Study of MLN4924 in Adult Patients With Nonhematologic Malignancies
- Registration Number
- NCT00677170
- Lead Sponsor
- Millennium Pharmaceuticals, Inc.
- 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
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 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 MLN4924 MLN4924
- Primary Outcome Measures
Name Time Method Determine the safety profile, MTD and PK/pharmacodynamics of MLN4924 Maximum duration of therapy for 12 months
- Secondary Outcome Measures
Name Time Method Disease response Day 21, every other cycle and end of study
Trial Locations
- Locations (3)
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Institute for Drug Development
🇺🇸San Antonio, Texas, United States
Cancer Therapy & Research Center at the UT Health Science Center
🇺🇸San Antonio, Texas, United States