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NCT01453595 · ClinicalTrials.gov registry record · Phase 1
BEZ235 in Patients With Advanced Renal Cell Carcinoma (RCC)
A Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT01453595: Clinical Trial Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.
NCT01453595 is a Phase 1 study that was terminated before completion, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01453595, a Phase 1 study, was terminated before completion, sponsored by Memorial Sloan Kettering Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG BEZ235
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2011-10 |
| Est. Completion | 2014-04 |
| Phase | Phase 1 |
Why NCT01453595 stopped before completion
NCT01453595 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which BEZ235 is the first listed.
NCT01453595 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01453595 about?
NCT01453595 is a clinical study titled "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. Ol...
What is the current status of trial NCT01453595?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2011-10. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01453595?
The interventions under investigation include: BEZ235 (DRUG).
Who is sponsoring clinical trial NCT01453595?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01453595's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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