Dose Escalation Study of MLN4924 in Adults With Melanoma

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Millennium Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT01011530

First received: November 9, 2009

Last updated: February 27, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

November 9, 2009

Last Updated Date

February 27, 2013

Start Date ^ICMJE

December 2009

Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Maximum Tolerated Dose (MTD) and inform recommended phase 2 dose of MLN4924 [ Time Frame: Up to 12 months of treatment ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01011530 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Anti-tumor activities of MLN4924 [ Time Frame: Up to 12 months of treatment ] [ Designated as safety issue: No ]
Pharmacodynamic effects of MLN4924 on blood and tumor cells [ Time Frame: Primarily assessed during the first cycle of therapy ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Dose Escalation Study of MLN4924 in Adults With Melanoma

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Metastatic Melanoma

Intervention ^ICMJE

Drug: MLN4924

Patients will be administered MLN4924 via an IV infusion. Each 21-day treatment cycle is composed of 2 weeks intermittent dosing of MLN4924 on Days 1, 4, 8 and 11, followed by a rest period of 10 days. A cohort of patients will receive a reduced first dose on Day 1, approximately half the strength of the dose received on Days 4, 8, 11 and dose will not be administered on Day 4 if the Day 1 dose is not tolerated.(Schedule A ramp-up), or continuous weekly dosing (Days 1, 8, and 15) of MLN4924 (Schedule B)

Study Arm (s)

Experimental: MLN4924

MLN4924 via IV infusion

Intervention: Drug: MLN4924

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2013

Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01011530

Other Study ID Numbers ^ICMJE

C15005

Has Data Monitoring Committee

Responsible Party

Millennium Pharmaceuticals, Inc.

Study Sponsor ^ICMJE

Millennium Pharmaceuticals, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Millennium Pharmaceuticals, Inc.

Information Provided By

Millennium Pharmaceuticals, Inc.

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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