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NCT00126503 · ClinicalTrials.gov registry record · Phase 1

Sorafenib Tosylate and Bevacizumab in Treating Patients With Advanced Kidney Cancer

A Phase 1 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
73
Enrollment target

NCT00126503: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).

NCT00126503 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 73 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00126503, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
73 participants
Enrollment target

Study Summary

This phase I/II trial studies the side effects and best dose of sorafenib tosylate and bevacizumab and to see how well they work in treating patients with advanced kidney cancer. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth by targeting certain cells. Bevacizumab and sorafenib tosylate may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving sorafenib tosylate together with bevacizumab may kill more tumor cells.

Primary Outcome

The highest dose in milligrams (mg) of BAY 43-9006 (Sorafenib) in combination with Bevacizumab while maintaining tolerability. Cohorts of 3-6 patients received escalating doses of sorafenib and bevacizumab until the maximum tolerated dose (MTD) was achieved. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose-limiting toxicity during the initial cycle of therapy. DLTs include absolute neutrophil count (ANC) \< 500/mm3 for \> 7 days, ANC \< 1000/mm3 with

Interventions

  • OTHER Laboratory Biomarker Analysis
  • BIOLOGICAL Bevacizumab
  • OTHER Pharmacological Study
  • DRUG Sorafenib Tosylate

Trial Details

FieldValue
Enrollment Target 73 participants
Start Date 2005-05
Est. Completion 2012-02
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00126503 record still lists

NCT00126503 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% higher).

The record links to 0 conditions, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.

NCT00126503 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00126503 about?

NCT00126503 is a clinical study titled "Sorafenib Tosylate and Bevacizumab in Treating Patients With Advanced Kidney Cancer". This phase I/II trial studies the side effects and best dose of sorafenib tosylate and bevacizumab and to see how well they work in treating patients with advanced kidney cancer. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal ...

What is the current status of trial NCT00126503?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 73 participants. The study started on 2005-05. Estimated completion is 2012-02.

What interventions are being tested in trial NCT00126503?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Bevacizumab (BIOLOGICAL), Pharmacological Study (OTHER), Sorafenib Tosylate (DRUG).

Who is sponsoring clinical trial NCT00126503?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00126503's enrollment target sits among peer trials

73 732nd of 2000 higher than 1,265 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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Source: ClinicalTrials.gov NCT00126503, the US trial registry maintained by the National Library of Medicine. NCT00126503 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.