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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Solid Tumors, Triple Negative Breast Cancer, Non Small Cell Lung Cancer, Colorectal Cancer

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Trial Information

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


Inclusion Criteria:



- Pathologically confirmed diagnosis of solid tumors, CRC, TNBC and NSCLC

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Measure tumor levels of irinotecan and SN-38 (in ng/mL)

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Eliel Bayever, MD

Investigator Role:

Study Director

Investigator Affiliation:

Merrimack Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

MM-398-01-01-02

NCT ID:

NCT01770353

Start Date:

November 2012

Completion Date:

November 2013

Related Keywords:

  • Solid Tumors
  • Triple Negative Breast Cancer
  • Non Small Cell Lung Cancer
  • Colorectal Cancer
  • solid tumors
  • Triple Negative Breast cancer
  • Non Small Cell Lung cancer
  • Colorectal Cancer
  • MM-398
  • nanoliposomal irinotecan
  • Ferumoxytol
  • Breast Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Colorectal Neoplasms
  • Lung Neoplasms

Name

Location
Phoenix, Arizona  85012