Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01058655 · ClinicalTrials.gov registry record · Phase 1
RAD001 and AV-951 in Patients With Refractory, Metastatic Colorectal Cancer
A Phase 1 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
NCT01058655: Completed Phase 1 study, sponsored by Dana-Farber Cancer Institute.
NCT01058655 is a Phase 1 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 56 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01058655, a Phase 1 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
Study Summary
Research has shown that anti-angiogenic agents can be effective therapies to treat cancer. Anti-angiogenic agents target the blood vessels required for tumors to grow. Vascular endothelial growth factor (VEGF) is one of the cell pathways used for this blood vessel growth. When the investigators interfere with the VEGF pathway, the investigators inhibit this blood vessel growth which is required by tumors. One of the study drugs being used, tivozanib (AV-951), selectively interferes with the VEGF pathway. The second study drug being used, everolimus (RAD001) interferes with the mTOR pathway. The mTOR pathway is another pathway involved in blood vessel and tumor cell growth. By combining these two drugs the investigators hope to slow or reverse tumor cell growth in patients whose tumors have become resistant to other therapies for their disease.
Primary Outcome
The everolimus MTD in combination with tivozanib is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached.
Interventions
- DRUG Everolimus
- DRUG Tivozanib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2010-02 |
| Est. Completion | 2015-04 |
| Phase | Phase 1 |
What the finished NCT01058655 record still lists
NCT01058655 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Everolimus is the first listed.
NCT01058655 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01058655 about?
NCT01058655 is a clinical study titled "RAD001 and AV-951 in Patients With Refractory, Metastatic Colorectal Cancer". Research has shown that anti-angiogenic agents can be effective therapies to treat cancer. Anti-angiogenic agents target the blood vessels required for tumors to grow. Vascular endothelial growth factor (VEGF) is one of the cell pathways used for this blood vessel growth. When the investigators inte...
What is the current status of trial NCT01058655?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2010-02. Estimated completion is 2015-04.
What interventions are being tested in trial NCT01058655?
The interventions under investigation include: Everolimus (DRUG), Tivozanib (DRUG).
Who is sponsoring clinical trial NCT01058655?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01058655's enrollment target sits among peer trials
56 902nd of 2000 higher than 1,083 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02287428 · 56 participants · Phase 1
Personalized NeoAntigen Cancer Vaccine w RT Plus Pembrolizumab for Patients With Newly Diagnosed GBM
- NCT02923011 · 56 participants · Phase 3
Comparative Effectiveness of MRgFUS Versus CTgRFA for Osteoid Osteomas
- NCT02935283 · 56 participants
Neuroimaging and Neuropsychological Outcomes in Urea Cycle Disorders
- NCT03375866 · 56 participants · NA
Effects of Mixed Nut Consumption on Satiety and Weight Management
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia