Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Millennium Pharmaceuticals, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Each patient must meet all of the following criteria to be enrolled in the study:
Diagnosis of metastatic melanoma
Measurable disease
Female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse
Male patients who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse
Willing and able to give written informed consent
Suitable venous access for study-required blood sampling
Appropriate functional status, including the recovery from the effects of prior antineoplastic therapy, and acceptable organ function as described in the protocol
You may not be if
Major surgery or, serious infections, or infections that required systematic antibiotic therapy within 14 days before the first dose of study drug
Systemic antineoplastic or radiation therapy within 14 days or treatment with any investigational products within 21 days before the first dose of study treatment
CYP3A inducers within 14 days of study treatment. Moderate and strong CYP3A inhibitors and CYP3A inducers are not permitted during the study
No prior history of amiodarone in the 6 months before the first dose of MLN4924
Diarrhea that is greater than Grade 1 as outlined in the protocol
Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure, angina, or myocardial infarction within the past 6 months
Known human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection.
Serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol
Other clinical and laboratory assessments that do not meet the criteria specified in the protocol
Clareo Health | Dose Escalation Study of MLN4924 in Adults With Melanoma
