LGX818 for Patients With BRAFV600 Mutated Tumors (SIGNATURE)

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Solid Tumor; Hematologic Malignancies

Treatments: Drug: LGX818

Study type: Interventional

Funder types: Industry

Identifiers

NCT01981187

CLGX818AUS03

C4221021 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

12 participants in 1 patient group

LGX818

Experimental group

Description:

LGX818 will be dosed on a flat scale of 300 mg (e.g., 3 x 100 mg capsules) once daily on a continuous dosing cycle. A complete treatment cycle is defined as 28 days. There will be no breaks between dosing cycles.

Treatment:

Drug: LGX818