Ignite Creation Date:
2025-12-24 @ 1:52 PM
Ignite Modification Date:
2026-01-01 @ 1:51 AM
Study NCT ID:
NCT01453595
Status:
TERMINATED
Last Update Posted:
2016-02-29
First Post:
2011-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
BEZ235 in Patients With Advanced Renal Cell Carcinoma (RCC)
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Study Overview
Official Title:
A Phase 1b/2 Study of BEZ235 in Patients With Advanced Renal Cell Carcinoma (RCC)
Status:
TERMINATED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Given the number of toxicities seen and the difficulty with patient retention in the dose escalation portion, the sponsor decided to close the trial.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 \[Torisel®\] or everolimus \[Afinitor®\]) 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: