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

• Status: Completed
• Trial end date: 2018-10-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen; Merrimack Pharmaceuticals
• Treatments: Camptothecin; Ferrosoferric Oxide

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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