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Dose Escalation Study of MLN4924 in Adults With Melanoma | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Dose Escalation Study of MLN4924 in Adults With Melanoma

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

NCT01011530•Millennium Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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

•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

Locations (1)

The Angeles Clinic and Research Institute

Santa Monica, California, United States

Key Dates

Start Date

December 1, 2009

Primary Completion Date

May 1, 2012

Completion Date

January 1, 2013

Last Updated

July 16, 2013

Enrollment

ACTUAL participants

Conditions

Metastatic Melanoma

Interventions

MLN4924

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 16, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Dose Escalation Study of MLN4924 in Adults With Melanoma

Inclusion Criteria

Exclusion Criteria

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