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 @ 4:23 PM
Ignite Modification Date:
2025-12-24 @ 4:23 PM
NCT ID:
NCT01849666
Eligibility Criteria:
Inclusion Criteria:
* Adult patients, 18-70 years of age
* Patients with either unresectable Stage IIIc or IV BRAFV600 mutation-positive metastatic melanoma or other malignant BRAFV600 mutation-positive tumor type and who have no acceptable standard treatment options
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
* Full recovery from any major surgery or significant traumatic injury at least 14 days prior to the first dose of study treatment
* Adequate hematologic and end organ function
* Female patients of childbearing potential and male patients with female partners of childbearing potential must agree to use 2 effective methods of contraception as defined by protocol during the course of the study and for at least 6 months after completion of study treatment
Exclusion Criteria:
* Prior treatment with vemurafenib or other BRAF inhibitor within 42 days of Day 1
* Prior anti-cancer therapy within 28 days (6 weeks for nitrosureas or mitocyn C, or 14 days for hormonal therapy or kinase inhibitors) before the first dose of study treatment Day 1
* Palliative radiotherapy within 2 weeks prior to first dose of study treatment Day 1
* Experimental therapy within 4 weeks prior to first dose of study treatment Day 1
* History of clinically significant cardiac or pulmonary dysfunction, including current uncontrolled Grade \>/=2 hypertension or unstable angina
* Current Grade \>/=2 dyspnea or hypoxia or need for oxygen supplementation
* History of myocardial infarction within 6 months prior to first dose of study treatment
* Active central nervous system lesions (i.e. patients with radiographically unstable, symptomatic lesions)
* History of bleeding or coagulation disorders
* Allergy or hypersensitivity to vemurafenib or phenprocoumon formulations
* History of malabsorption or other condition that would interfere with the enteral absorption of study treatment
* History of clinically significant liver disease (including cirrhosis), current alcohol abuse, or active hepatitis B or hepatitis C virus infection
* Human immunodeficiency virus (HIV) infection requiring antiretroviral treatment, or AIDS-related illness
* Pregnant or lactating women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01849666
Study Brief:
Protocol Section:
NCT01849666