Status:
COMPLETED
Study of MLN4924 in Adult Patients With Nonhematologic Malignancies
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Advanced Nonhematologic Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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. Th...
Eligibility Criteria
Inclusion
- 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
- 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 radiation therapy involving ≥25% of the hematopoietically active bone marrow
- CYP3A inducers within 14 days before the first dose of MLN4924. Moderate and strong CYP3A inhibitors and CYP3A inducers are not permitted during the study.
- Clinically significant central nervous system metastases
- Absolute neutrophil count \<1,500/mm3; platelet count \<100,000/mm3
- Patients with a prothrombin time or aPTT \> 1.5 x 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00677170
Start Date
April 1 2008
End Date
December 1 2012
Last Update
July 16 2013
Active Locations (3)
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1
Emory University Hospital
Atlanta, Georgia, United States, 30322
2
Cancer Therapy & Research Center at the UT Health Science Center
San Antonio, Texas, United States, 78229
3
Institute for Drug Development
San Antonio, Texas, United States, 78229