Overview

This trial is active, not recruiting.

Condition solid tumor and hematologic malignancies
Treatment lgx818
Phase phase 2
Targets RAF, BRAF
Sponsor Array BioPharma
Start date January 2014
End date September 2017
Trial size 12 participants
Trial identifier NCT01981187, CLGX818AUS03

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
lgx818
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.

Primary Outcomes

Measure
Clinical benefit rate associated with LGX818 treatment
time frame: 16 weeks

Secondary Outcomes

Measure
Overall Response (OR) or Partial Response (PR) or greater
time frame: baseline and every 8 weeks until disease progression or end of treatment, assessed up to 24 months
Progression-Free Survival
time frame: every 8 weeks until death, assessed up to 24 months
Overall survival
time frame: every 8 weeks until death, assessed up to 36 months
Duration of Response
time frame: baseline and every 8 weeks until disease progression or end of treatment, assessed up to 24 months
Number of participants with adverse events as a measure of Safety and Tolerability
time frame: baseline and every 8 weeks until disease progression or end of treatment, assessed up to 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Modular Phase II Study to Link Targeted Therapy to Patients With Pathway Activated Tumors: Module 4 - LGX818 for Patients With BRAFV600 Mutated Tumors
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Array BioPharma.