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

Phase 1

Completed

• Conditions: Solid Tumors; Breast Cancer; Cowden Syndrome
• Interventions: Drug: BGT226

• 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

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-01-11
• Study First Submitted QC: 2008-01-23
• Study First Posted: 2008-01-24
• Primary Completion: 2010-03
• Disposition First Submitted: 2012-05-01
• Disposition First Submitted QC: 2012-05-01
• Disposition First Posted: 2012-05-03
• Status Verified: 2012-11
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

Not provided

Exclusion Criteria

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)

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