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

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
First received: January 11, 2008
Last updated: November 26, 2012
Last verified: November 2012

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.

Condition Intervention Phase
Solid Tumors
Breast Cancer
Cowden Syndrome
Drug: BGT226
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Novartis:

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) [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

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 [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: December 2007
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BGT226 Drug: BGT226


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00600275

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana Faber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Nevada
Nevada Cancer Center
Las Vegas, Nevada, United States, 89135
United States, Texas
Cancer Therapy and Research Center (CTRC)
San Antonio, Texas, United States, 78229
Princess Margaret Hospital
Toronto, Canada
Novartis Investigative Site
Barcelona, Spain
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00600275     History of Changes
Other Study ID Numbers: CBGT226A2101 
Study First Received: January 11, 2008
Last Updated: November 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
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)

Additional relevant MeSH terms:
Breast Neoplasms
Hamartoma Syndrome, Multiple
Breast Diseases
Genetic Diseases, Inborn
Neoplasms by Site
Neoplasms, Multiple Primary
Neoplastic Syndromes, Hereditary
Skin Diseases

ClinicalTrials.gov processed this record on May 26, 2016