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A Phase I/II Study of BGT226 in Adult Patients With Advanced Solid Malignancies Including Patients With Advanced Breast Cancer

Primary Purpose

Solid Tumors, Breast Cancer, Cowden Syndrome

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BGT226
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Tumors focused on measuring BGT226, Solid tumors, Breast cancer, Cowden Syndrome, Phosphatidylinositol 3'-kinase (PI3K) inhibitor, Advanced solid tumors (including sporadic and Cowden Syndrome) (Phase I part), Advanced breast cancer (including sporadic and Cowden Syndrome) (Phase II part)

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

Phase II expansion part (advanced breast cancer)

  • Confirmed positive hormone receptor (estrogen receptor and/or progesterone receptor) or positive HER-2 expression status
  • Disease progression/recurrence following hormonal or anti-HER-2 treatment for advanced disease
  • At least one but not more than two prior chemotherapy regimens for the unresectable tumor
  • Measurable disease by MRI or CT scan

Cowden Syndrome patients with an advanced malignancy Genetic confirmation of Cowden Syndrome

  • Age ≥ 18
  • World Health Organization (WHO) Performance Status of ≤ 2

Exclusion criteria:

  • Hematopoietic:
  • No diabetes mellitus or history of gestational diabetes mellitus
  • No acute or chronic renal disease
  • No acute or chronic liver disease
  • No acute or chronic pancreatitis
  • 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

  • Massachusetts General Hospital
  • Dana Faber Cancer Institute
  • Nevada Cancer Center
  • Cancer Therapy and Research Center (CTRC)
  • Princess Margaret Hospital
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BGT226

Arm Description

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose (MTD) of BGT226 (Phase I dose escalation) Safety and tolerability of BGT226 (all patients) Clinical tumor response in patients with advanced breast cancer (Phase II)

Secondary Outcome Measures

Pharmacodynamics Changes in biological markers indicative of the inhibitory effect of BGT226. Changes in cellular physiology as assessed by Positron Emission Tomography (PET) imaging

Full Information

First Posted
January 11, 2008
Last Updated
December 11, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00600275
Brief Title
A Phase I/II Study of BGT226 in Adult Patients With Advanced Solid Malignancies Including Patients With Advanced Breast Cancer
Official Title
A Phase I/II, Multi-center, Open-label Study of BGT226, Administered Orally in Adult Patients With Advanced Solid Malignancies Including Patients With Advanced Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
This is a phase I/II clinical research study with BGT226, an inhibitor of phosphatidylinositol 3'-kinase (PI3K). The study consists of a Phase I dose escalation part followed by a safety expansion part and a Phase II expansion part. Once the MTD has been defined, the safety expansion and efficacy expansion parts of the trial will be opened for enrollment. Phase I safety expansion part will enroll advanced solid tumors. Phase II expansion part will enroll advanced breast cancer. An effort will be made to enrich the trial population with Cowden Syndrome patients with advanced solid malignancies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumors, Breast Cancer, Cowden Syndrome
Keywords
BGT226, Solid tumors, Breast cancer, Cowden Syndrome, Phosphatidylinositol 3'-kinase (PI3K) inhibitor, Advanced solid tumors (including sporadic and Cowden Syndrome) (Phase I part), Advanced breast cancer (including sporadic and Cowden Syndrome) (Phase II part)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BGT226
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BGT226
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose (MTD) of BGT226 (Phase I dose escalation) Safety and tolerability of BGT226 (all patients) Clinical tumor response in patients with advanced breast cancer (Phase II)
Time Frame
throughout the study
Secondary Outcome Measure Information:
Title
Pharmacodynamics Changes in biological markers indicative of the inhibitory effect of BGT226. Changes in cellular physiology as assessed by Positron Emission Tomography (PET) imaging
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 Phase II expansion part (advanced breast cancer) Confirmed positive hormone receptor (estrogen receptor and/or progesterone receptor) or positive HER-2 expression status Disease progression/recurrence following hormonal or anti-HER-2 treatment for advanced disease At least one but not more than two prior chemotherapy regimens for the unresectable tumor Measurable disease by MRI or CT scan Cowden Syndrome patients with an advanced malignancy Genetic confirmation of Cowden Syndrome Age ≥ 18 World Health Organization (WHO) Performance Status of ≤ 2 Exclusion criteria: Hematopoietic: No diabetes mellitus or history of gestational diabetes mellitus No acute or chronic renal disease No acute or chronic liver disease No acute or chronic pancreatitis 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
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana Faber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Nevada Cancer Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Facility Name
Cancer Therapy and Research Center (CTRC)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Princess Margaret Hospital
City
Toronto
Country
Canada
Facility Name
Novartis Investigative Site
City
Barcelona
Country
Spain

12. IPD Sharing Statement

Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=3640
Description
Results for CBGT226A2101 from the Novartis Clinical Trials website

Learn more about this trial

A Phase I/II Study of BGT226 in Adult Patients With Advanced Solid Malignancies Including Patients With Advanced Breast Cancer

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