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LGX818 for Patients With BRAFV600 Mutated Tumors (SIGNATURE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01981187
Recruitment Status : Completed
First Posted : November 11, 2013
Last Update Posted : April 29, 2016
Sponsor:
Information provided by (Responsible Party):
Array BioPharma

Brief 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

Condition or disease Intervention/treatment Phase
Solid Tumor Hematologic Malignancies Drug: LGX818 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2014
Actual Primary Completion Date : September 2015

Arm Intervention/treatment
Experimental: 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.
Drug: 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 Outcome Measures :
  1. Clinical benefit rate associated with LGX818 treatment [ Time Frame: 16 weeks ]
    Clinical benefit rate for patients with solid tumors will be assessed using RECIST 1.1 and will include responses of CR or PR or SD. For hematologic tumors other appropriate hematological response criteria will apply


Secondary Outcome Measures :
  1. 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 ]
    Overall Response (OR) of Partial Response (PR) or greater based on local investigator assessment. For patients with solid tumors the assessment criteria will be RECIST 1.1 and will include responses of CR and/or PR. For hematologic tumors other appropriate hematological response criteria will apply

  2. Progression-Free Survival [ Time Frame: every 8 weeks until death, assessed up to 24 months ]
    Progression free survival (PFS) is defined as the time from the date of first dose to the date of first documented disease progression or relapse or death due to any cause

  3. Overall survival [ Time Frame: every 8 weeks until death, assessed up to 36 months ]
    Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause

  4. Duration of Response [ Time Frame: baseline and every 8 weeks until disease progression or end of treatment, assessed up to 24 months ]
    The duration of response (PR or greater) applies only to patients whose best response was PR or greater. It is defined as the time from the first documented response to the date first documented disease progression or relapse or death due to any cause

  5. 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 ]
    Safety and tolerability will be will be based on the frequency of adverse events and on the number of laboratory values that fall outside of pre-determined ranges. Other safety data (e.g., electrocardiogram, vital signs) will be considered as appropriate.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01981187


Locations
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United States, Alabama
Alabama Oncology St. Vincent's Birmingham
Birmingham, Alabama, United States, 35211
United States, Arkansas
Highlands Oncology Group Highlands Oncology Group (22)
Fayetteville, Arkansas, United States, 72703
United States, Connecticut
Yale University School of Medicine Smilow Cancer Hospital
New Haven, Connecticut, United States, 06520
Whittingham Cancer Center Norwalk Hospital
Norwalk, Connecticut, United States, 06856
United States, Florida
Florida Cancer Specialists Florida Cancer Specialists (31
Fort Myers, Florida, United States, 33901
United States, Illinois
Lurie Children's Hospital of Chicago Developmental Therapeutics
Chicago, Illinois, United States, 60611
United States, Nevada
Comprehensive Cancer Centers of Nevada CCC of Nevada (1)
Las Vegas, Nevada, United States, 89109
United States, Ohio
Genesis Cancer Services
Zanesville, Ohio, United States, 43701
United States, Pennsylvania
University of Pennsylvania Presbyterian Medical Center University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, South Dakota
Sanford Research Sanford Health
Sioux Falls, South Dakota, United States, 57104
United States, Texas
Oncology Consultants Oncology Group
Houston, Texas, United States, 77024
United States, Utah
Utah Cancer Specialists Utah Cancer Specialists (11)
Salt Lake City, Utah, United States, 84106
United States, Virginia
Shenandoah Oncology Shenadoah Oncology (2)
Winchester, Virginia, United States, 22601
Sponsors and Collaborators
Array BioPharma
Investigators
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Study Director: Array BioPharma 303-381-6604
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Responsible Party: Array BioPharma
ClinicalTrials.gov Identifier: NCT01981187    
Other Study ID Numbers: CLGX818AUS03
First Posted: November 11, 2013    Key Record Dates
Last Update Posted: April 29, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms
Neoplasms by Site
Hematologic Diseases