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NCT01047293 · ClinicalTrials.gov registry record · Phase 1
RAD001, FOLFOX and Bevacizumab in Treatment of Colorectal Carcinoma
A Phase 1 study of Colorectal Cancer, sponsored by University of Utah.
- Completed
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
- 2
- Study locations
NCT01047293: Completed Phase 1 study of Colorectal Cancer, sponsored by University of Utah.
NCT01047293 is a Phase 1 study of Colorectal Cancer that has completed, run by University of Utah. The registered enrollment target is 47 participants, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01047293, a Phase 1 study of Colorectal Cancer, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
- 2
- Study locations
Study Summary
RAD001 (everolimus) is a novel oral derivative of rapamycin. RAD001 has been in clinical development since 1996 as an immunosuppressant in solid organ transplantation and has obtained marketing authorization (Certican®) for prophylaxis of rejection in renal and cardiac transplantation in a number of countries, including the majority of the European Union. RAD001 has been in development for patients with various malignancies since 2002. RAD001 is being investigated as an anticancer agent based on its potential to act: * Directly on the tumor cells by inhibiting tumor cell growth and proliferation * Indirectly by inhibiting angiogenesis leading to reduced tumor vascularity (via potent inhibition of tumor cell HIF-1 activity, VEGF production and VEGF-induced proliferation of endothelial cells). The role of angiogenesis in the maintenance of solid tumor growth is well established, and the mTOR pathway has been implicated in the regulation of tumor production of proangiogenic factors as well as modulation of VEGFR signaling in endothelial cells. At weekly and daily schedules and at various doses explored, RAD001 is generally well tolerated. The most frequent adverse events (rash, mucositis, fatigue and headache) associated with RAD001 therapy are manageable. Non-infectious pneumonitis has been reported with mTOR inhibitors but is commonly low-grade and reversible. Both FOLFOX and bevacizumab are well established for treatment of metastatic colorectal carcinomas. FOLFOX-6 can be combined safely with Bevacizumab and is currently in phase 3 testing for adjuvant therapy and is commonly used as a first line treatment regimen for metastatic colorectal cancers 25. There is an enhanced interest in development of more effective regimens for colorectal cancers. RAD001 is a mTOR inhibitor that has preclinical and clinical activity in colorectal cancers. RAD001 downregulates the mTOR pathway which can lead to direct antiproliferative effects as well as decreased production of Va
Conditions Studied
Interventions
- DRUG Bevacizumab
- DRUG FOLFOX
- DRUG RAD001
Study Locations (2)
Utah
- Huntsman Cancer Institute - Salt Lake City
- Utah Cancer Specialists - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2010-05 |
| Est. Completion | 2015-08 |
| Phase | Phase 1 |
What the finished NCT01047293 record still lists
NCT01047293 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Colorectal Cancer appearing as the primary indexed condition, and to 3 interventions - of which Bevacizumab is the first listed.
NCT01047293 reports a single indexed study location in Utah.
Frequently Asked Questions
What is clinical trial NCT01047293 about?
NCT01047293 is a clinical study titled "RAD001, FOLFOX and Bevacizumab in Treatment of Colorectal Carcinoma". RAD001 (everolimus) is a novel oral derivative of rapamycin. RAD001 has been in clinical development since 1996 as an immunosuppressant in solid organ transplantation and has obtained marketing authorization (Certican®) for prophylaxis of rejection in renal and cardiac transplantation in a number of...
What is the current status of trial NCT01047293?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2010-05. Estimated completion is 2015-08.
What conditions does trial NCT01047293 study?
This clinical trial studies the following conditions: Colorectal Cancer.
What interventions are being tested in trial NCT01047293?
The interventions under investigation include: Bevacizumab (DRUG), FOLFOX (DRUG), RAD001 (DRUG).
Who is sponsoring clinical trial NCT01047293?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01047293 being conducted?
This trial has 2 study locations across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01047293's enrollment target sits among peer trials
47 282nd of 381 higher than 99 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer 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.
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