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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

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ClinicalTrials.gov Identifier: NCT01770353
Recruitment Status : Active, not recruiting
First Posted : January 17, 2013
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Ipsen

December 19, 2012
January 17, 2013
January 30, 2018
November 2012
June 2018   (Final data collection date for primary outcome measure)
Measure tumor levels of irinotecan and SN-38 (in ng/mL) [ Time Frame: 12 months ]
Same as current
Complete list of historical versions of study NCT01770353 on ClinicalTrials.gov Archive Site
  • 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
  • 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 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 availabilty in the plasma (AUC) in ng/mL x hours [ Time Frame: 12 months ]
    Area under the plasma drug concentration versus time curve
Not Provided
Not Provided
 
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
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
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.

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

Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
  • Solid Tumors
  • ER/PR Positive Breast Cancer
  • Triple Negative Breast Cancer
  • Metastatic Breast Cancer 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
  • 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
    Intervention: Drug: Ferumoxytol followed by MM-398
  • 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
    Intervention: Drug: Ferumoxytol followed by MM-398
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
45
12
June 2018
June 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01770353
MM-398-01-01-02
No
Studies a U.S. FDA-regulated Drug Product: Yes
Not Provided
Ipsen
Ipsen
Not Provided
Study Director: Navreet Dhindsa Ipsen
Ipsen
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP