Evaluation of MM-151 + Nal-IRI + 5-FU + Leucovorin in RAS/RAF Wild-type Metastatic Colorectal Cancer



Status:Recruiting
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/3/2016
Start Date:July 2016
End Date:October 2018
Contact:Sharon Chen
Email:schen@merrimack.com
Phone:(774) 776-1446

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A Phase 1 Study Combining MM-151 + Nal-IRI + 5-FU + Leucovorin in RAS/RAF Wild-type Metastatic Colorectal Cancer

A phase 1b/2a study evaluating the combination of MM-151 + nal-IRI + 5-FU + Leucovorin in
RAS/RAF wild-type Metastatic Colorectal Cancer.

Part 1: Patients will be enrolled to determine the maximum tolerated dose, safety and
tolerability of MM-151 + nal-IRI + 5-FU + LV in patients with mCRC that are RAS/RAF
wild-type.

Part 2: Patients will be enrolled at the maximum tolerated dose of MM-151 in combination
with nal-IRI + 5-FU + LV to characterize initial efficacy in conjunction with levels of
irinotecan and SN-38 measured in tissue.

Inclusion Criteria:

- Patients must be greater than 18 years of age

- Patients must be able to provide informed consent

- Patients must have KRAS/NRAS/BRAF wild-type colorectal cancer

- Willing to abstain from sexual intercourse or to use an effective form of
contraception during the study and for 120 days following the last dose of any study
therapy). This applies to women of childbearing potential as well as fertile men and
their partners

Exclusion Criteria:

- Patients who have had previous pelvic radiation treatment

- Patients who are pregnant or lactating

- Patients who have untreated (primary) or uncontrolled Central Nervous System (CNS)
(primary or metastatic) malignancies; patients with CNS metastases who have undergone
surgery or radiotherapy or who have been on a stable dose of corticosteroids for at
least 2 weeks and whose disease is stable prior to the first scheduled day of dosing
will be eligible for the trial.

- History of any second malignancy in the last 3 years; patients with prior history of
in-situ cancer or basal or squamous cell skin cancer are eligible.

- Patients who have received other recent antitumor therapy including any standard
chemotherapy or radiation within 14 days and bevacizumab within 28 days (and having
passed the time of any actual or anticipated toxicities) prior to the first scheduled
dose of the study treatment
We found this trial at
7
sites
Salt Lake City, Utah 84112
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2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Phone: 800-811-8480
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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Avondale, Arizona 85323
Phone: 424-208-8866
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Avondale, AZ
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Jacksonville, Florida 32224
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Jacksonville, FL
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Lafayette, Indiana 47905
Phone: 765-446-5111
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Lafayette, IN
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Lebanon, NH
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Tacoma, Washington 98405
Phone: 424-208-8866
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Tacoma, WA
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