Safety of BKM120 Monotherapy in Advanced Solid Tumor Patients

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a first-in-man, phase I clinical research study with BKM120, a potent and highly specific oral pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor. The study consists of a dose escalation part followed by a MTD expansion part.

Once the MTD has been defined, the MTD expansion part will be opened for enrollment.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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