Clinical trial · Interventional
Treatment Protocol for the Use of Sorafenib in Patients With Advanced Renal Cell Carcinoma
Open Label, Non-Comparative Treatment Protocol for the Use of Sorafenib in Patients With Advanced Renal Cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This treatment protocol allows doctors to treat advanced kidney cancer with an investigational drug called sorafenib, BAY43-9006, which is being studied in clinical trials for kidney cancer and other kinds of cancer. This treatment protocol is not a clinical trial in which sorafenib is compared to another equal treatment. All patients in this protocol will be treated with sorafenib. In addition, data from the patients who participate in this protocol will provide additional information about the drug.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Renal Cell | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- interventionNames
- Drug: Sorafenib (Nexavar, BAY43-9006)
Primary outcomes (1)
- measure
- Safety parameters
- timeFrame
- From signing consent to 30 days after last dose of study drug
Secondary outcomes (1)
- measure
- Limited radiological evaluations
- timeFrame
- At baseline, than every 8 weeks after start of sorafenib
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with advanced (unresectable, recurrent or metastatic) RCC * Patients reasonably likely to benefit from treatment with sorafenib as a single agent therapy * Patients with an ECOG performance status of 0-2 * Patients who will not require other systemic anticancer therapy (except for bisphosphonates) while taking sorafenib * Patients with vascular diseases such as wet macular degeneration, vasculitis, or new peptic ulcer, may be enrolled but require close monitoring in accordance with established medical practice Exclusion Criteria: * Patients who are currently enrolled in, are eligible for, or have access to, any other sorafenib clinical trial * Patients who have participated in any other sorafenib trial * Patients who have had prior therapy with investigational agent(s) within the last four weeks prior to study entry * Life expectancy of less than two months * Patients with cardiac arrhythmias greater than grade 1 NCI CTCAE, Version 3.0 * Patients with active coronary artery disease or ischemia * Patients with Child-Pugh class C hepatic impairment * Patients with severe renal impairment or who require dialysis * Patients with active uncontrolled hypertension * Patients with recent or active bleeding diathesis
References
Publications (1)
- DERIVEDStadler WM, Figlin RA, McDermott DF, Dutcher JP, Knox JJ, Miller WH Jr, Hainsworth JD, Henderson CA, George JR, Hajdenberg J, Kindwall-Keller TL, Ernstoff MS, Drabkin HA, Curti BD, Chu L, Ryan CW, Hotte SJ, Xia C, Cupit L, Bukowski RM; ARCCS Study Investigators. Safety and efficacy results of the advanced renal cell carcinoma sorafenib expanded access program in North America. Cancer. 2010 Mar 1;116(5):1272-80. doi: 10.1002/cncr.24864. PMID 20082451