Brief Title
Safety of BKM120 Monotherapy in Advanced Solid Tumor Patients
Official Title
A Phase IA, Multicenter, Open-label Dose Escalation Study of BKM120, Administered Orally in Adult Patients With Advanced Solid Malignancies
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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Maximum Tolerated Dose (MTD) of BKM120
Secondary Outcome
Safety and tolerability of BKM120
Condition
Breast Cancer
Intervention
BKM120
Study Arms / Comparison Groups
BKM120
Description: Dose escalation followed by dose expansion
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
107
Start Date
November 2008
Completion Date
August 2012
Primary Completion Date
September 2011
Eligibility 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Novartis Pharmaceuticals, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT01068483
Organization ID
CBKM120X2101
Secondary IDs
2008-002652-17
Responsible Party
Sponsor
Study Sponsor
Novartis Pharmaceuticals
Study Sponsor
Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals
Verification Date
April 2013