LGX818 for Patients With BRAFV600 Mutated Tumors



Status:Completed
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:January 2014

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Modular Phase II Study to Link Targeted Therapy to Patients With Pathway Activated Tumors: Module 4 - LGX818 for Patients With BRAFV600 Mutated Tumors

The purpose of this signal seeking study is to determine whether treatment with LGX818
demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic
malignancies to warrant further study


Inclusion Criteria

- Patient has a confirmed diagnosis of a select solid tumor (except with a primary
diagnosis of melanoma and colorectal cancer (CRC)) or hematologic malignancies and is
in need of treatment because of progression or relapse.

- Patient's tumor has been evaluated and pre-identified as having a tumor with a
BRAFV600 mutation at a CLIA certified laboratory.

- Patient must have received at least one prior treatment for recurrent, metastatic and
/or locally advanced disease and for whom no standard therapy options are anticipated
to result in a durable remission.

- Patient must have progressive and measurable disease per RECIST 1.1. or other
appropriate hematological response criteria.

- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

Exclusion Criteria:

- Patient has received prior treatment with LGX818.

- Patients with Central Nerve System (CNS) metastasis or leptomeningeal carcinomatosis.

- Patient has received chemotherapy or other anticancer therapy ≤ 4 weeks (6 weeks for
nitrosourea, antibodies or mitomycin-C) prior to starting study drug.

- Patients with acute or chronic pancreatitis.

- Patients with impaired cardiac function or clinically significant cardiac diseases.

- Patients with another primary malignancy within 3 years prior to starting study
treatment, with the exception of adequately treated basal cell carcinoma, squamous
cell carcinoma or other non-melanomatous skin cancer, or in-situ carcinoma of the
uterine cervix.
We found this trial at
13
sites
Sioux Falls, South Dakota 57104
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Birmingham, Alabama 35211
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Birmingham, AL
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Chicago, IL
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Fayetteville, AR
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Fort Myers, FL
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Houston, TX
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Las Vegas, NV
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New Haven, CT
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Norwalk, CT
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Philadelphia, PA
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Salt Lake City, UT
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Winchester, Virginia 22601
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Winchester, VA
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Zanesville, Ohio 43701
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Zanesville, OH
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