Breast Cancer Clinical Trial
Official title:
A Phase IA, Multicenter, Open-label Dose Escalation Study of BKM120, Administered Orally in Adult Patients With Advanced Solid Malignancies
Verified date | April 2013 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 107 |
Est. completion date | August 2012 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Novartis Investigative Site | Toronto | Ontario |
Netherlands | Novartis Investigative Site | Rotterdam | |
Netherlands | Novartis Investigative Site | Rotterdam | |
Spain | Novartis Investigative Site | Barcelona | Cataluna |
United States | Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(4) | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States, Canada, Netherlands, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum Tolerated Dose (MTD) of BKM120 | throughout the study | ||
Secondary | Safety and tolerability of BKM120 | throughout the study | ||
Secondary | Pharmacokinetics of BKM120 | throughout the study | ||
Secondary | Changes in tumor metabolic activity | throughout the study | ||
Secondary | Pharmacodynamics of BKM120 | throughout the study | ||
Secondary | Clinical tumor response in patients with tumors that show PI3K pathway activation | throughout the study |
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