At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 45 enrolled
Drug / intervention
Ferumoxytol +1 moredrug
Likely dose
Ferumoxytol 5 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I Study in Patients Treated With 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
In Brief
A Phase 1 clinical trial evaluating Ferumoxytol and MM-398 for Solid Tumors and 3 related conditions. Completed, enrolled 45 participants across 7 sites.
Detailed Summary
This is a Phase I study to understand the biodistribution of MM-398 and to determine the feasibility of using Ferumoxytol as a tumor imaging agent.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumors, ER/PR Positive Breast Cancer, Triple Negative Breast Cancer, Metastatic Breast Cancer With Active Brain Metastasis
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2012
First PostedJan 2013
Primary CompletionOct 2018
TodayJul 2026
First PostedJan 17, 2013
Enrollment StartNov 1, 2012
Primary CompletionOct 2, 2018
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 13.5 years ago
Interventions
Ferumoxytoldrug
Ferumoxytol 5 mg/kg IV as a single bolus injection, given once.
MM-398drug
MM-398 IV over 90 min every 2 weeks, until progressive disease or intolerable toxicity