Safety of BKM120 Monotherapy in Advanced Solid Tumor Patients

Phase 1

Completed

• Conditions: Ovarian Cancer; Endometrium Cancer; Breast Cancer; Colon Cancer
• Interventions: Drug: BKM120

• Registration Number: NCT01068483
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2010-02-11
• Study First Submitted QC: 2010-02-11
• Study First Posted: 2010-02-15
• Primary Completion: 2011-09
• Study Completion: 2012-08
• Status Verified: 2013-04
• Last Update Submitted: 2020-12-06
• Last Update Posted: 2020-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BKM120	BKM120	Dose escalation followed by dose expansion

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose (MTD) of BKM120	throughout the study

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of BKM120	throughout the study
Changes in tumor metabolic activity	throughout the study
Safety and tolerability of BKM120	throughout the study
Pharmacodynamics of BKM120	throughout the study
Clinical tumor response in patients with tumors that show PI3K pathway activation	throughout the study

Trial Locations

Locations (2)

Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(4); 🇺🇸 Nashville, Tennessee, United States

Novartis Investigative Site; 🇪🇸 Barcelona, Cataluna, Spain