Safety of BKM120 Monotherapy in Advanced Solid Tumor Patients

December 6, 2020 updated by: Novartis Pharmaceuticals

A Phase IA, Multicenter, Open-label Dose Escalation Study of BKM120, Administered Orally in Adult Patients With Advanced Solid Malignancies

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Novartis Investigative Site
  • Netherlands
      • Rotterdam, Netherlands, 3075 EA
        • Novartis Investigative Site
      • Rotterdam, Netherlands, 3015 CE
        • Novartis Investigative Site
  • Spain
    • Cataluna
      • Barcelona, Cataluna, Spain, 08035
        • Novartis Investigative Site
  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(4)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BKM120
Dose escalation followed by dose expansion
Drug: BKM120

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum Tolerated Dose (MTD) of BKM120
Time Frame: throughout the study
throughout the study

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

February 11, 2010

First Submitted That Met QC Criteria

February 11, 2010

First Posted (Estimate)

February 15, 2010

Study Record Updates

Last Update Posted (Actual)

December 8, 2020

Last Update Submitted That Met QC Criteria

December 6, 2020

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBKM120X2101
  • 2008-002652-17 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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