BKM120 in Advanced, Metastatic, or Recurrent Endometrial Cancers — BKM120  

Endometrial Cancer Clinical Trial

Official title: A Study of BKM120 as a Single Agent in First Line Therapy in Advanced, Metastatic, or Recurrent Endometrial Cancers

Status Withdrawn

Clinical Trial Summary

This is a phase II open label fixed dose study in subjects with advanced, metastatic, or refractory endometrial or ovarian, fallopian tube, or primary peritoneal cancer with PI3 kinase pathway activation as demonstrated by PIK3CA gene mutation, PTEN gene mutation, or PTEN null/low protein expression.

Clinical Trial Description

Given the mechanisms of action and the safety profiles and tolerability of BKM120 (NVP-BKM120), the use of this agent may provide benefit to patients with endometrial and ovarian cancer. Endometrial and ovarian cancer are leading causes of cancer death in women and there are limited treatment options for those with metastatic or refractory disease. Alterations of the PI3K/PTEN/Akt pathway have been identified in many cancers, including endometrial and ovarian cancers. Tumors with PI3K mutations have demonstrated sensitivity to this compound therefore justifying use of this agent in subjects with endometrial or ovarian, fallopian tube, or primary peritoneal cancer. Therefore use of this agent in cancer patients with PI3 kinase pathway activation offers a reasonable treatment option.

Patients will be initially treated with single agent BKM120 for 28 days at a dose of 100mg per day. CT response will be adjudged post BKM120 therapy at day 28. If there is no significant progression on CT scan, patients will be continued on BKM120 for another two cycles (28 days per cycle [+/- 3 days]). Response assessments will then be done at that time (after the third 28 day cycle). If there is no significant progression on CT scan, then the patients will continue BKM120 with response assessments using standard CT criteria every two cycles (28 days per cycle [+/- 3 days]) thereafter.

If disease progression is observed, patient will have completed the study. Patient will be seen within 30 days for end of treatment visit. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

• NCT number: NCT01550380
• Study type: Interventional
• Source: University of Utah
• Status: Withdrawn
• Phase: Phase 2
• Start date: May 2014
• Completion date: July 2014