Clinical trial · Interventional
Research Study for Patients With Metastatic Renal Cell Carcinoma
A Phase II Study of BAY 43-9006 Prior to and Following Nephrectomy in Patients With Metastatic Renal Cell Carcinoma.
NCT00110344CI-TRIAL-00012380terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 study has been designed to study patients diagnosed with advanced renal cell cancer with the primary tumor in place.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nexavar (Sorafenib, BAY43-9006) | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1
- interventionNames
- Drug: Nexavar (Sorafenib, BAY43-9006)
- type
- PLACEBO_COMPARATOR
- label
- Arm 2
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Best Overall Response Rate (complete and partial response rate)
- timeFrame
- During study treatment or within 30 days after termination of active therapy
Secondary outcomes (4)
- measure
- Progression-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Life expectancy of at least 12 weeks * Clinical, radiographic, or pathologic diagnosis of metastatic renal cell carcinoma (RCC). All renal cell histologies are allowed- Acceptable surgical risk in the judgment of the study investigator and consulting urological surgeon * At least one uni-dimensional measurable lesion outside the planned nephrectomy specimen * Patients who have an ECOG performance status of 0 or 1 Exclusion Criteria: * History of bleeding diathesis or unexpected surgical bleeding- Patients currently receiving treatment with or having a requirement for therapeutic anticoagulation * Prior therapy for RCC. Palliative radiation therapy for painful or unstable bone metastases is permitted provided that there is measurable metastatic disease outside the radiation field * Known history of HIV infection- Symptomatic metastatic brain or meningeal tumors, unless the patient is \> 6 months from definitive therapy, has a CT or MRI scan within 6 weeks of study entry negative for brain metastases and is clinically stable with respect to the tumor at the time of study entry
References
Publications (0)
Data not yet available
No reference posted for this study.