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Safety of BKM120 Monotherapy in Advanced Solid Tumor Patients

Primary Purpose

Breast Cancer, Colon Cancer, Ovarian Cancer

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BKM120
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Advanced solid tumors, Breast Cancer, Colon Cancer, Ovarian Cancer, Endometrium cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(4)
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BKM120

Arm Description

Dose escalation followed by dose expansion

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose (MTD) of BKM120

Secondary Outcome Measures

Safety and tolerability of BKM120
Pharmacokinetics of BKM120
Changes in tumor metabolic activity
Pharmacodynamics of BKM120
Clinical tumor response in patients with tumors that show PI3K pathway activation

Full Information

First Posted
February 11, 2010
Last Updated
December 6, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01068483
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Colon Cancer, Ovarian Cancer, Endometrium Cancer
Keywords
Advanced solid tumors, Breast Cancer, Colon Cancer, Ovarian Cancer, Endometrium cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BKM120
Arm Type
Experimental
Arm Description
Dose escalation followed by dose expansion
Intervention Type
Drug
Intervention Name(s)
BKM120
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose (MTD) of BKM120
Time Frame
throughout the study
Secondary Outcome Measure Information:
Title
Safety and tolerability of BKM120
Time Frame
throughout the study
Title
Pharmacokinetics of BKM120
Time Frame
throughout the study
Title
Changes in tumor metabolic activity
Time Frame
throughout the study
Title
Pharmacodynamics of BKM120
Time Frame
throughout the study
Title
Clinical tumor response in patients with tumors that show PI3K pathway activation
Time Frame
throughout the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(4)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Novartis Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Novartis Investigative Site
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Rotterdam
ZIP/Postal Code
3075 EA
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Cataluna
ZIP/Postal Code
08035
Country
Spain

12. IPD Sharing Statement

Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=7084
Description
Results for CBKM120X2101 can be found on the Novartis Clinical Trial Results Website

Learn more about this trial

Safety of BKM120 Monotherapy in Advanced Solid Tumor Patients

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