BKM120 in Cancers With PIK3CA Activating Mutations

Inclusion Criteria:

* At least 1 site of measurable disease
* Life expectancy \>/= 12 weeks
* Adequate marrow and organ function
* Diagnosis of lung cancer, breast cancer, colorectal cancer, cholangiocarcinoma, gastric cancer, pancreatic cancer, prostate cancer, uterine cancer, ovarian cancer, esophageal cancer, or head and neck cancer
* Pathologically documented, definitively diagnosed, advanced solid tuor that is refractory to standard treatment, for which no standard therapy is available, or the subject refuses standard therapy
* Cancer must have at least one of the following PIK3CA mutations: E542K, E545K, H1047R, H1047L. The PIK3CA mutation must be documented in a CLIA approved laboratory

Exclusion Criteria:

* Prior treatment with a P13K inhibitor
* Known hypersensitivity to BKM120 or its excipients
* Untreated brain metastases
* Acute or chronic liver, renal disease or pancreatitis
* Currently treated with drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A
* Diarrhea \>/= CTCAE grade 2
* Any concurrent severe and/or uncontrolled medical condition
* Active cardiac disease
* History of cardiac dysfunction
* Poorly controlled diabetes mellitus or steroid-induced diabetes mellitus
* Significant symptomatic deterioration of lung function
* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BKDM120 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
* Currently taking therapeutic doses of warfarin sodium or any other coumadin-derivative anticoagulant
* Pregnant or breast-feeding
* Known diagnosis of HIV infection
* History of another malignancy within 3 years, except cured basal cell carcinoma of the skin or excised carcinoma in situ of the cervix
* Unable to swallow the medication in its prescribed form