A Safety and Pharmacokinetic Study of TAK-228 in Combination With TAK-117 in Adult Participants With Advanced Nonhematologic Malignancies

Exclusion Criteria

• •Female participants who are lactating and breastfeeding or have a positive serum pregnancy test during the Screening period or a positive urine pregnancy test on Day 1 before first dose of study drug
• •Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment
• •Treatment with any investigational products within 30 days before the first dose of study drug
• •Previous treatment with TAK-117 and/or TAK-228; previous treatment with dual mTORC1/2 or dual PI3K-mTOR inhibitors
• •Failed to have recovered from the reversible effects of previous anticancer therapies
• •Have received systemic corticosteroid (inhalers are allowed) within 7 days before the first administration of study drug
• •Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of study drug
• •Diagnosis of diabetes mellitus
• •Other clinically significant co-morbidities, such as uncontrolled pulmonary disease, active CNS disease, active infection
• •Known human immunodeficiency virus (HIV) infection
• •Cardiovascular conditions as defined in the protocol
• •A requirement for positive inotropic support (excluding digoxin) or serious uncontrolled cardiac arrhythmia (including atrial flutter/fibrillation) within 1 year before screening
• •Participants who are taking proton pump inhibitors within 7 days of the first dose or who require treatment with proton pump inhibitors during the trial or those who are taking histamine-2 (H2) receptor antagonists within 24 hours of the first dose
• •Diagnosis of primary brain tumor or symptomatic brain metastasis. Participants with brain metastases must be without neurologic dysfunction that would confound the evaluation of neurologic and other adverse events (AEs)