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:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 12:59 AM
NCT ID:
NCT01942993
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed stage IV or unresectable stage III melanoma with documented BRAF V600 mutation
* Age \> 18 years
* ECOG Performance Status 0,1, or 2
* Measurable disease by RECIST v1.1
* Adequate organ function: Hemoglobin \> 9 g/dl, ANC\> 1.5 x 109/L, platelets \> 100 x 109/L, AST and ALT \< 2.5 x upper limit of normal, bilirubin \< 1.5 x upper limit normal, Cr \< 1.5 x upper limit normal
* Adequate recovery from prior systemic or local melanoma therapy. No systemic anticancer therapy in the 4 weeks and no ipilimumab in the 6 weeks from planned vemurafenib administration. No radiation therapy in 2 weeks prior to date plan to initiate vemurafenib treatment and no surgery in 3 weeks prior to date of planned vemurafenib administration.
* Agreement for females of childbearing potential use 2 acceptable methods contraception. Men with female partners of childbearing potential must agree to use of latex condom and advise female partner to use additional method contraception during the study and 6 months after discontinuation of vemurafenib
* Negative serum or urine pregnancy test within 7 days prior to and including the morning of day -7 (first potential day of research blood draw and tumor biopsy)
* Agreement not to donate blood or blood products or to donate sperm during the study and for at least 6 months after discontinuation of vemurafenib.
Exclusion Criteria:
* Prior vemurafenib treatment
* Use of oral or intravenous corticosteroids or other immunosuppressive medications such as cyclosporine or azathioprine. Subjects must not have received any systemic immunosuppressive drug such as corticosteroids for at least 2 weeks prior to study entry. Maintenance inhaled corticosteroids for controlled asthma or COPD or maintenance systemic steroids to correct autoimmune endocrinopathy due to prior ipilimumab treatment is allowed as is the use of topical steroids and anti-inflammatory eye drops.
* Symptomatic CNS metastases requiring steroid use.
* No active second malignancy
* Pregnant or breast feeding
* Mean QTc interval \> 450 (triplicate ECGs) or history congenital prolonged QT interval
* Any of the following within 3 months prior to study drug administration: myocardial infarction, unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism
* Inability to swallow pills
* Ongoing cardiac dysrhythmia \>2 (per NCI CTCAE, v4.0)
* Unwillingness to practice birth control
* Inability to comply with requirements of the protocol
* Uncontrolled medical illness such as infection requiring intravenous antibiotics.
* Known allergy to treatment medication (vemurafenib)
* Known active or chronic infection with HIV.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01942993
Study Brief:
Protocol Section:
NCT01942993