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.
Name: BKM120
Description: NVP-BKM120 (BKM120) is an oral pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor belonging to the 2,6-dimorpholino pyrimidine derivative family.Supplied in 10mg or 50mg capsules. Starting dose: 100mg Once DailyType: DrugAll participants
Description: To assess response rate in patients with endometrial cancer treated with first line BKM120. To assess response rate in patients with ovarian, fallopian tube, and primary peritoneal cancer treated with first line BKM120.
Measure: Response Rates of BKM120 Time: Up to 20 monthsDescription: To determine the progression free survival (PFS) in patients with endometrial cancer treated with first line BKM120. To document the non-progression rate at 12 weeks in patients with endometrial cancer treated with first line BKM120. To determine the progression free survival (PFS) in patients with ovarian, fallopian tube, and primary peritoneal cancer treated with first line BKM120. To document the non-progression rate at 12 weeks in patients with ovarian, fallopian tube, and primary peritoneal cancer treated with first line BKM120.
Measure: Progression Free Survival (PFS) Time: Up to 20 monthsSingle Group Assignment
There is one SNP
Exclusion Criteria: - Patients who have received prior treatment with a P13K inhibitor. --- P13K ---