This study will assess the safety of combining two agents (everolimus and BKM120) for the treatment of advanced cancer arising from solid organ in patients who are no longer benefiting from or unable to withstand standard treatment of these conditions.
Description: i. Grade 4 hematologic toxicity (excluding anemia) lasting more than 7 days ii. Grade 3 anemia lasting more than 7 days or requiring blood transfusion iii. Grade 4 anemia iv. Grade ≥ 3 febrile neutropenia of any duration v. Grade ≥ 3 nausea and or vomiting lasting more than 72 hours in spite of standard supportive therapy vi. Grade ≥ 3 non-hematologic toxicity (excluding alopecia)Measure: Dose limiting toxicity Time: During the first cycle of treatment; approximately 4 weeks
Description: Sum of complete response, partial response and stable diseaseMeasure: Clinical benefit rate Time: During the entire duration of therapy estimated to be an average of 6 months for each patient
Single Group Assignment
There is one SNP
Ability and willingness to undergo repeat tumor biopsies (the biopsy is optional and only applicable to subjects considered for the expansion cohort stage of the study) Exclusion Criteria: 1. Patients who have received prior treatment with a phosphatidylinositol 3-kinase (P13K) inhibitor or RAD001 (if discontinued for toxicity) 2. Patients with a known hypersensitivity to BKM120, RAD001 (including other rapalogs) or their excipients 3. Patients with untreated symptomatic brain metastases are excluded. --- P13K ---