GINECO-EN102b - BKM120 as Monotherapy in the Treatment of Initial or Recurrent Metastatic Endometrial Cancer
Status:
Completed
Trial end date:
2016-03-01
Target enrollment:
Participant gender:
Summary
This study is to determine the clinical efficacy of BKM120 as monotherapy in the treatment of
initial or recurrent metastatic endometrial cancer after first line radio chemotherapy.
Clinical efficacy will be determined by the non-progression rate at 3 or 2 months depending
on the group of patients. The primary endpoint is the non-progression rate at 3 months (12
weeks) for the patient group whose disease is painless (low grade tumor = stratum 1) and the
non-progression rate at 2 months (8 weeks) for the group of patients with an aggressive
disease (high grade tumor = stratum 2).
Disease progression is defined by the RECIST 1.1 criteria