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 @ 7:45 PM
Ignite Modification Date:
2025-12-24 @ 7:45 PM
NCT ID:
NCT01271803
Eligibility Criteria:
Inclusion Criteria:
* Participants with histologically confirmed melanoma (unresectable Stage IIIc and Stage IV metastatic melanoma, as defined by American Joint Committee on Cancer \[AJCC\])
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version (V) 1.1
* Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to (\</=) 1
* Participants must
1. be previously untreated for locally advanced/unresectable or metastatic melanoma or
2. previously treated but without prior exposure to any BRAF or MEK inhibitor therapy or
3. progressed on vemurafenib while participating in a Phase I (including clinical pharmacology studies), II, or III clinical study or expanded access programs (EAP) immediately prior to enrollment in this study or
4. progressed on vemurafenib administered in a postmarketing setting immediately prior to enrollment in this study.
* Life expectancy \>/=12 weeks
Exclusion Criteria:
* History of prior significant toxicity from another RAF or MEK pathway inhibitor requiring discontinuation of treatment
* Palliative radiotherapy within 2 weeks prior to first dose of study drug treatment
* Experimental therapy within 4 weeks prior to first dose of study drug treatment except vemurafenib
* Major surgery within 4 weeks of first dose of study drug treatment or planning a major surgery during the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01271803
Study Brief:
Protocol Section:
NCT01271803