This study is an open-label, dose-escalation study of MM-111 with five different combination treatments with the main goal of determining the safety of MM-111 with each combination.
To determine the MTD and any DLT of MM 111 when administered in combination with either 1) cisplatin, capecitabine, and trastuzumab; 2) lapatinib +/- trastuzumab; 3) paclitaxel and trastuzumab 4) lapatinib, paclitaxel and trastuzumab or 5) docetaxel and trastuzumab in patients with human epidermal growth factor receptor (HER2+) solid tumors
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Conventional chemotherapy
Conventional chemotherapy
Conventional chemotherapy
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Georgia Cancer Specialists
Atlanta, Georgia, United States
Determine patient's safety (# of adverse events/serious adverse events) and tolerability of MM-111 in combination with multiple treatment regimens
To determine the maximum tolerated dose (MTD) and any dose limiting toxicity (DLT) of MM-111 when administered in combination with either 1. cisplatin, capecitabine, and trastuzumab; 2. lapatinib +/- trastuzumab; 3. paclitaxel and trastuzumab 4. lapatinib, paclitaxel, trastuzumab; or 5. docetaxel and trastuzumab in patients with HER 2 positive solid tumors
Time frame: 30 months
To characterize the pharmacokinetics (PK) profile of MM-111 when administered in combination with multiple treatment regimens. The PK profile will help to determine the phase 2 dose
Treatment regimens include either: 1. cisplatin, capecitabine, and trastuzumab; 2. lapatinib +/- trastuzumab; 3. paclitaxel and trastuzumab; 4. lapatinib, paclitaxel, trastuzumab; or 5. docetaxel and trastuzumab in patients with HER2+ solid tumors.
Time frame: 33 months
To establish the recommended Phase 2 dose(s) of MM-111 when administered in each of the combinations assessed (based on PK profile, safety data and overall patient tolerability)
Time frame: 33 months
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Conventional chemo
Conventional chemotherapy
Central Indiana Cancer Centers
Indianapolis, Indiana, United States
Horizon Oncology Research, Inc
Lafayette, Indiana, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
New York Oncology/Hematology
Albany, New York, United States
Innovation Center - Kettering Medical Center Health Network
Kettering, Ohio, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
GHS Institute of Transitional Oncology Research
Greenville, South Carolina, United States
Texas Oncology Cancer Center
Austin, Texas, United States
...and 5 more locations