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NCT00137423 · ClinicalTrials.gov registry record · Phase 2
Study Of SU011248 (Sunitinib) Given In A Continuous Daily Regimen In Patients With Advanced Renal Cell Cancer
A Phase 2 study of Carcinoma, Renal Cell Metastasis, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 107
- Enrollment target
- 10
- Study locations
NCT00137423: Completed Phase 2 study of Carcinoma, Renal Cell Metastasis, sponsored by Pfizer.
NCT00137423 is a Phase 2 study of Carcinoma, Renal Cell Metastasis that has completed, run by Pfizer. The registered enrollment target is 107 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% lower). The trial reports 10 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00137423, a Phase 2 study of Carcinoma, Renal Cell Metastasis, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 107 participants
- Enrollment target
- 10
- Study locations
Study Summary
To evaluate the anti-tumor activity of SU011248 (sunitinib) in cytokine-refractory metastatic renal cell carcinoma (RCC) when administered in a continuous treatment regimen
Primary Outcome
Confirmed objective responses using RECIST criteria defined as responses persisting on repeat imaging study for 2 assessments with at least 4 weeks between, and evaluating all target and non-target sites followed since baseline. Two PRs separated by an SD or NE visit in between was considered a confirmed response if the 2 PRs were \> 4 weeks apart. CR=disappearance of all target lesions. PR is a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the
Conditions Studied
Interventions
- DRUG SU011248 (sunitinib)
Study Locations (10)
Other
- Pfizer Investigational Site - Villejuif
- Pfizer Investigational Site - Berlin
- Pfizer Investigational Site - München
- Pfizer Investigational Site - Thessaloniki
- Pfizer Investigational Site - Lund
- Pfizer Investigational Site - Stockholm
- Pfizer Investigational Site - Sankt Gallen
California
- Pfizer Investigational Site - Stanford
Nevada
- Pfizer Investigational Site - Las Vegas
Gelderland
- Pfizer Investigational Site - Nijmegen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2005-05 |
| Est. Completion | 2008-05 |
| Phase | Phase 2 |
What the finished NCT00137423 record still lists
NCT00137423 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% lower).
The record links to 1 condition, with Carcinoma, Renal Cell Metastasis appearing as the primary indexed condition, and to 1 intervention - of which SU011248 (sunitinib) is the first listed.
NCT00137423 lists 10 locations in 4 states (Other, California, Nevada).
Frequently Asked Questions
What is clinical trial NCT00137423 about?
NCT00137423 is a clinical study titled "Study Of SU011248 (Sunitinib) Given In A Continuous Daily Regimen In Patients With Advanced Renal Cell Cancer". To evaluate the anti-tumor activity of SU011248 (sunitinib) in cytokine-refractory metastatic renal cell carcinoma (RCC) when administered in a continuous treatment regimen
What is the current status of trial NCT00137423?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 107 participants. The study started on 2005-05. Estimated completion is 2008-05.
What conditions does trial NCT00137423 study?
This clinical trial studies the following conditions: Carcinoma, Renal Cell Metastasis.
What interventions are being tested in trial NCT00137423?
The interventions under investigation include: SU011248 (sunitinib) (DRUG).
Who is sponsoring clinical trial NCT00137423?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00137423 being conducted?
This trial has 10 study locations across California, Nevada, Gelderland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00137423's enrollment target sits among peer trials
107 646th of 2000 higher than 1,353 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
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