Liposomal Irinotecan and Veliparib in Treating Patients With Solid Tumors

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02631733
Phase
PHASE1
Status
Completed

Conditions

  • Malignant Solid Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 31, 2017
Status verified
Feb 2025
Primary completion
Nov 21, 2019
Completion
May 24, 2023

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (liposomal irinotecan, veliparib)
    Patients receive liposomal irinotecan IV over 90 minutes on days 1 and 15 and veliparib PO 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 FMX IV and undergo MRI at baseline and 24 hours after FMX infusion.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Up to 4 weeks ]

Locations (6)

FacilityCityStateZIPSite coordinators
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287-
National Institutes of Health Clinical CenterBethesdaMaryland20892-
NCI - Center for Cancer ResearchBethesdaMaryland20892-
Mayo Clinic in RochesterRochesterMinnesota55905-
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterNew YorkNew York10032-
Cleveland Clinic FoundationClevelandOhio44195-

Find similar trials in Baltimore, MD

By research site
Johns Hopkins University/Sidney Kimmel Cancer Center· Baltimore, MDNational Institutes of Health Clinical Center· Bethesda, MDNCI - Center for Cancer Research· Bethesda, MDMayo Clinic in Rochester· Rochester, MNNYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center· New York, NYCleveland Clinic Foundation· Cleveland, OH

Related Studies