Breast Cancer, Cowden Syndrome, Solid Tumors
Conditions
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)
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.
Interventions
DRUGBGT226
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | throughout the study |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamics Changes in biological markers indicative of the inhibitory effect of BGT226. Changes in cellular physiology as assessed by Positron Emission Tomography (PET) imaging | throughout the study |
Countries
Canada, Spain, United States
Outcome results
None listed