Phase 2 Multicenter Study to Assess the Safety and Efficacy of BKM120 as Monotherapy in Treatment of Initial or Recurrent Metastatic Endometrial Cancer After 1st Line Therapy in Patients Who Cannot Undergo Local Surgery and/or Radiotherapy (ENDOPIK)

NCT01397877 Phase 2 COMPLETED

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

Details

Lead sponsor	ARCAGY/ GINECO GROUP
Phase	Phase 2
Status	COMPLETED
Enrolment	24
Start date	2011-12
Completion	2016-03

Conditions

• Endometrial Cancer

Interventions

• BKM120

Primary outcomes

• Clinical Efficacy — 3 months
  To determine the clinical efficacy of BKM120 as monotherapy in the treatment of initial or recurrent metastatic endometrial cancer after first line radio chemotherapy.

Countries

France