Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 1 of 1 for:    mm-398 ferumoxytol
Previous Study | Return to List | Next Study

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
  Purpose

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.


Condition Intervention Phase
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
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Merrimack Pharmaceuticals:

Primary Outcome Measures:
  • Measure tumor levels of irinotecan and SN-38 (in ng/mL) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 12
Study Start Date: November 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01770353

Contacts
Contact: Eliel Bayever, MD 617-441-1000 ebayever@merrimackpharma.com

Locations
United States, Arizona
Recruiting
Scottsdale, Arizona, United States
Sponsors and Collaborators
Merrimack Pharmaceuticals
Investigators
Study Director: Eliel Bayever, MD Merrimack Pharmaceuticals
  More Information

No publications provided

Responsible Party: Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01770353     History of Changes
Other Study ID Numbers: MM-398-01-01-02
Study First Received: December 19, 2012
Last Updated: August 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merrimack Pharmaceuticals:
MM-398
Ferumoxytol
solid tumors
Triple Negative Breast cancer
Non Small Cell Lung cancer
Colorectal Cancer
nanoliposomal irinotecan
ER/PR positive Breast Cancer
Pancreatic Cancer
Ovarian Cancer
Gastric Cancer
Gastro-Esophageal Junction Adenocarcinoma
Head and Neck Cancer

Additional relevant MeSH terms:
Ferrosoferric Oxide
Adenocarcinoma
Breast Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Esophageal Neoplasms
Head and Neck Neoplasms
Lung Neoplasms
Neoplasms
Ovarian Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Triple Negative Breast Neoplasms
Adnexal Diseases
Breast Diseases
Bronchial Neoplasms
Carcinoma
Carcinoma, Bronchogenic
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Intestinal Diseases

ClinicalTrials.gov processed this record on November 20, 2014