SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT01453595

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 1b/2 Study of BEZ235 in Patients With Advanced Renal Cell Carcinoma (RCC)

This study tests a new medication for treatment of kidney cancer, called BEZ235. This medication works by blocking several mechanisms that the cancer needs to grow and survive. By blocking these mechanisms, the medication can thus suppress further growth of the cancer, possibly kill cancer cells. Older kidney cancer medications (such as temsirolimus [ToriselĀ®] or everolimus [AfinitorĀ®]) typically only block one mechanism in cancer cells, so the investigators think that BEZ235 may work even better against kidney cancer. The purpose of the first part of this study is to test the safety of giving BEZ235 at different doses. The investigators are trying to find a safe dose of BEZ235 and want to find out what effects, good and/or bad, it has on the patient and the cancer.

NCT01453595 Renal Cancer
MeSH: Carcinoma Carcinoma, Renal Cell Kidney Neoplasms
HPO: Carcinoma Clear cell renal cell carcinoma Papillary renal cell carcinoma Renal cell carcinoma Renal neoplasm

1 Interventions

Name: BEZ235

Description: BEZ235 will be taken orally twice daily starting on Day 1, Cycle 1, self-administration will continue twice daily on a continuous schedule with cycle length defined as 28 days. Increasing dosing levels of BEZ235 will be studied sequentially (beginning with Dose Level 1, BEZ235 400mg by mouth twice daily) as per the treatment noted below. Cohort-1a BEZ235 300 mg by mouth twice daily Cohort 1 BEZ235 400 mg by mouth twice daily Cohort 2 BEZ235 600 mg by mouth twice daily Cohort 3 BEZ235 800 mg by mouth twice daily

Type: Drug

BEZ235


Primary Outcomes

Description: In patients with advanced clear cell RCC, progressing after prior first-line or second-line mTOR therapy. The determination of antitumor efficacy will be based on objective tumor assessments made according to the RECIST1.1.

Measure: Objective Response Rate (ORR)

Time: 1 year

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 P13K

Exclusion Criteria: - Patients who have received prior treatment with a P13K inhibitor (Phase 2 portion only). --- P13K ---



HPO Nodes


HPO:
Carcinoma
Genes 16
POLE MSH2 DKC1 SMARCA4 NLRP1 POLD1 CDKN1B MLH1 RSPO1 FGFR3 BCL10 APC STK11 PTEN APC KIT
Clear cell renal cell carcinoma
Genes 1
NOD2
Papillary renal cell carcinoma
Genes 8
MET LMNA MINPP1 FOXE1 CDC73 FH HABP2 PRCC
Renal cell carcinoma
Genes 75
CCND1 TSC2 COL14A1 VHL HNF1B MET FLCN AKT1 SDHC HABP2 SDHAF2 NRAS FLCN SRC CDC73 FH APC PRCC SLC49A4 STK11 SDHB DCC TSC1 KLLN HNF1B SLC25A11 TP53 SDHD SEC23B BAP1 PTEN HNF1A KIF1B MAX PIK3CA VHL RNF139 MINPP1 CTNNB1 BUB1 RET KEAP1 DICER1 AAGAB DLC1 FN1 PIK3CA NOD2 SDHC FGFR3 FH TMEM127 VHL FLCN VHL OGG1 EP300 FOXE1 SDHB BUB1B AXIN2 SDHA MITF SDHD TFE3 FH IFNG PTPRJ LMNA HNF4A DLST MDH2 SDHB AKT1 FLCN
Renal neoplasm
Genes 167
GPC3 REST GPC3 TSC2 VAMP7 TRIP13 HNF1B BUB1B KCNQ1OT1 SOX9 FLCN SDHC TRIM37 SDHAF2 LMNA EXT2 GATA4 TSC2 BRCA2 SRC BUB1 FH APC SLC49A4 SDHB WT1 HDAC4 SLC25A11 SDHD BAP1 ALX4 SRY VHL KLLN CTNNB1 NR5A1 KEAP1 DICER1 DIS3L2 WT1 FIBP DLC1 FN1 PIK3CA NOD2 SDHC FGFR3 VHL MAP3K1 EP300 FOXE1 WT1 AXIN2 MITF PAX6 SDHD IFNG NSD1 TBX18 H19 H19 TRIM28 MDH2 PTCH1 GPC4 MLH1 POU6F2 AKT1 WT1 CCND1 ZFPM2 H19-ICR TP53 TRIP13 GPC4 COL14A1 TRIM28 VHL WT1 MET TSC1 TRIP13 AKT1 MSH6 POU6F2 HABP2 CDC73 H19 KCNQ1OT1 H19 IGF2 NRAS BUB1B KCNQ1 FLCN CDKN1B DIS3L2 CDC73 REST PRCC IGF2 CDKN1B STK11 WT1 WT1 NR0B1 BUB3 DCC WT1 TSC1 KLLN MSH2 HNF1B TSC2 TP53 SEC23B GPC3 PTEN HNF1A KIF1B MAX DICER1 PIK3CA PIK3CA DIS3L2 RNF139 MINPP1 DMRT3 BRCA2 BUB1 RET CDKN1C AAGAB TSC1 WT1 FH GPC3 WRN PIK3CA TMEM127 VHL IGF2 FLCN H19 OGG1 SETBP1 SDHB BUB1B SDHA IGF2 CEP57 TFE3 FH CDC73 GPC4 DICER1 PTPRJ LMNA HNF4A DLST H19 SDHB BMPER PALB2 FLCN PHF21A WWOX