LGX818 for Patients With BRAFV600 Mutated Tumors

Stopped early · Phase 2

Conditions studied: Solid Tumor, Hematologic Malignancies

In brief

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

Key facts

Study ID

NCT01981187

Run by

Pfizer

People needed

12

Starts

2014-01-14

Expected to finish

2015-10-13

Last updated by the study team

2021-03-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Alabama Oncology St. Vincent's Birmingham — Birmingham, Alabama, United States
• Highlands Oncology Group Highlands Oncology Group (22) — Fayetteville, Arkansas, United States
• Yale University School of Medicine Smilow Cancer Hospital — New Haven, Connecticut, United States
• Whittingham Cancer Center Norwalk Hospital — Norwalk, Connecticut, United States
• Florida Cancer Specialists Florida Cancer Specialists (31 — Fort Myers, Florida, United States
• Lurie Children's Hospital of Chicago Developmental Therapeutics — Chicago, Illinois, United States
• Comprehensive Cancer Centers of Nevada CCC of Nevada (1) — Las Vegas, Nevada, United States
• Genesis Cancer Services — Zanesville, Ohio, United States
• University of Pennsylvania Presbyterian Medical Center University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Sanford Research Sanford Health — Sioux Falls, South Dakota, United States
• Oncology Consultants Oncology Group — Houston, Texas, United States
• Utah Cancer Specialists Utah Cancer Specialists (11) — Salt Lake City, Utah, United States
• Shenandoah Oncology Shenadoah Oncology (2) — Winchester, Virginia, United States

Full record on ClinicalTrials.gov

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