Breast Cancer, Colon Cancer, Endometrium Cancer, Ovarian Cancer
Conditions
Keywords
Advanced solid tumors, Breast Cancer, Colon Cancer, Ovarian Cancer, Endometrium cancer
Brief 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.
Interventions
DRUGBKM120
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Tolerated Dose (MTD) of BKM120 | throughout the study |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability of BKM120 | throughout the study |
| Pharmacokinetics of BKM120 | throughout the study |
| Changes in tumor metabolic activity | throughout the study |
| Pharmacodynamics of BKM120 | throughout the study |
| Clinical tumor response in patients with tumors that show PI3K pathway activation | throughout the study |
Countries
Canada, Netherlands, Spain, United States
Outcome results
None listed