BRAF Inhibitor, LGX818, Utilizing a Pulsatile Schedule in Patients With Stage IV or Unresectable Stage III Melanoma Characterized by a BRAFV600 Mutation

Completed · Phase 2

Conditions studied: Melanoma

In brief

The purpose of this phase II study is to find out if an investigational drug called LGX818 can stop the melanoma from growing.

Key facts

Study ID

NCT01894672

Run by

Memorial Sloan Kettering Cancer Center

People needed

7

Starts

2013-07-01

Expected to finish

2016-03-17

Last updated by the study team

2024-07-16

Who can join

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

You may qualify if…

• Stage IV, or unresectable stage III melanoma that harbors a BRAFV600 mutation
• Any prior therapy allowed except a BRAF or MEK inhibitor,.
• Patients must provide written informed consent prior to any screening procedures.
• Age 18 years or older.
• Willing and able to comply with scheduled visits, treatment plan and laboratory tests
• Patient is able to swallow and retain oral medication
• Measurable disease according to RECIST v1.1
• ECOG performance status ≤ 1

You may not qualify if…

• Brain metastasis or leptomeningeal disease
• Known acute or chronic pancreatitis
• Prior colectomy
• Clinically significant cardiac disease including any of the following:
• CHF requiring treatment (NYHA Classification ≥ 2) in which patients have a history of LVEF < 45% as determined by MUGA scan or ECHO, or uncontrolled hypertension (please refer to WHO-ISH guidelines)
• History or presence of clinically significant ventricular arrhythmias or atrial fibrillation
• Clinically significant resting bradycardia
• Unstable angina pectoris ≤ 3 months prior to starting study drug
• Acute Myocardial Infarction (AMI) ≤ 3 months prior to starting study drug
• QTcF> 480 msec
• Patients with any of the following laboratory values at Screening/baseline:
• Absolute neutrophil count (ANC) <1,500/mm3 [1.5 x 109/L]
• Platelets <100,000/mm3 [100 x 109/L]
• Hemoglobin < 9.0 g/dL
• Serum creatinine>1.5 x ULN
• Serum total bilirubin >1.5 x ULN
• AST/SGOT and/or ALT/SGPT > 2.5 x ULN
• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LGX818 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection).
• Previous or concurrent malignancy. Exceptions: adequately treated basal cell or squamous cell skin cancer; in situ carcinoma of the cervix, treated curatively and without evidence of recurrence for at least 3 years prior to study entry; or other solid tumor treated curatively, and without evidence of recurrence for at least 3 years prior to study entry.
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL).
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, are not allowed to participate in this study UNLESS they are using highly effective methods of contraception throughout the study and for 3 months after study drug discontinuation. Highly effective contraception methods include:
• Total abstinence or
• Male or female sterilization
• Combination of any two of the following (a+b or a+c or b+c)
• Use of oral, injected, or implanted hormonal methods of contraception

Where it is running

• Memorial Sloan Kettering Cancer Center at Basking Ridge — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Cancer Center at Commack — Commack, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Cancer Center at Mercy Medical Center — Rockville Centre, New York, United States
• Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center — Sleepy Hollow, New York, United States

Full record on ClinicalTrials.gov

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