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Report for Clinical Trial NCT01550380

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT01550380 Endometrial Cancer
MeSH:Endometrial Neoplasms
HPO:Endometrial carcinoma

1 Interventions

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 Daily
Type: Drug
Group Labels: 1

All participants


Primary Outcomes

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 months

Secondary Outcomes

Description: 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 months

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 P13K

Exclusion Criteria: - Patients who have received prior treatment with a P13K inhibitor. --- P13K ---



HPO Nodes


HPO: