LGX818 for Patients With BRAFV600 Mutated Tumors
Status: | Completed |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | January 2014 |
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
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
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Philadelphia, Pennsylvania 19104
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