Clinical Trial: A Phase I/II Study of BGT226 in Adult Patients With Advanced Solid Malignancies Including Patients With Advanced Breast Cancer
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
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 Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome: 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 ]
Original Primary Outcome: 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)
Current Secondary Outcome: 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 ]
Original Secondary Outcome: Pharmacokinetics Changes in biological markers indicative of the inhibitory effect of BGT226. Changes in cellular physiology as assessed by Positron Emission Tomography (PET) imaging
Information By: Novartis
Dates:
Date Received: January 11, 2008
Date Started: December 2007
Date Completion:
Last Updated: November 26, 2012
Last Verified: November 2012
