Experimental drug shows promise for rare melanoma type

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 18 years * Unresectable stage III or stage IV melanoma which is histologically confirmed at the treating institution with KIT mutation(s) not known to be resistant to PLX3397 * Presence of measurable lesions by Response Evaluation Criteria in Solid Tumors * Eastern Cooperative Oncology Group (ECOG) performance Status (PS) 0-2 * Life expectancy ≥ 3 months * Adequate organ and bone marrow function * Women of child-bearing potential must have a negative serum pregnancy test at Screening and must agree to use an effective form of contraception from the time of the negative pregnancy test up to 3 months after the last dose of study drug. Women of non-child-bearing potential must have been postmenopausal for ≥ 1 year or surgically sterile. * Fertile men must agree to use an effective method of birth control during the study and for up to 3 months after the last dose of study drug. * Willingness and ability to provide written informed consent prior to any study-related procedures and to comply with all study requirements Exclusion Criteria: * Prior treatment with a KIT inhibitor for melanoma * Presence of NRAS or BRAF mutation * Exposure to any investigational drug within 28 days or unresolved adverse effects from previous therapy * Symptomatic brain metastases. * Active secondary malignancy unless the malignancy is not expected to interfere with the evaluation of safety and is approved by the Sponsor * Concomitant treatment with other anti-neoplastic agents (hormonal therapy acceptable) * Uncontrolled intercurrent or infectious illness * Major surgical procedure or significant traumatic injury within 14 days of initiating study drug or anticipation of the need for major surgery during the study * Previous radiotherapy to 25% or more of the bone marrow and/or radiation therapy within 28 days prior to study entry * Inability to swallow capsules, or refractory nausea and vomiting, malabsorption, an external biliary shunt, or significant bowel resection that would preclude adequate absorption * Congestive heart failure (CHF) New York (NY) Heart Association class III or IV; unstable coronary artery disease \[myocardial infarction (MI) more than 6 months prior to study entry is permitted\] or serious cardiac arrhythmia * Baseline QT interval corrected using Fridericia equation (QTcF) ≥ 450 msec (for males) or ≥ 470 msec (for females) at Screening * Active or chronic infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) * Known chronic liver disease * Women who are breast-feeding or pregnant