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

Completed · Phase 1

Conditions studied: Solid Tumors, ER/PR Positive Breast Cancer, Triple Negative Breast Cancer, Metastatic Breast Cancer With Active Brain Metastasis

In brief

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.

Key facts

Study ID

NCT01770353

Run by

Ipsen

People needed

45

Starts

2012-11-01

Expected to finish

2018-10-02

Last updated by the study team

2019-11-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All subjects:
• Pathologically confirmed diagnosis of solid tumors
• Metastatic disease
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1
• Adequate bone marrow, hepatic and renal function
• Normal Electrocardiogram (ECG)
• 18 years of age or above
• Able to understand and sign informed consent
• Pilot study only:
• CRC, TNBC, ER/PR Breast Cancer, NSCLC, Pancreatic Cancer, Ovarian Cancer, Gastric Cancer, Gastroesophageal Junction (GEJ) adenocarcinoma, Head and Neck Cancer
• Expansion Phase Additional Criteria:
• Locally advanced or metastatic breast cancer
• Received at least one cytotoxic therapy in the locally advanced and metastatic setting
• Received ≤ 5 prior lines of chemotherapy in the metastatic setting
• Candidate for chemotherapy
• Expansion Phase Cohort 3 additional inclusion criteria:
• Breast cancer with active brain metastasis
• Neurologically stable

You may not qualify if…

• Active Central nervous system (CNS) metastasis (applies to pilot phase and expansion phase cohort 1 and 2 only)
• Clinically significant GI disorders
• Prior irinotecan or bevacizumab therapy within last 6 months and for Expansion Phase patients, have received any prior treatment with Topol inhibitor
• Known hypersensitivity to MM-398 or ferumoxytol
• Inability to undergo MRI
• Active infection
• Pregnant or breast feeding
• Prior chemotherapy administered within 3 weeks, or within a time interval less than at least 5 half-lives of the agent, whichever is longer, prior to the first scheduled day of dosing in this study
• Received radiation therapy in the last 14 days
• Treated with parenteral iron in the previous 4 weeks

Where it is running

• Mayo Clinic — Scottsdale, Arizona, United States
• HonorHealth — Scottsdale, Arizona, United States
• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• University of Michighan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Washington University — St Louis, Missouri, United States
• UNC- Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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