Study of MLN4924 in Adult Patients With Nonhematologic Malignancies - Full Text View

Sponsored by:	Millennium Pharmaceuticals, Inc.
Information provided by:	Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00677170

Purpose

This study is an open-label, multicenter, Phase 1, dose escalation study of MLN4924 in adult patients with nonhematologic malignancies. This study will be the first to administer MLN4924 in humans. The patient population will consist of adults with any form of nonhematologic malignancy for which standard, curative, life prolonging, or palliative treatment does not exist or is no longer effective.

Condition	Intervention	Phase
Advanced Nonhematologic Malignancies	Drug: MLN4924	Phase I

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment
Official Title:	An Open-Label, Dose Escalation, Phase I Study of MLN4924, a Novel Inhibitor of Nedd8-Activating Enzyme, in Adult Patients With Nonhematologic Malignancies

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

Primary Outcome Measures:

Determine the safety profile, MTD and PK/pharmacodynamics of MLN4924 [ Time Frame: Maximum duration of therapy for 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Disease response [ Time Frame: Day 21, every other cycle and end of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	25
Study Start Date:	April 2008
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental MLN4924	Drug: MLN4924 IV dose escalation for 5 consecutive days followed by a rest period of 16 days for a 21 day cycle. Treated may continue until disease progression or unacceptable toxicity develops.

Eligibility

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

Criteria

Inclusion Criteria:

Male or female patients 18 years or older
Eastern Cooperative Oncology Group performance status 0-2
Patients must have a diagnosis of a nonhematologic malignancy for which standard curative, life-prolonging, or palliative treatment does not exist or is no longer effective.
Expected survival longer than 6 weeks from enrollment in the study
Radiographically or clinically evaluable tumor
Suitable venous access for the conduct of blood sampling for MLN4924
Tumor tissue that, in the opinion of the investigator, can be safely biopsied using a core needle
Male patients must use an appropriate method of barrier contraception
Female patients must be postmenopausal, surgically sterilized, or willing to use reliable methods of birth control
Voluntary written consent

Exclusion Criteria:

Pregnant or lactating
Major surgery within 14 days prior to the first dose of study treatment
Serious infection within 14 days prior to the first dose of study treatment
Receiving antibiotic therapy within 14 days prior to the first dose of study treatment
Life-threatening illness unrelated to cancer
Diarrhea that is greater than Grade 1 in severity
Systemic antineoplastic therapy within 21 days preceding first dose of study treatment
Radiotherapy within 21 days preceding first dose of study treatment
Prior treatment with radiationtherapy involving ≥25% of the hematopoietically active bone marrow
Use of moderate and strong CYP3A inhibitors and CYP3A inducers
Clinically significant central nervous system metastases
Absolute neutrophil count <1,500/mm3; platelet count <100,000/mm3
Patients with a prothrombin time or aPTT above the upper limit of the normal range, or with a history of a coagulopathy or bleeding disorder
Ongoing anti-coagulant therapy that can not be held to permit tumor biopsy
Calculated creatinine clearance <50 mL/minute
Bilirubin >1.5 times the upper limit of normal; aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase >2.5 times the upper limit of normal.
Uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure, angina, or myocardial infarction within the past 6 months
Abnormalities on 12-lead electrocardiogram including, but not limited to, changes in rhythm and intervals that in the opinion of the investigator are considered to be clinically significant
Known human immunodeficiency virus positive or hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection
Treatment with any investigational products within 28 days preceding the first dose of study treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00677170

Contacts

Contact: Christine Colby, PharmD

1-866-835-2233

medical@mlnm.com

Locations

United States, Georgia
Emory University Hospital	Recruiting
Atlanta, Georgia, United States, 30322
Contact: John Kauh, M.D.

Sponsors and Collaborators

Millennium Pharmaceuticals, Inc.

More Information

Responsible Party:	Millennium Pharmaceuticals, Inc. ( Clinical Study Medical Monitor )
Study ID Numbers:	C15001
Study First Received:	May 9, 2008
Last Updated:	May 13, 2008
ClinicalTrials.gov Identifier:	NCT00677170
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on January 14, 2009