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Trial record 1 of 1 for:    mm-398 ferumoxytol
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Pilot Study to Determine Biodistribution of MM-398 and Feasibility of Ferumoxytol as a Tumor Imaging Agent

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Merrimack Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01770353
First received: December 19, 2012
Last updated: August 8, 2013
Last verified: August 2013

December 19, 2012
August 8, 2013
November 2012
November 2013   (final data collection date for primary outcome measure)
Measure tumor levels of irinotecan and SN-38 (in ng/mL) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Tumor response Rate measured by RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 guidelines [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Half-life of the drug (t 1/2) in number of hours [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    50% of total time of drug in plasma
  • Maximum concentration of drug in plasma (Cmax) in ng/mL [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Measure of drug availability in the plasma (AUC) in ng/mL x hours [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Tumor response Rate measured by RECIST 1.1 guidelines [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Half-life of the drug (t 1/2) in number of hours [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    50% of total time of drug in plasma
  • Maximum concentration of drug in plasma (Cmax) in ng/mL [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Measure of drug availabilty in the plasma (AUC) in ng/mL x hours [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Area under the plasma drug concentration versus time curve
Not Provided
Not Provided
 
Pilot Study to Determine Biodistribution of MM-398 and Feasibility of Ferumoxytol as a Tumor Imaging Agent
A Pilot Study in Patients Treated With MM-398 to Determine Tumor Drug Levels and to Evaluate the Feasibility of Ferumoxytol Magnetic Resonance Imaging to Measure Tumor Associated Macrophages

This is a Phase I Pilot study to understand the biodistribution of MM-398 and to determine the feasibility of using Ferumoxytol as a tumor imaging agent.

Not Provided
Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
  • Solid Tumors
  • Triple Negative Breast Cancer
  • Non Small Cell Lung Cancer
  • Colorectal Cancer
  • ER/PR Positive Breast Cancer
  • Pancreatic Cancer
  • Ovarian Cancer
  • Gastric Cancer
  • Gastro-Esophageal Junction Adenocarcinoma
  • Head and Neck Cancer
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: 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 weekly cycle
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.
 
Recruiting
12
November 2013
November 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pathologically confirmed diagnosis of solid tumors, CRC, TNBC, ER/PR Breast Cancer, NSCLC, Pancreatic Cancer, Ovarian Cancer, Gastric Cancer, GEJ adenocarcinoma, Head and Neck Cancer
  • Metastatic disease
  • ECOG Performance Status 0 to 2
  • Adequate bone marrow, hepatic and renal function
  • Normal ECG
  • 18 years of age or above
  • Able to understand and sign informed consent

Exclusion Criteria:

  • Active CNS metastasis
  • Clinically significant GI disorders
  • Prior irinotecan or bevacizumab therapy within last 6 months
  • Known hypersensitivity to MM-398 or ferumoxytol
  • Inability to undergo MRI
  • Active infection
  • Pregnant or breast feeding
Both
18 Years and older
No
Contact: Eliel Bayever, MD 617-441-1000 ebayever@merrimackpharma.com
United States
 
NCT01770353
MM-398-01-01-02
No
Merrimack Pharmaceuticals
Merrimack Pharmaceuticals
Not Provided
Study Director: Eliel Bayever, MD Merrimack Pharmaceuticals
Merrimack Pharmaceuticals
August 2013

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