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NCT00267748 · ClinicalTrials.gov registry record · Phase 2
Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (RCC)
A Phase 2 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 317
- Enrollment target
NCT00267748: Completed Phase 2 study, sponsored by Pfizer.
NCT00267748 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 317 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (138% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00267748, a Phase 2 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 317 participants
- Enrollment target
Study Summary
This trial has two parts. The purpose of the first part of the trial is to determine the doses of 2 drugs, sunitinib malate and interferon alfa-2b, that can be given safely in combination. This part is currently closed to enrollment. The purpose of the second part of the trial is to see if sunitinib malate given on a 4/2 schedule (4 weeks on treatment, 2 weeks off treatment cycle) is any better at delaying progression of renal cell cancer than sunitinib malate given on a continuous dosing schedule. The trial will also determine the number of patients whose cancer responds to the treatments, whether life of patients can be extended, what the side effects are of the treatments, how bothersome disease or treatment-related symptoms are to patients, and whether tests can be found that will predict which patients may or may not respond to these treatments in the future.
Primary Outcome
MSKCC Prognostic Factor Model assessed as low(0),intermediate(1-2) or high(=\>3) based on number of criteria present such as Karnofsky performance status \< 80 %, Lactate dehydrogenase \> 1.5 \* Upper limit of Normal,Hemoglobin \< lower limit of normal, serum calcium \> 10 mg/dL;Time from first diagnosis of renal cell carcinoma to start of systemic therapy of \< 1 year.TTP was time from start of study treatment to first documentation of objective tumor progression or death due to cancer.TTP was
Interventions
- DRUG Sunitinib Malate Continuous Daily Dosing
- DRUG Sunitinib Malate Schedule 4/2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 317 participants |
| Start Date | 2005-12 |
| Est. Completion | 2010-06 |
| Phase | Phase 2 |
What the finished NCT00267748 record still lists
NCT00267748 is an interventional study that assigns participants to a tested intervention. The registered 317 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (138% higher).
The record links to 0 conditions, and to 2 interventions - of which Sunitinib Malate Continuous Daily Dosing is the first listed.
NCT00267748 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00267748 about?
NCT00267748 is a clinical study titled "Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (RCC)". This trial has two parts. The purpose of the first part of the trial is to determine the doses of 2 drugs, sunitinib malate and interferon alfa-2b, that can be given safely in combination. This part is currently closed to enrollment. The purpose of the second part of the trial is to see if sunitini...
What is the current status of trial NCT00267748?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 317 participants. The study started on 2005-12. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00267748?
The interventions under investigation include: Sunitinib Malate Continuous Daily Dosing (DRUG), Sunitinib Malate Schedule 4/2 (DRUG).
Who is sponsoring clinical trial NCT00267748?
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 NCT00267748's enrollment target sits among peer trials
317 155th of 2000 higher than 1,846 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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