Trial record 1 of 2 for:    mm-398 ferumoxytol
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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 July 2016 by Merrimack Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01770353
First received: December 19, 2012
Last updated: July 7, 2016
Last verified: July 2016

December 19, 2012
July 7, 2016
November 2012
June 2017   (final data collection date for primary outcome measure)
Measure tumor levels of irinotecan and SN-38 (in ng/mL) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01770353 on ClinicalTrials.gov Archive Site
  • 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
  • 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 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 availabilty 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
Not Provided
Not Provided
 
Pilot Study to Determine Biodistribution of MM-398 and Feasibility of Ferumoxytol as a Tumor Imaging Agent
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
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.

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

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
  • Solid Tumors
  • ER/PR Positive Breast Cancer
  • Triple Negative Breast Cancer
  • Metastatic Breast Cancer With Active Brain Metastasis
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
  • Experimental: Pilot Phase: Ferumoxytol followed by MM-398 (CLOSED)
    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 week cycle
    Intervention: Drug: Ferumoxytol followed by MM-398
  • Experimental: Expansion Phase: 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 week cycle Cohort 1: ER and/or PR-positive BC Cohort 2: TNBC Cohort 3: BC with active brain metastasis
    Intervention: Drug: Ferumoxytol followed by MM-398
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
October 2017
June 2017   (final data collection date for primary outcome measure)

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

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)

Exclusion Criteria:

  • 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
Both
18 Years and older   (Adult, Senior)
No
Contact: Istvan Molnar, MD 617-441-1000 ext 7649 imolnar@merrimack.com
United States
 
NCT01770353
MM-398-01-01-02
No
Not Provided
Not Provided
Merrimack Pharmaceuticals
Merrimack Pharmaceuticals
Not Provided
Study Director: Istvan Molnar, MD Merrimack Pharmaceuticals
Merrimack Pharmaceuticals
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP