|Closed||Metastatic Melanoma||Phase I||NCT01011530|
This is an open-label, multicenter, phase 1, dose escalation study that will evaluate the safety profile, establish Maximum Tolerated Dose (MTD), and inform the recommended phase 2 dose of MLN4924 as well as evaluate antitumor activity in patients with metastatic melanoma.
|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
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.
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.
- Use of moderate and strong CYP3A inhibitors and CYP3A inducers within 14 days of study treatment.
- 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.
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
- Talk to your health care providers first before making decisions about your health care.
- Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.