Dose Escalation Study of MLN4924 in Adults With Melanoma

Phase 1

Completed

• Conditions: Metastatic Melanoma
• Interventions: Drug: MLN4924

• Registration Number: NCT01011530
• Lead Sponsor: Millennium Pharmaceuticals, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-11-09
• Study First Submitted QC: 2009-11-10
• Study First Posted: 2009-11-11
• Study Start: 2009-12
• Primary Completion: 2012-05
• Study Completion: 2013-01
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-15
• Last Update Posted: 2013-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MLN4924	MLN4924	MLN4924 via IV infusion

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose (MTD) and inform recommended phase 2 dose of MLN4924	Up to 12 months of treatment

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamic effects of MLN4924 on blood and tumor cells	Primarily assessed during the first cycle of therapy
Anti-tumor activities of MLN4924	Up to 12 months of treatment

Trial Locations

Locations (1)

The Angeles Clinic and Research Institute; 🇺🇸 Santa Monica, California, United States