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NCT00126594 · ClinicalTrials.gov registry record · Phase 2
Sorafenib Tosylate With or Without Recombinant Interferon Alfa-2b in Treating Patients With Metastatic Kidney Cancer
A Phase 2 study of Clear Cell Renal Cell Carcinoma and Stage IV Renal Cell Cancer, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT00126594: Completed Phase 2 study of Clear Cell Renal Cell Carcinoma and Stage IV Renal Cell Cancer, sponsored by National Cancer Institute (NCI).
NCT00126594 is a Phase 2 study of Clear Cell Renal Cell Carcinoma and Stage IV Renal Cell Cancer that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 80 participants, below the 201-participant average among 45 other Clear Cell Renal Cell Carcinoma trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00126594, a Phase 2 study of Clear Cell Renal Cell Carcinoma and Stage IV Renal Cell Cancer, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
This randomized phase II trial is studying sorafenib and interferon alfa-2b to see how well they work compared to sorafenib alone in treating patients with metastatic kidney cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Interferon alfa-2b may interfere with the growth of tumor cells. Sorafenib and interferon alfa-2b may also block blood flow to the tumor. Giving sorafenib together with interferon alfa-2b may kill more tumor cells.
Primary Outcome
ORR defined as participants with Complete Response (CR) and Partial Response (PR) as defined by RECIST criteria: Complete Response (CR): Disappearance all target lesions. Partial Response (PR): \>30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD. Progressive Disease (PD): \>20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of one or more new lesions. Stable Disease (SD): Neither sufficient
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Recombinant Interferon Alfa-2b
- DRUG Sorafenib Tosylate
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2005-06 |
| Est. Completion | 2013-08 |
| Phase | Phase 2 |
What the finished NCT00126594 record still lists
NCT00126594 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 201-participant average among 45 other Clear Cell Renal Cell Carcinoma trials with a reported enrollment target (60% lower).
The record links to 3 conditions, with Clear Cell Renal Cell Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT00126594 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT00126594 about?
NCT00126594 is a clinical study titled "Sorafenib Tosylate With or Without Recombinant Interferon Alfa-2b in Treating Patients With Metastatic Kidney Cancer". This randomized phase II trial is studying sorafenib and interferon alfa-2b to see how well they work compared to sorafenib alone in treating patients with metastatic kidney cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Interferon alfa-2...
What is the current status of trial NCT00126594?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2005-06. Estimated completion is 2013-08.
What conditions does trial NCT00126594 study?
This clinical trial studies the following conditions: Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer, Recurrent Renal Cell Carcinoma.
What interventions are being tested in trial NCT00126594?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Recombinant Interferon Alfa-2b (BIOLOGICAL), Sorafenib Tosylate (DRUG).
Who is sponsoring clinical trial NCT00126594?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00126594 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00126594's enrollment target sits among peer trials
80 23rd of 45 higher than 23 of 45 other Clear Cell Renal Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Clear Cell Renal Cell Carcinoma 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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