Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-24 @ 10:32 PM
NCT ID:
NCT02300935
Eligibility Criteria:
Inclusion Criteria:
* Adults (≥18 years) with histologically or cytologically-confirmed advanced unresectable or metastatic melanoma. BRAF mutation-positive and wild-type tumors are allowed.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate hematologic, renal, and hepatic function
* Life expectancy ≥12 weeks
* Any pre-existing neuropathy must be \<grade 2 per Common Technology Criteria for Adverse Events (CTCAE) version 4.0
Exclusion Criteria:
* More than 1 prior cytotoxic chemotherapy regimen in the metastatic setting
* Prior MEK inhibitor therapy (prior BRAF inhibitor allowed)
* Prior nab-paclitaxel (prior taxane allowed)
* Use of an investigational anti-cancer drug within 21 days or 5 half-lives (whichever is shorter) prior to first dose. A minimum of 10 days after termination of investigational drug is required. Any drug-related toxicity should have resolved to Grade 1 or baseline.
* Symptomatic or untreated brain metastases
* History of retinal vein occlusion (RVO)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02300935
Study Brief:
Protocol Section:
NCT02300935