A Phase I/II Study of BGT226 in Adult Patients With Advanced Solid Malignancies Including Patients With Advanced Breast Cancer
- Registration Number
- NCT00600275
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BGT226 BGT226 -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (6)
Nevada Cancer Center
🇺🇸Las Vegas, Nevada, United States
Princess Margaret Hospital
🇨🇦Toronto, Canada
Novartis Investigative Site
🇪🇸Barcelona, Spain
Dana Faber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Cancer Therapy and Research Center (CTRC)
🇺🇸San Antonio, Texas, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States