A Study of BYL719 in Adult Patients With Advanced Solid Malignancies, Whose Tumors Have an Alteration of the PIK3CA Gene

Exclusion Criteria

• •Brain metastasis unless treated and free of signs/symptoms attributable to brain metastasis in the absence of corticosteroid therapy (anti-epileptic therapy is allowed).
• •Prior treatment with PI3K, AKT or mTOR inhibitor and failure to benefit
• •Patient with peripheral neuropathy NCI-CTC Grade ≥ 3
• •Patient with diarrhea NCI-CTC Grade ≥ 2
• •Patient with acute or chronic pancreatitis
• •Impaired cardiac function or clinically significant cardiac disease incl. unstable angina pectoris ≤ 3 months prior to starting study drug and Acute Myocardial Infarction (AMI) ≤ 3 months prior to starting study drug.
• •Patients with clinically manifest diabetes mellitus, history of gestational diabetes mellitus or documented steroid-induced diabetes mellitus
• •Women who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control