Clinical Trial Details
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NCT03332589 : Study of E6201 for the Treatment of Central Nervous System Metastases (CNS)
PhasePhase 1
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Males and females = 18 years of age

- Histologically or cytologically confirmed BRAF- or MEK-mutated melanoma

- BRAF- or MEK-mutation melanoma tumor status will be established prior to entry based
on previous BRAF-gene analysis or MEK pathway mutation reports from a CLIA qualified
laboratory. If a report is not available, the mutation analysis will be performed at
Screening on archival tissue

- Documented metastasis of the primary tumor to the CNS and not a candidate for surgical
intervention nor require immediate radiation therapy to relieve symptoms

- Other metastatic melanoma systemic disease allowed

- Minimum intervals required to be off treatment prior to Cycle 1 Day 1:

- Prior radiotherapy (RT) to current field of CNS disease = 4 weeks

- Nitrosourea cytotoxic drug = 6 weeks

- Non-nitrosourea cytotoxic drug or any systemic investigational agent with
exception of methotrexate = 4 weeks

- Approved PD-1/PD-L1 inhibitors, CTLA4 checkpoint inhibitors, or other
immunotherapy = 4 weeks

- Approved BRAF and MEK inhibitors = 3 weeks

- Methotrexate or non-BRAF/MEK non-cytotoxic anti-tumor drug = 2 weeks

- Radiographically measurable disease in the CNS documented = 3 weeks prior to starting
E6201 treatment

- Asymptomatic or symptomatic CNS metastasis allowed

- Previously-treated or untreated CNS metastasis allowed

- Stable dose of corticosteroids for CNS metastasis for > 7 days

- Patients with seizures due to CNS metastases must be controlled with stable
anti-epileptic treatment for > 14 days

- Prior treatment with 1 BRAF inhibitor and/or 1 MEK inhibitor allowed

- Bisphosphonates and/or denosumab are allowed

- Adequate performance status: Eastern Cooperative Oncology Group (ECOG) = 2

- Life expectancy of = 3 months

- Adequate hematologic parameters without ongoing transfusional support:

- Hemoglobin (Hb) = 9 g/dL

- Absolute neutrophil count (ANC) = 1.0 x 109 cells/L

- Platelets = 75 x 109 cells/L

- Adequate renal and hepatic function:

- Creatinine = 1.5 x the upper limit of normal (ULN), or calculated creatinine
clearance = 50 mL/minute x 1.73 m2 per the Cockcroft-Gault formula

- Total bilirubin = 2 times the upper limit of normal (ULN) unless due to Gilbert's

- ALT/AST = 2.5 times ULN, or < 5 times ULN for subjects with liver metastases

- Negative serum pregnancy test within 14 days prior to the first dose of study therapy
for women of child-bearing potential (WCBP), defined as a sexually mature woman who
has not undergone a hysterectomy or who has not been naturally post-menopausal for at
least 24 consecutive months (i.e., who has had menses any time in the preceding 24
consecutive months). Sexually active WCBP and male subjects must agree to use adequate
methods to avoid pregnancy (oral, injectable, or implantable hormonal contraceptive;
tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or
vasectomized partner) throughout the study and for 28 days after the completion of
study treatment.

- Ability to provide written informed consent

Exclusion Criteria:

- Urgent need of treatment to prevent acute neurologic deterioration, including urgent
neurosurgery or radiotherapy

- Symptoms of uncontrolled intracranial pressure

- Evidence of leptomeningeal metastases

- Symptomatic or untreated spinal cord compression

- Serious cardiac condition within the last 6 months, such as uncontrolled arrhythmia,
myocardial infarction, unstable angina or heart disease defined by the New York Heart
Association (NYHA) Class III or Class IV

- QT interval corrected for rate (QTc) > 480 msec for on the ECG obtained at Screening
using Fridericia method for QTc calculation

- Known positive for human immunodeficiency virus (HIV), hepatitis B virus surface
antigen (HBsAg) or hepatitis C virus (HCV)

- Active infection requiring IV antibiotic usage within the last week prior to study

- Any other medical intervention or other condition which, in the opinion of the
Principal Investigator, could compromise adherence to study requirements or confound
the interpretation of study results

- Pregnant or breast-feeding
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