A Phase I/II Study of BGT226 in Adult Patients With Advanced Solid Malignancies Including Patient… (NCT00600275) | Clinical Trial Compass
CompletedPhase 1/2
A Phase I/II Study of BGT226 in Adult Patients With Advanced Solid Malignancies Including Patients With Advanced Breast Cancer
United States, Canada, Spain57 participantsStarted 2007-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)