BGT226

Novartis Pharmaceuticals

This study will confirm safety and tolerability and determine the MTD of BGT226 in Japanese patients with advanced solid tumor.

Phase I Study to Determine the Maximum Tolerate Dose (MTD) of BGT226 in Advanced Solid Tumors in Japan

A Phase I Study of BGT226, Administered Orally in Adult Patients With Advanced Solid Tumor in Japan

Safety measures by Common Terminology Criteria for Adverse Events (CTCAE)

Measured by Response Evaluation criteria in Solid Tumors (RECIST)

Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Syndrome

Breast Neoplasms

Hamartoma Syndrome, Multiple

Hamartoma

Breast Diseases

Skin Diseases

Neoplasms, Multiple Primary

Neoplastic Syndromes, Hereditary

Genetic Diseases, Inborn

Cowden Syndrome

Bannayan-Riley-Ruvalcaba Syndrome

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.

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

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 title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase I Study to Determine the Maximum Tolerate Dose (MTD) of BGT226 in Advanced Solid Tumors in Japan	NCT00742105	Cancer Solid Tumor Advanced Solid ...	BGT226	20 Years -	Novartis
Phase I Study to Determine the Maximum Tolerate Dose (MTD) of BGT226 in Advanced Solid Tumors in Japan	NCT00742105	Cancer Solid Tumor Advanced Solid ...	BGT226	20 Years -	Novartis
A Phase I/II Study of BGT226 in Adult Patients With Advanced Solid Malignancies Including Patients With Advanced Breast Cancer	NCT00600275	Solid Tumors Breast Cancer Cowden Syndrome	BGT226	18 Years -	Novartis

Spots Global Cancer Trial Database for bgt226

Every month we try and update this database with for bgt226 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for bgt226

Every month we try and update this database with for bgt226 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for bgt226 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.