drugset / Trial / NCT00600275

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

NCT00600275 ↗

Phase 1/2 Completed 57 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2007-12
Primary completion
2010-03
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject BGT226 Small molecule — Oral