MM-398 (Nanoliposomal Irinotecan, Nal-IRI) to Determine Tumor Drug Levels and to Evaluate the Feasibility of Ferumoxytol Magnetic Resonance Imaging to Measure Tumor Associated Macrophages and to Predict Patient Response to Treatment

PHASE1CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

November 30, 2012

Primary Completion Date

October 2, 2018

Study Completion Date

October 2, 2018

Conditions
Solid TumorsER/PR Positive Breast CancerTriple Negative Breast CancerMetastatic Breast Cancer With Active Brain Metastasis
Interventions
DRUG

Ferumoxytol

Ferumoxytol 5 mg/kg IV as a single bolus injection, given once.

DRUG

MM-398

MM-398 IV over 90 min every 2 weeks, until progressive disease or intolerable toxicity

Trial Locations (7)

27599

UNC- Lineberger Comprehensive Cancer Center, Chapel Hill

33607

Moffitt Cancer Center, Tampa

48109

University of Michighan Comprehensive Cancer Center, Ann Arbor

63110

Washington University, St Louis

85258

HonorHealth, Scottsdale

94115

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco

85159-5499

Mayo Clinic, Scottsdale

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Ipsen

INDUSTRY

NCT01770353 - MM-398 (Nanoliposomal Irinotecan, Nal-IRI) to Determine Tumor Drug Levels and to Evaluate the Feasibility of Ferumoxytol Magnetic Resonance Imaging to Measure Tumor Associated Macrophages and to Predict Patient Response to Treatment | Biotech Hunter | Biotech Hunter