Safety of BKM120 Monotherapy in Advanced Solid Tumor Patients

Novartis

Status and phase

Completed

Phase 1

Conditions

Breast Cancer

Endometrium Cancer

Colon Cancer

Ovarian Cancer

Treatments

Drug: BKM120

Study type

Interventional

Funder types

Industry

Identifiers

NCT01068483

CBKM120X2101

2008-002652-17 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

107 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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