Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01108445 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of Afinitor vs. Sutent in Patients With Metastatic Non-Clear Cell Renal Cell Carcinoma
A Phase 2 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 2
- Development phase
- 131
- Enrollment target
NCT01108445: Completed Phase 2 study, sponsored by Duke University.
NCT01108445 is a Phase 2 study that has completed, run by Duke University. The registered enrollment target is 131 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01108445, a Phase 2 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 131 participants
- Enrollment target
Study Summary
To compare the anti-tumor activity of everolimus and sunitinib in subjects with metastatic renal cell carcinoma (mRCC) with non-clear cell pathology.
Primary Outcome
The primary objective will be to compare the anti-tumor activity of everolimus and sunitinib in subjects with mRCC with non-clear cell pathology, as measured by progression-free survival (PFS) following treatment initiation according to RECIST 1.1 criteria. Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. In addition to the re
Interventions
- DRUG Everolimus
- DRUG Sunitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2010-09 |
| Est. Completion | 2015-04 |
| Phase | Phase 2 |
What the finished NCT01108445 record still lists
NCT01108445 is an interventional study that assigns participants to a tested intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Everolimus is the first listed.
NCT01108445 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01108445 about?
NCT01108445 is a clinical study titled "Phase II Study of Afinitor vs. Sutent in Patients With Metastatic Non-Clear Cell Renal Cell Carcinoma". To compare the anti-tumor activity of everolimus and sunitinib in subjects with metastatic renal cell carcinoma (mRCC) with non-clear cell pathology.
What is the current status of trial NCT01108445?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 131 participants. The study started on 2010-09. Estimated completion is 2015-04.
What interventions are being tested in trial NCT01108445?
The interventions under investigation include: Everolimus (DRUG), Sunitinib (DRUG).
Who is sponsoring clinical trial NCT01108445?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01108445's enrollment target sits among peer trials
131 541st of 2000 higher than 1,458 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
- NCT03051464 · 131 participants · Phase 2
No Surgery Trial / Two Dose-escalation Strategies
- NCT04301843 · 131 participants · Phase 2
Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma
- NCT04748549 · 131 participants · NA
Intraoperative VR for Older Patients Undergoing TKA
- NCT05951179 · 131 participants · Phase 2
Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer
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