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.
Name: BKM120
Description: BKM120 (20mg to 100mg) will be self-administered (by the patients themselves). The investigator will instruct the patient to take the study drug exactly as specified in the protocol. BKM120 will be administered on a continuous once daily dosing schedule. Patients should be instructed to take the dose of BKM120 daily in the morning, one hour after a light breakfast (morning meal) at approximately the same time each day. BKM120 should be taken with a glass of water and consumed over as short a time as possible. Patients should swallow the capsules as a whole and not chew them. Patients should continue to fast for 2 hours after the administration of each BKM120 dose.Type: DrugCombination of BKM120 and everolimus
Name: Everolimus
Description: RAD001 will be self-administered (by the patients themselves). The investigator will instruct the patient to take the study drug exactly as specified in the protocol. RAD001 will be administered orally as once daily dose of 5mg or 10 mg (based on the dose cohort) continuously from study day 1 until progression of disease or unacceptable toxicity. Patients will be instructed to take RAD001 in the morning, at the same time each day.Type: DrugCombination of BKM120 and everolimus
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 weeksDescription: Sum of complete response, partial response and stable disease
Measure: Clinical benefit rate Time: During the entire duration of therapy estimated to be an average of 6 months for each patientSingle 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 ---