Skip to main content
Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

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.

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 and to Predict Patient Response to Treatment

Details

This study is conducted over two phases. The pilot phase of this trial is closed. The expansion phase of this trial is currently open to enrollment.

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 NSCLC, CRC, TNBC, 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:

Cohort 1: ER and/or PR-positive breast cancer Cohort 2: TNBC Cohort 3: BC with active brain metastasis

Keywords

Solid Tumors ER/PR Positive Breast Cancer Triple Negative Breast Cancer Metastatic Breast Cancer With Active Brain Metastasis Colorectal Cancer MM-398 nanoliposomal irinotecan Ferumoxytol Pancreatic Cancer Ovarian Cancer Gastric Cancer Gastro-Esophageal Junction Adenocarcinoma Head and Neck Cancer TNBC Ferrosoferric Oxide Camptothecin

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

Expansion Phase Additional Criteria:

The following invasive breast cancer tumor sub-types are required:

  • Cohort 1: hormone receptor positive breast cancer patients with ER-positive and/or PR-positive tumors defined as ≥1% of tumor nuclei that are immunoreactive for ER and/or PR and HER2 negative
  • Cohort 2: triple negative breast cancer (TNBC) patients with ER-negative, PR-negative tumors defined as < 1% of tumor nuclei that are immunoreactive for ER and PR and HER2 negative
  • Cohort 3: Any sub-type of metastatic breast cancer and active brain metastases
  • Documented metastatic disease with at least two radiologically measurable lesions as defined by RECIST v1.1 (except Cohort 3, see inclusion criterion o below)
  • Received at least one cytotoxic therapy in the metastatic setting, with exception of TNBC patients who progressed within 12 months of adjuvant therapy
  • Received ≤ 3 prior lines of chemotherapy in the metastatic setting (no limit to prior lines of hormonal therapy in Cohort 1)
  • At least one lesion amenable to multiple pass core biopsy (exception: Cohort 3 patients)

Expansion Phase Cohort 3 additional inclusion criteria:

  • Radiographic evidence of new or progressive brain metastases after prior radiation therapy with at least one brain metastasis measuring ≥ 1 cm in longest diameter on gadolinium-enhanced MRI (note: progressive brain lesions are not required to meet RECIST criteria in order to be eligible; extra-cranial metastatic disease is also allowed)

You CAN'T join if...

  • Active 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
  • Known hypersensitivity to MM-398 or ferumoxytol
  • Inability to undergo MRI
  • Active infection
  • Pregnant or breast feeding

Locations

  • Mayo Clinic not yet accepting patients
    Scottsdale, Arizona, 85159, USA
  • HonorHealth accepting new patients
    Scottsdale, Arizona, 85258, USA
  • Moffitt Cancer Center accepting new patients
    Tampa, Florida, 33607, USA
  • University of Michighan Comprehensive Cancer Center not yet accepting patients
    Ann Arbor, Michigan, 48109, USA
  • Washington University not yet accepting patients
    Saint Louis, Missouri, 63110, USA
  • UNC- Lineberger Comprehensive Cancer Center accepting new patients
    Chapel Hill, North Carolina, 27599, USA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Ipsen
ID
NCT01770353
Phase
Phase 1
Lead Scientist
Pamela Munster
Study Type
Interventional
Last Updated
April 2017
I'm interested in this study!