Dose Escalation Study of MLN4924 in Adults With Melanoma

Millennium Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Metastatic Melanoma

Treatments

Drug: MLN4924

Study type

Interventional

Funder types

Industry

Identifiers

NCT01011530

C15005

Details and patient eligibility

About

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.

Enrollment

37 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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