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NCT00121251 · ClinicalTrials.gov registry record · Phase 1
Sorafenib, Gemcitabine, and Capecitabine in Treating Patients With Unresectable and/or Metastatic Kidney Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT00121251: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00121251 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00121251, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
This phase I/II trial is studying the side effects and best dose of sorafenib, gemcitabine, and capecitabine and to see how well they work in treating patients with unresectable and/or metastatic kidney cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with gemcitabine and capecitabine may kill more tumor cells.
Primary Outcome
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR
Interventions
- DRUG Capecitabine
- DRUG Gemcitabine Hydrochloride
- DRUG Sorafenib Tosylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2005-06-03 |
| Est. Completion | 2017-03-14 |
| Phase | Phase 1 |
What the finished NCT00121251 record still lists
NCT00121251 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 3 interventions - of which Capecitabine is the first listed.
NCT00121251 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00121251 about?
NCT00121251 is a clinical study titled "Sorafenib, Gemcitabine, and Capecitabine in Treating Patients With Unresectable and/or Metastatic Kidney Cancer". This phase I/II trial is studying the side effects and best dose of sorafenib, gemcitabine, and capecitabine and to see how well they work in treating patients with unresectable and/or metastatic kidney cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for c...
What is the current status of trial NCT00121251?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2005-06-03. Estimated completion is 2017-03-14.
What interventions are being tested in trial NCT00121251?
The interventions under investigation include: Capecitabine (DRUG), Gemcitabine Hydrochloride (DRUG), Sorafenib Tosylate (DRUG).
Who is sponsoring clinical trial NCT00121251?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00121251's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 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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