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

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.

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Key information

Conditions

Solid Tumors Breast Cancer Breast Diseases Breast Neoplasms Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cowden Syndrome Genetic Diseases, Inborn Hamartoma Hamartoma Syndrome, Multiple Hereditary Sensory and Autonomic Neuropathies Heredodegenerative Disorders, Nervous System Neoplasms Neoplasms by Site Neoplasms, Multiple Primary Neoplastic Syndromes, Hereditary Nervous System Diseases Nervous System Malformations Neurodegenerative Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Polyneuropathies Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Princess Margaret Hospital, Toronto, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BGT226

Drug

Primary outcomes

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 outcomes

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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start: 2007
Primary completion: 2010
First posted: Jan 24, 2008
Registry last updated: Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed