A Phase IA, Multicenter, Open-label Dose Escalation Study of BKM120, Administered Orally in Adult Patients With Advanced Solid Malignancies
Inclusion Criteria:
All patients:
- Histologically-confirmed advanced solid tumors
- Progressive, recurrent unresectable disease
- World Health Organization (WHO) Performance status ≤ 2
- No history of primary brain tumor or brain metastases
MTD Expansion part:
- Histologically-confirmed advanced solid tumors
- Progressive, recurrent unresectable disease
- World Health Organization (WHO) Performance status ≤ 2
- No history of primary brain tumor; no brain metastases unless asymptomatic and
clinically stable for ≥ 3 months
- Patients with genetic or molecular alteration of the PI3K pathway
Exclusion Criteria:
- Prior treatment with a PI3K inhibitor
- History of or active major depressive episode, bipolar disorder, schizophrenia, or
history of suicidal attempt or ideation
- No clinically manifest diabetes mellitus (treated and/or with clinical signs)
- No acute or chronic renal disease
- No acute or chronic liver disease
- No acute or chronic pancreatitis
- No unresolved diarrhea
- No impaired cardiac function or clinically significant cardiac diseases such as
ventricular arrhythmia, congestive heart failure, uncontrolled hypertension
- No acute myocardial infarction or unstable angina pectoris within the past 3 months
- Not pregnant or nursing and fertile patients must use barrier contraceptives
Other protocol-defined inclusion/exclusion criteria may apply