Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Millennium Pharmaceuticals, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
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
