BKM120 in Cancers With PIK3CA Activating Mutations

Breast Cancer Clinical Trial

Official title: An Open Label, Phase II Trial of BKM120 in Cancers With PIK3CA Activating Mutations

Status Withdrawn

Clinical Trial Summary

In people whos cancers have a PIK3CA mutation, this trial will be evaluating the drug BKM120 as a possible treatment. BKM120 works by blocking the phosphatidylinositol-3-kinase (PI3K)pathway, thereby inhibiting tumor growth and survival.

The purpose of this study is to learn if the study drug BKM120 can shrink or slow the growth of your tumor. The safety of BKM120 will also be studied. Your physical state, symptoms, change in the size of your tumor, and laboratory findings obtained while you are on study will help the research team decide if BKM120 is safe and effective in patients with advanced cancers.

Clinical Trial Description

Subjects enrolled in this study will receive BKM120 once daily, orally, in cycles of 28 days.

During Cycles 1 and 2, the following tests and procedures will be done on days 1 and 15:

• physical exam

• performance status

• blood tests

• pregnancy test (if applicable)

• neuropsychiatric assessments

Starting at Cycle 2 and then every other cycle thereafter (approximately every 8 weeks) tumor assessment will be performed by CT/MRI or PET scan. A chest x-ray will also be performed every 8 weeks.

Beginning with Cycle 3, the following tests/procedures will be performed on Day 1 of each cycle:

• physical exam

• performance status

• blood tests

• neuropsychiatric assessments ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Cholangiocarcinoma
• Colorectal Cancer
• Lung Cancer
• Solid Tumors

• NCT number: NCT01501604
• Study type: Interventional
• Source: Massachusetts General Hospital
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 2012
• Completion date: August 2013