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

Novartis

Status and phase

Completed

Phase 2

Phase 1

Conditions

Breast Cancer

Cowden Syndrome

Solid Tumors

Treatments

Drug: BGT226

Study type

Interventional

Funder types

Industry

Identifiers

NCT00600275

CBGT226A2101

Details and patient eligibility

About

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.

Enrollment

57 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.