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NCT00117637 · ClinicalTrials.gov registry record · Phase 2
BAY43-9006 (Sorafenib) Versus Interferon Alpha-2a in Patients With Unresectable and/or Metastatic Renal Cell Carcinoma
A Phase 2 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 2
- Development phase
- 189
- Enrollment target
NCT00117637: Completed Phase 2 study, sponsored by Bayer.
NCT00117637 is a Phase 2 study that has completed, run by Bayer. The registered enrollment target is 189 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (42% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00117637, a Phase 2 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 189 participants
- Enrollment target
Study Summary
The purpose of the study is to: * Find out if patients receiving BAY43-9006 will live longer without tumor progression than those receiving standard therapy with interferon alpha-2a * Find out if a higher dose of BAY43-9006 can inhibit tumor progression in patients who progressed during standard dose treatment with BAY43-9006, and for how long these patients live without progression * Find out how long patients live without progression who receive BAY43-9006 after failing to respond to standard therapy with interferon alpha-2a * Find out in how many percent of patients BAY43-9006 prevents the growth of or shrinks kidney tumors and/or their metastases depending on treatment and dosage * Find out if BAY43-9006 has any effect on the quality of life of patients with kidney cancer * Find out the level of BAY43-9006 in the blood once per month and any changes in this level * Find out whether BAY43-9006 effects are associated with specific biomarkers
Primary Outcome
Progression-free Survival (PFS) was defined as the time from date of randomization to disease progression (radiological or clinical or death due to any cause, whichever occurs first). Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation
Interventions
- DRUG Sorafenib (Nexavar, BAY43-9006)
- DRUG Interferon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 189 participants |
| Start Date | 2005-06 |
| Est. Completion | 2009-03 |
| Phase | Phase 2 |
What the finished NCT00117637 record still lists
NCT00117637 is an interventional study that assigns participants to a tested intervention. The registered 189 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 (42% higher).
The record links to 0 conditions, and to 2 interventions - of which Sorafenib (Nexavar, BAY43-9006) is the first listed.
NCT00117637 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00117637 about?
NCT00117637 is a clinical study titled "BAY43-9006 (Sorafenib) Versus Interferon Alpha-2a in Patients With Unresectable and/or Metastatic Renal Cell Carcinoma". The purpose of the study is to: * Find out if patients receiving BAY43-9006 will live longer without tumor progression than those receiving standard therapy with interferon alpha-2a * Find out if a higher dose of BAY43-9006 can inhibit tumor progression in patients who progressed during standard do...
What is the current status of trial NCT00117637?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 189 participants. The study started on 2005-06. Estimated completion is 2009-03.
What interventions are being tested in trial NCT00117637?
The interventions under investigation include: Sorafenib (Nexavar, BAY43-9006) (DRUG), Interferon (DRUG).
Who is sponsoring clinical trial NCT00117637?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00117637's enrollment target sits among peer trials
189 355th of 2000 higher than 1,645 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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