Safety of BKM120 Monotherapy in Advanced Solid Tumor Patients

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

Clinical Trial Details — Status: Completed

Administrative data

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

Study information

• Verified date: April 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• 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

Related Conditions & MeSH terms

• Breast Cancer
• Colon Cancer
• Colonic Neoplasms
• Endometrial Neoplasms
• Endometrium Cancer
• Ovarian Cancer
• Ovarian Neoplasms

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

External Links

•   Results for CBKM120X2101 can be found on the Novartis Clinical Trial Results Website