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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
Group Labels: 1

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

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 (Phase 2 portion only). --- P13K ---



HPO Nodes


HPO: