkers to assess the sensitivity or resistance to each drug and/or correlation with clinical response. OUTLINE: This is a dose-escalation study of veliparib. Patients receive liposomal irinotecan intravenously (IV) over 90 minutes on days 1 and 15 and veliparib orally (PO) twice daily (BID) on days 5-12 and 19-25 or 3-12 and 17-25. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Within 2-6 days prior to beginning liposomal irinotecan treatment, patients may optionally receive ferumoxytol (FMX) IV and undergo magnetic resonance imaging (MRI) at baseline and 24 hours after FMX infusion. After completion of study treatment, patients are followed up for 4 weeks.

Conditions

• Malignant Solid Neoplasm

Interventions

Type	Name	Description
DRUG	Ferumoxytol	Given IV
DRUG	Irinotecan Sucrosofate	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
DRUG	Veliparib	Given PO

Timeline

• Start date: 2017-05-31
• Primary completion: 2019-11-21
• Completion: 2023-05-24
• First posted: 2015-12-16
• Last updated: 2025-02-10

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study