SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT01453595

Developed by Shray Alag, 2019.
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 11
PTEN CDKN1B APC MLH1 MSH2 FGFR3 KIT DKC1 RSPO1 STK11 NLRP1
Clear cell renal cell carcinoma
Genes 1
NOD2
Papillary renal cell carcinoma
Genes 8
FOXE1 LMNA HABP2 CDC73 MET MINPP1 PRCC FH
Renal cell carcinoma
Genes 52
FOXE1 VHL MET STK11 HNF1A HNF1B KLLN DLC1 NRAS FN1 LMNA SDHAF2 PIK3CA PRCC MAX KIF1B SRC SLC49A4 BUB1B APC FLCN COL14A1 AKT1 TSC1 TSC2 HABP2 FGFR3 CDC73 KEAP1 MINPP1 CTNNB1 RET DCC FH MDH2 PTEN RNF139 HNF4A AAGAB TMEM127 OGG1 DICER1 EP300 SEC23B SDHA SDHB TFE3 SDHC SDHD AXIN2 BAP1 NOD2
Renal neoplasm
Genes 99
FOXE1 CDKN1B CDKN1C VHL SOX9 H19-ICR HNF1A HNF1B POU6F2 DIS3L2 WWOX NRAS HDAC4 FN1 MAX KIF1B SRC WRN GATA4 WT1 APC NSD1 SRY TSC1 TSC2 EXT2 MSH2 KEAP1 MINPP1 REST RET DCC MDH2 PTCH1 PTEN HNF4A AAGAB TMEM127 TRIP13 OGG1 DICER1 ALX4 PALB2 PHF21A MAP3K1 TFE3 ZFPM2 AXIN2 BAP1 NOD2 TBX18 MET STK11 MSH6 KLLN IGF2 DLC1 DMRT3 GPC3 LMNA BRCA2 SDHAF2 PIK3CA PRCC TRIM28 SETBP1 BUB1 SLC49A4 BUB1B VAMP7 NR0B1 GPC4 MLH1 FIBP KCNQ1 FLCN COL14A1 AKT1 HABP2 NR5A1 FGFR3 PAX6 CDC73 BMPER CTNNB1 FH BUB3 RNF139 CEP57 KCNQ1OT1 TRIM37 EP300 SEC23B H19 SDHA TP53 SDHB SDHC SDHD