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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01011530

Enrollment

Registered

2009-11-11

Start date

2009-12-31

Completion date

2013-01-31

Last updated

2013-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Melanoma

Keywords

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.

Interventions

DRUGMLN4924

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 design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026