Pilot Study to Determine Biodistribution of MM-398 and Feasibility of Ferumoxytol as a Tumor Imaging Agent
Conditions
Solid Tumors - Triple Negative Breast Cancer - ER/PR Positive Breast Cancer - Metastatic Breast Cancer With Active Brain Metastasis
Conditions: official terms
Breast Neoplasms - Triple Negative Breast Neoplasms
Conditions: Keywords
solid tumors, Triple Negative Breast 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
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
Intervention
Name: Ferumoxytol followed by MM-398
Type: Drug
Overall Status
Recruiting
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.
Detailed Description
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 cohorts of single indications of patients with metastatic breast cancer in 3 cohorts:

Cohort 1: ER and/or PR-positive breast cancer Cohort 2: TNBC Cohort 3: BC with active brain metastasis
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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

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
Location
Scottsdale, Arizona, United States
Status: Recruiting
Start Date
November 2012
Completion Date
March 2016
Sponsors
Merrimack Pharmaceuticals
Source
Merrimack Pharmaceuticals
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page