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
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01770353 |
Recruitment Status
:
Active, not recruiting
First Posted
: January 17, 2013
Last Update Posted
: January 30, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Solid Tumors ER/PR Positive Breast Cancer Triple Negative Breast Cancer Metastatic Breast Cancer With Active Brain Metastasis | Drug: Ferumoxytol followed by MM-398 | Phase 1 |
This study is conducted over two phases. The pilot phase of this trial is closed. The expansion phase of this trial has completed enrolment, patients are still ongoing.
Pilot Phase: This study will enroll approximately 12 patients, up to 20 in total in the Pilot Phase and 30 patients in the Expansion Phase. The first three patients that are enrolled can have any solid tumor type; however subsequent patients must have Non-small cell lung cancer (NSCLC), Colorectal cancer (CRC), Triple negative breast cancer (TNBC), Estrogen Receptor/Progesterone Receptor (ER/PR) positive breast cancer, pancreatic cancer, ovarian cancer, gastric cancer, gastro-oesophageal junction adenocarcinoma or head and neck cancer. No more than three patients with ER/PR positive breast cancer can be enrolled in the Pilot Phase and similar restrictions may be placed on other tumor types to ensure a heterogeneous population.
Expansion Phase: The expansion will enroll patients with advanced metastatic breast cancer into three cohorts of 10 patients each depending on sub-type of breast cancer:
Cohort 1: ER and/or PR-positive breast cancer Cohort 2: TNBC Cohort 3: BC with active brain metastasis
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 45 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | 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 |
Study Start Date : | November 2012 |
Estimated Primary Completion Date : | June 2018 |
Estimated Study Completion Date : | June 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Pilot Phase: Ferumoxytol followed by MM-398 (CLOSED)
Ferumoxytol 5 mg/kg IV at the rate of 1 mL/sec, given once on Day 1. MM-398 80 mg/m2 IV over 90 min on Days 1 and 15 of every 4 week cycle
|
Drug: Ferumoxytol followed by MM-398
Ferumoxytol 5 mg/kg IV at 1mL/sec, given once. MM-398 80 mg/m2 IV over 90 min every 2 weeks, until progressive disease or intolerable toxicity
|
Experimental: Expansion Phase: Ferumoxytol followed by MM-398
Ferumoxytol 5 mg/kg IV at the rate of 1 mL/sec, given once on Day 1. MM-398 80 mg/m2 IV over 90 min on Days 1 and 15 of every 4 week cycle Cohort 1: ER and/or PR-positive BC Cohort 2: TNBC Cohort 3: BC with active brain metastasis
|
Drug: Ferumoxytol followed by MM-398
Ferumoxytol 5 mg/kg IV at 1mL/sec, given once. MM-398 80 mg/m2 IV over 90 min every 2 weeks, until progressive disease or intolerable toxicity
|
- Measure tumor levels of irinotecan and SN-38 (in ng/mL) [ Time Frame: 12 months ]
- Safety profile of MM-398 in the presence of ferumoxytol (number and type of Adverse Events compared with histological control) [ Time Frame: 12 months ]
- Tumor response Rate measured by RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 guidelines [ Time Frame: 12 months ]
- Half-life of the drug (t 1/2) in number of hours [ Time Frame: 12 months ]50% of total time of drug in plasma
- Maximum concentration of drug in plasma (Cmax) in ng/mL [ Time Frame: 12 months ]
- Measure of drug availability in the plasma (AUC) in ng/mL x hours [ Time Frame: 12 months ]Area under the plasma drug concentration versus time curve

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01770353
United States, Arizona | |
Mayo Clinic | |
Scottsdale, Arizona, United States, 85159-5499 | |
HonorHealth | |
Scottsdale, Arizona, United States, 85258 | |
United States, California | |
UCSF Helen Diller Family Comprehensive Cancer Center | |
San Francisco, California, United States, 94115 | |
United States, Florida | |
Moffitt Cancer Center | |
Tampa, Florida, United States, 33607 | |
United States, Michigan | |
University of Michighan Comprehensive Cancer Center | |
Ann Arbor, Michigan, United States, 48109 | |
United States, Missouri | |
Washington University | |
Saint Louis, Missouri, United States, 63110 | |
United States, North Carolina | |
UNC- Lineberger Comprehensive Cancer Center | |
Chapel Hill, North Carolina, United States, 27599 |
Study Director: | Navreet Dhindsa | Ipsen |
Responsible Party: | Ipsen |
ClinicalTrials.gov Identifier: | NCT01770353 History of Changes |
Other Study ID Numbers: |
MM-398-01-01-02 |
First Posted: | January 17, 2013 Key Record Dates |
Last Update Posted: | January 30, 2018 |
Last Verified: | January 2018 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Keywords provided by Ipsen:
solid tumors Triple Negative Breast Cancer Colorectal Cancer MM-398 nanoliposomal irinotecan Ferumoxytol ER/PR positive Breast Cancer |
Pancreatic Cancer Ovarian Cancer Gastric Cancer Gastro-Esophageal Junction Adenocarcinoma Head and Neck Cancer TNBC |
Additional relevant MeSH terms:
Breast Neoplasms Triple Negative Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Irinotecan Camptothecin Ferrosoferric Oxide |
Antineoplastic Agents, Phytogenic Antineoplastic Agents Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Hematinics Parenteral Nutrition Solutions Pharmaceutical Solutions |