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Report for Clinical Trial NCT02117817

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase I Trial of BKM120 in Combination With Weekly Nabpaclitaxel (Abraxane®) in Patients With Advanced Solid Tumors Followed by a Dose Expansion Phase in Patients With Recurrent Endometrial or Recurrent Ovarian Cancer

The purpose of the first part of this study or the dose escalation portion of the study is to determine what dose of BKM120 and Abraxane is safe to give when the two drugs are used at the same time in patients who are diagnosed with a solid cancer. A solid cancer is a cancer that does not involve the blood, bone marrow or lymph nodes. Dose escalation determines the least toxic and most effect dose of this drug combination for treatment. Once this dose is established, it will be used for the dose expansion phase of the study where we will determine the effect of BKM120 and Abraxane in women diagnosed with a recurrent endometrial or ovarian cancer. We will see whether the combination of both drugs improves the response and survival of patients treated on the two drug regimen. Also we will try to find out whether there are changes in tumors that can help us determine what patients are more likely to respond to BKM120 and Abraxane.

NCT02117817 Ovarian Cancer Endometrial Cancer Recurrent Ovarian Cancer Recurrent Endometrial Cancer
MeSH: Ovarian Neoplasms Carcinoma, Ovarian Epithelial Endometrial Neoplasms
HPO: Endometrial carcinoma Ovarian neoplasm

2 Interventions

Name: BKM120

Type: Drug

Treatment (BKM120 in Combination with Weekly Nabpaclitaxel)

Name: Nabpaclitaxel

Description: Given IV

Type: Drug

Treatment (BKM120 in Combination with Weekly Nabpaclitaxel)


Primary Outcomes

Measure: Incidence of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Time: 2 years

Secondary Outcomes

Measure: Response rate (at the end of the 3 months of therapy)

Time: 2 years

Measure: Time to progressive disease

Time: 2 years

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 P13K

- Ability to sign informed consent - INR ≤ 1.5 Exclusion Criteria: - Patients who have received prior treatment with a P13K inhibitor. --- P13K ---



HPO Nodes


HPO:
Endometrial carcinoma
Genes 23
PMS2 SDHB CDH1 GREM1 POLD1 NTHL1 MSH6 BMPR1A POLE SDHC KLLN MSH2 MSH6 SDHD SEC23B MSH6 PTEN MLH1 POLD1 PIK3CA MLH3 AKT1 MSH3
Ovarian neoplasm
Genes 86
VAMP7 ZFPM2 CTNNB1 PTEN AKT1 WT1 FGFR2 AKT1 OPCML SOX9 BRCA2 BRCA1 PTEN MLH1 SUFU EWSR1 PMS2 IDH1 LMNA RAD51C RAD51C STAG3 GATA4 PALLD PIK3CA CHEK2 BRIP1 MRE11 FGFR2 TP53 RAD51D PRKN MSH6 EPCAM WT1 NR0B1 WT1 KRAS DICER1 TGFBR2 IDH2 SRY BRCA1 FAN1 DMRT3 MSH3 TP53 KRAS NR5A1 INHBA RNF43 KEAP1 DICER1 BARD1 SMAD4 RAD50 MSH2 NBN WNT10A C11ORF95 MLH3 PTCH2 CDH1 WRN PTEN PALB2 MAP3K1 PIK3CA RELA MAP3K1 PALB2 WT1 PMS2 BRCA2 PTEN BRCA1 RAD51 BRCA1 BRCA2 PTCH1 FLI1 PTEN PMS1 PTCH1 CDKN2A WWOX