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
18 years or older
Patients must have a diagnosis of an advanced malignant solid tumor or hematologic malignancy for which standard, curative, or life-prolonging treatment does not exist or is no longer effective
Total bilirubin and aspartate aminotransferase (AST) levels consistent with normal hepatic function (total bilirubin and AST ≤ the upper limit of normal), moderate hepatic impairment (total bilirubin \> 1.5 to 3x the upper limit of normal with any AST level) or severe hepatic impairment (total bilirubin \> 3x the upper limit of normal with any AST level)
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
Female patients who are postmenopausal for at least 1 year OR are surgically sterile OR if of childbearing potential, agree to practice 2 effective methods of contraception at the same time during the entire study through 90 days after the last dose of study drug OR agree to practice true abstinence
Male patients who agree to practice effective barrier contraception during the entire study and through 90 days after the last dose of study drug OR agree to practice true abstinence
Voluntary written consent
Suitable venous access for the conduct of blood sampling
Appropriate clinical laboratory values as specified in the protocol
You may not be if
Systemic treatment with strong and moderate inhibitors of CYP1A2, strong and moderate inhibitors of CYP3A, or clinically significant CYP3A inducers or use of Ginkgo biloba or St. John's wort within 14 days before the first dose of study drug
Use of any nicotine-containing products within 14 days before the first dose of study drug
Central Nervous System Involvement or Symptomatic brain metastasis. Patients with brain metastases: must have stable neurologic status following local therapy (surgery or radiation) for at least 2 weeks after completion of the definitive therapy; and must be without neurologic dysfunction that would confound the evaluation of neurologic and other AEs
Female patients who are lactating or breastfeeding or have a positive serum pregnancy test
Serious medical or psychiatric illness that could interfere with participation in the study
Treatment with any investigational products or radiotherapy within 21 days before the first dose of study drug
Systemic anticancer therapy within 14 days before the first dose of study drug
Exposure to nitrosoureas or mitomycin C within 6 weeks before the first dose of study drug
Treatment with therapeutic monoclonal antibodies or antibody-drug conjugates within 60 days before the first dose of study drug
Radiotherapy or major surgery within the 14 days preceding the first dose of study drug
Infection requiring systemic intravenous antibiotic therapy or other serious infection within 14 days before the first dose of study drug
Life-threatening illness unrelated to cancer
Severe CNS, pulmonary, or renal disease not related to the patient's cancer
Known human immunodeficiency virus (HIV) positive
Evidence of uncontrolled cardiovascular conditions
QTc \> 500 milliseconds (msec) on a 12-lead ECG obtained during the Screening period
Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of IXAZOMIB
Known allergy to the study medication, its analogues, or excipients in the formulation
Clareo Health | Pharmacokinetic Study of Oral IXAZOMIB in Cancer Patients With Liver Dysfunction
