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NCT00113529 · ClinicalTrials.gov registry record · Phase 1
Study Of SU011248 Plus Gefitinib (Iressa) In Patients With Advanced Renal Cell Carcinoma
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
NCT00113529: Completed Phase 1 study, sponsored by Pfizer.
NCT00113529 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 42 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00113529, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
Study Summary
To assess the maximum tolerated dose and overall safety and tolerability of sunitinib \[SU011248\] administered in combination with gefitinib (Iressa) for the treatment of patients with metastatic renal cell carcinoma (Phase 1). To assess antitumor activity of the combination of gefitinib and sunitinib (Phase 2).
Primary Outcome
Objective disease response = subjects with confirmed complete response (CR) or partial response (PR) according to RECIST. A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Interventions
- DRUG Gefitinib + Sunitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2004-10 |
| Est. Completion | 2008-10 |
| Phase | Phase 1 |
What the finished NCT00113529 record still lists
NCT00113529 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 1 intervention - of which Gefitinib + Sunitinib is the first listed.
NCT00113529 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00113529 about?
NCT00113529 is a clinical study titled "Study Of SU011248 Plus Gefitinib (Iressa) In Patients With Advanced Renal Cell Carcinoma". To assess the maximum tolerated dose and overall safety and tolerability of sunitinib \[SU011248\] administered in combination with gefitinib (Iressa) for the treatment of patients with metastatic renal cell carcinoma (Phase 1). To assess antitumor activity of the combination of gefitinib and suniti...
What is the current status of trial NCT00113529?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2004-10. Estimated completion is 2008-10.
What interventions are being tested in trial NCT00113529?
The interventions under investigation include: Gefitinib + Sunitinib (DRUG).
Who is sponsoring clinical trial NCT00113529?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00113529's enrollment target sits among peer trials
42 1105th of 2000 higher than 876 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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