Study design and patients
Tumors, diabetes symptoms, primary malignant tumors, diabetes
BRAIN METASTASES, DISEASES, SPINAL CORD COMPRESSION, TUMORS, CHRONIC PANCREATITIS, METASTASES, DIABETES
This was an open‐label, phase 1 dose‐escalation trial registered at Key inclusion criteria were as follows: (1) 18–75 years of age; (2) at least one measurable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1Key exclusion criteria were as follows: (1) previous treatment with PI3K, AKT, or mTOR inhibitors before enrollment; (2) previous treatment with potent CYP3A4 and/or CYP2C8 inhibitors or inducers within 7 days before enrollment; (3) unstable, untreated or newly onset brain metastases, spinal cord compression, or meningeal/brain stem metastases; (4) history of other primary malignant tumors; (5) diabetes symptoms or a history of diabetes; (6) acute or chronic pancreatitis; or (7) other severe diseases that might affect the safety and efficacy of patients.