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
Subjects have had their PIK3CA gene mutation status assessed prior to enrolling into the study
Subjects must have documented disease progression prior to enrolling into the study
You may not be if
Age greater than or equal to (\>=) 18 years, including males and females;
Eastern cooperative oncology group (ECOG) performance status (PS) 0-1;
Adequate organ function;
Male subjects must be surgically sterile or must agree to use physician-approved contraception during the study and for 30 days following the last study drug administration;
Ability to swallow oral medications;
Ability to understand and willingness to sign informed consent prior to initiation of any study procedures;
For women of child-bearing potential, negative serum pregnancy test within 14 days prior to the first study drug administration and use of physician-approved method of birth control from 30 days prior to the first study drug administration to 30 days following the last study drug administration
Diagnosis of primary brain tumor; untreated brain metastasis or history of leptomeningeal disease or spinal cord compression;
Received prior cancer or other investigational therapy within 2 weeks prior to the first administration of study drug;
Have received a systemic corticosteroid within one week prior to the first administration of study drug;
Clinically significant cardiac disease;
Myocardial infarction or unstable angina within 6 months prior to the first administration of study drug;
Malabsorption ;
Poorly controlled diabetes mellitus;
Pregnancy (positive serum or urine pregnancy test) or breast feeding;
Untreated brain metastasis or history of leptomeningeal disease or spinal cord compression;
Failed to recover from the reversible effects of prior anticancer therapies;
Have received a selective phosphoinositide-3-kinase alpha isoform (PI3K-alpha) inhibitor
Other clinically significant co-morbidities, such as uncontrolled pulmonary disease, active central nervous system (CNS) disease, active infection, or any other condition that could compromise the subject's participation in the study
Known human immunodeficiency virus (HIV) infection
Have a secondary malignancy within the last 3 years prior to first dose of study drug, excluding treated non-melanoma skin cancer, carcinoma in situ, or locally-treated prostate cancer
