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NCT00557830 · ClinicalTrials.gov registry record · Phase 2
Randomized Study of Sorafenib Dose Escalation in Patients With Previously Untreated Metastatic Renal Cell Carcinoma
A Phase 2 study, sponsored by Accelerated Community Oncology Research Network.
- Terminated
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT00557830: Clinical Trial Phase 2 study, sponsored by Accelerated Community Oncology Research Network.
NCT00557830 is a Phase 2 study that was terminated before completion, run by Accelerated Community Oncology Research Network. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00557830, a Phase 2 study, was terminated before completion, sponsored by Accelerated Community Oncology Research Network.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
The primary objective of this study is to compare the effectiveness of a dose-escalation regimen (400 to 800mg bid) relative to the standard dosing regimen (400mg bid) of sorafenib given in patients with metastatic RCC. The secondary objectives are to evaluate the effects of the dose-escalation regimen on the quality of life (QoL) of patients with metastatic RCC and to characterize the safety and tolerability profile of a dose-escalation regimen of sorafenib in patients with metastatic RCC.
Primary Outcome
Response was evaluated via changes from baseline in radiological tumor measurements performed every 8 weeks and at the end of treatment unless clinically indicated prior to that. Confirmatory scans were to be obtained no less than 4 weeks but no more than 6 weeks following initial documentation of objective response. Response was evaluated using RECIST criteria, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is \>=30% decrease in the sum of the lon
Interventions
- DRUG Sorafenib Escalated Dose
- DRUG Sorafenib Standard Dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2008-01 |
| Est. Completion | 2011-04 |
| Phase | Phase 2 |
Why NCT00557830 stopped before completion
NCT00557830 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Sorafenib Escalated Dose is the first listed.
NCT00557830 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00557830 about?
NCT00557830 is a clinical study titled "Randomized Study of Sorafenib Dose Escalation in Patients With Previously Untreated Metastatic Renal Cell Carcinoma". The primary objective of this study is to compare the effectiveness of a dose-escalation regimen (400 to 800mg bid) relative to the standard dosing regimen (400mg bid) of sorafenib given in patients with metastatic RCC. The secondary objectives are to evaluate the effects of the dose-escalation reg...
What is the current status of trial NCT00557830?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2008-01. Estimated completion is 2011-04.
What interventions are being tested in trial NCT00557830?
The interventions under investigation include: Sorafenib Escalated Dose (DRUG), Sorafenib Standard Dose (DRUG).
Who is sponsoring clinical trial NCT00557830?
This trial is sponsored by Accelerated Community Oncology Research Network, which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00557830's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 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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