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Brief Title: A Phase I/II Study of BGT226 in Adult Patients With Advanced Solid Malignancies Including Patients With Advanced Breast Cancer
Official 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
Study ID: NCT00600275
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:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana Faber Cancer Institute, Boston, Massachusetts, United States
Nevada Cancer Center, Las Vegas, Nevada, United States
Cancer Therapy and Research Center (CTRC), San Antonio, Texas, United States
Princess Margaret Hospital, Toronto, , Canada
Novartis Investigative Site, Barcelona, , Spain
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR