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

History of Changes

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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Colorectal Cancer Head and Neck Cancer Lung Cancer Ovarian Cancer Pancreatic Cancer Stomach Cancer

Drug Information available for: Ferumoxytol

Genetic and Rare Diseases Information Center resources: Esophageal Cancer Ovarian Cancer Pancreatic Cancer Stomach Carcinoma

U.S. FDA Resources

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:


solid tumors Triple Negative Breast cancer Non Small Cell Lung 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

Additional relevant MeSH terms:


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 Intestinal Neoplasms

ClinicalTrials.gov processed this record on February 25, 2015

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