SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02117817

Developed by Shray Alag, 2019.
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 19
PTEN MLH1 CDH1 PIK3CA MSH6 AKT1 POLD1 BMPR1A NTHL1 POLE SEC23B PMS2 MSH2 KLLN MSH3 SDHB SDHC SDHD GREM1
Ovarian neoplasm
Genes 63
RAD51 RAD51C PMS1 RAD51D CDKN2A KRAS SOX9 TGFBR2 FLI1 MRE11 MSH6 PMS2 MLH3 BRIP1 DMRT3 WWOX BRCA1 LMNA BRCA2 INHBA PIK3CA VAMP7 NR0B1 WRN CHEK2 GATA4 WT1 PTCH2 BARD1 MLH1 WNT10A NBN AKT1 C11ORF95 PRKN SRY EWSR1 RELA NR5A1 MSH2 MSH3 FGFR2 KEAP1 IDH1 IDH2 CTNNB1 PTCH1 PTEN SUFU CDH1 EPCAM DICER1 STAG3 RNF43 PALLD PALB2 OPCML TP53 MAP3K1 ZFPM2 SMAD4 FAN1 RAD50