A Phase I, Open-Label, Dose Escalation Study of MLN4924, a Novel Inhibitor of Nedd8-Activating Enzyme, in Adult Patients With Melanoma
Inclusion Criteria:
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
Exclusion Criteria:
Patients meeting any of the following exclusion criteria are not to be enrolled in the
study:
- 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