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NCT00664326 · ClinicalTrials.gov registry record · Phase 2
A Phase II Uncontrolled Study of BAY73-4506 in Previously Untreated Patients With Metastatic or Unresectable RCC
A Phase 2 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 2
- Development phase
- 49
- Enrollment target
NCT00664326: Completed Phase 2 study, sponsored by Bayer.
NCT00664326 is a Phase 2 study that has completed, run by Bayer. The registered enrollment target is 49 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00664326, a Phase 2 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 49 participants
- Enrollment target
Study Summary
This is a uncontrolled, open-label, non-randomized Phase II study of oral BAY73-4506 to evaluate the response rate of BAY73-4506 in previously untreated patients with metastatic or unresectable renal cell cancer (RCC).
Primary Outcome
Objective tumor response of a participant was defined as the best tumor response (confirmed Complete Response \[CR, tumor disappears\] or Partial Response \[PR, sum of lesion sizes decreased at least 30% from baseline\]) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) committee.
Interventions
- DRUG Regorafenib (Stivarga, BAY73-4506)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2008-04-30 |
| Est. Completion | 2019-04-02 |
| Phase | Phase 2 |
What the finished NCT00664326 record still lists
NCT00664326 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 1 intervention - of which Regorafenib (Stivarga, BAY73-4506) is the first listed.
NCT00664326 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00664326 about?
NCT00664326 is a clinical study titled "A Phase II Uncontrolled Study of BAY73-4506 in Previously Untreated Patients With Metastatic or Unresectable RCC". This is a uncontrolled, open-label, non-randomized Phase II study of oral BAY73-4506 to evaluate the response rate of BAY73-4506 in previously untreated patients with metastatic or unresectable renal cell cancer (RCC).
What is the current status of trial NCT00664326?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2008-04-30. Estimated completion is 2019-04-02.
What interventions are being tested in trial NCT00664326?
The interventions under investigation include: Regorafenib (Stivarga, BAY73-4506) (DRUG).
Who is sponsoring clinical trial NCT00664326?
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 NCT00664326's enrollment target sits among peer trials
49 1261st of 2000 higher than 736 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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