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A Phase I, Open-Label, Dose Escalation Study of MLN4924, a Novel Inhibitor of Nedd8-Activating Enzyme, in Adult Patients With Melanoma

Phase 1
18 Years
Not Enrolling
Metastatic Melanoma

Thank you

Trial Information

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

- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD) and inform recommended phase 2 dose of MLN4924

Outcome Time Frame:

Up to 12 months of treatment

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

December 2009

Completion Date:

January 2013

Related Keywords:

  • Metastatic Melanoma
  • Melanoma
  • Melanoma



The Angeles Clinic and Research InstituteLos Angeles, California  90025