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: July 15, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Metastatic Melanoma
Drug: MLN4924
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label, Dose Escalation Study of MLN4924, a Novel Inhibitor of Nedd8-Activating Enzyme, in Adult Patients With Melanoma

Resource links provided by NLM:


Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 37
Study Start Date: December 2009
Study Completion Date: January 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MLN4924
MLN4924 via IV infusion
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01011530

Locations
United States, California
The Angeles Clinic and Research Institute
Santa Monica, California, United States, 90404
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01011530     History of Changes
Other Study ID Numbers: C15005
Study First Received: November 9, 2009
Last Updated: July 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Millennium Pharmaceuticals, Inc.:
Melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on April 16, 2014