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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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

Official Title

A Phase I Study in Patients Treated With MM-398 (Nanoliposomal Irinotecan, Nal-IRI) 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 Breast Neoplasms Triple Negative Breast Neoplasms Irinotecan Camptothecin Ferrosoferric Oxide

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:

  • Cohorts 1 and 2 must be documented to be HER2 negative as outlined in the ASCO/CAP 2013 guidelines for HER2 testing, defined by at least one of the following:
  • HER2 immunohistochemistry (IHC) staining of 0 or 1+,OR if HER2 IHC 2+
  • Negative by In-Situ Hybridization (ISH) based on defined as a Single probe average HER2 copy number <4.0 signals/cell
  • OR Negative by Dual-probe ISH defined as a HER2/CEP17 ratio <2.0 with an average HER2 copy number <4.0 signals/cell
  • 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 locally advanced or metastatic disease with at least two radiologically measurable lesions as defined by RECIST v1.1 (except Expansion Cohort 3)
  • ECOG performance status 0 or 1
  • Bone marrow reserves as evidenced by: ANC > 1,500 cells/μl without the use of hematopoietic growth factors; Platelet count > 100,000 cells/μl; Hemoglobin > 9 g/dL
  • Adequate hepatic function as evidenced by: Normal serum total bilirubin; AST and ALT ≤2.5 x ULN (≤ 5 x ULN is acceptable if liver metastases are present)
  • Adequate renal function as evidenced by serum creatinine ≤ 1.5 x ULN
  • Normal ECG or ECG without any clinically significant findings
  • Recovered from the effects of any prior surgery, radiotherapy or other anti-neoplastic therapy
  • At least 18 years of age
  • Able to understand and sign an informed consent (or have a legal representative who is able to do so)
  • Received at least one cytotoxic therapy in the locally advanced and metastatic setting, with exception of TNBC patients who progressed within 12 months of adjuvant therapy
  • Received 5 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)
  • Candidate for chemotherapy

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)
  • Neurologically stable
  • No evidence of diffuse leptomeningeal disease on brain MRI or by previously documented cerebrospinal fluid (CSF) cytology. NOTE: discrete dural metastases are permitted.

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 and for Expansion Phase patients, have received any prior treatment with Topol inhibitor
  • Known hypersensitivity to MM-398 or ferumoxytol
  • Inability to undergo MRI
  • Active infection
  • Pregnant or breast feeding
  • Prior chemotherapy administered within 3 weeks, or within a time interval less than at least 5 half-lives of the agent, whichever is longer, prior to the first scheduled day of dosing in this study
  • Received radiation therapy in the last 14 days
  • Treated with parenteral iron in the previous 4 weeks

Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center accepting new patients
    San Francisco, California, 94115, United States
  • HonorHealth accepting new patients
    Scottsdale, Arizona, 85258, United States
  • Mayo Clinic accepting new patients
    Scottsdale, Arizona, 85159-5499, United States
  • Washington University not yet accepting patients
    Saint Louis, Missouri, 63110, United States
  • University of Michighan Comprehensive Cancer Center not yet accepting patients
    Ann Arbor, Michigan, 48109, United States
  • Moffitt Cancer Center accepting new patients
    Tampa, Florida, 33607, United States
  • UNC- Lineberger Comprehensive Cancer Center accepting new patients
    Chapel Hill, North Carolina, 27599, United States

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
September 29, 2017
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