CI

At a glance

ClinicalIndex Comparison Record
Phase 2Terminated· 10 enrolled
Drug / intervention
sorafenib tosylate +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00126659
NCT00126659Phase 2Terminated
Terminated
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A Phase II Neoadjuvant Clinical Trial to Evaluate the Efficacy of BAY 43-9006 (Sorafenib) in Metastatic Renal Cell Carcinoma

National Cancer Institute (NCI)·interventional·Posted Aug 4, 2005·Updated Nov 20, 2018

In Brief

A Phase 2 clinical trial evaluating therapeutic conventional surgery, sorafenib tosylate, and 1 other intervention for Clear Cell Renal Cell Carcinoma and 2 related conditions. Terminated early, enrolled 10 participants across 1 site.

Signals

Trial was terminated early

Detailed Summary

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. Giving sorafenib before and after surgery may be an effective treatment for kidney cancer. This phase II trial is studying how well sorafenib works in treating patients who are undergoing surgery for metastatic kidney cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsClear Cell Renal Cell Carcinoma, Recurrent Renal Cell Cancer, Stage IV Renal Cell Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2TerminatedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 4, 2005
Enrollment StartJan 1, 2006
Primary CompletionDec 1, 2009
TodayJul 1, 2026
Enrollment to primary: 3.9 yearsPosted 20.9 years ago

Interventions

therapeutic conventional surgeryprocedure

Undergo cytoreductive nephrectomy

sorafenib tosylatedrug

Given orally

laboratory biomarker analysisother

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