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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01068483
Other study ID # CBKM120X2101
Secondary ID 2008-002652-17
Status Completed
Phase Phase 1
First received
Last updated
Start date November 2008
Est. completion date August 2012

Study information

Verified date April 2013
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
BKM120


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  Netherlands,  Spain, 

Outcome

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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