Clinical trial · Interventional
Sorafenib in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Sunitinib or Bevacizumab
A Phase II Study of Sorafenib in Patients With Metastatic Renal Cell Carcinoma (RCC) Refractory to SU11248 or Bevacizumab Therapy
NCT00866320CI-TRIAL-00015169completedPhase 2Results postedClinicalTrials.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)
RATIONALE: 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. PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with metastatic kidney cancer that has not responded to sunitinib or bevacizumab.
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 |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sorafenib tosylate | Drug | Sorafenib Tosylate | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sorafenib
- description
- Chemotherapy single agent systemic. Sorafenib given up to 600mg orally every 12 hours for up to 10 months (40 weeks).
- interventionNames
- Drug: sorafenib tosylate
Primary outcomes (1)
- measure
- Tumor Burden Reduction Rate (TBRR)
- timeFrame
- at 8 weeks (2cycles of treatment)
- description
- The primary endpoint of the study is defined as the percentage of patients who experience larger than or equal to 5% reduction in tumor burden as measured by RECIST-defined target lesions without progression of non-target lesions or the appearance of any new lesions, confirmed at least 4 weeks after first documentation. RECIST criteria will be used for the purpose of designating target lesions, calculating total tumor burden (the sum of the unidimensional measurement of target lesions) and defining disease progression.Additional RECIST-defined partial or complete responses will be recorded.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed renal cell carcinoma with a component of clear cell histology * Metastatic disease * Disease progression, as defined by RECIST criteria, after prior treatment with sunitinib malate or bevacizumab * Patients must have received ≥ 1 course (4 weeks) of sunitinib malate or ≥ 2 doses of bevacizumab AND have RECIST-defined objective progression during or within 4 months after completing treatment with sunitinib malate or bevacizumab * Measurable disease by RECIST criteria * CNS metastases allowed provided patient has undergone prior surgery and/or radiotherapy AND has no evidence of further CNS disease progression by CT scan or MRI ≥ 2 weeks after treatment of CNS metastases PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0-1 or Karnofsky PS 70-100% * WBC ≥ 3,000/μL * Absolute neutrophil count ≥ 1,500/μL * Platelet count ≥ 75,000/μL * Total bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST/ALT ≤ 2.5 times ULN * Creatinine ≤ 2.0 times ULN * Negative pregnancy test * No significant cardiovascular disease, including any of the following: * Congestive heart failure (New York Heart Association class III-IV heart disease) * Active angina pectoris requiring nitrate therapy * Uncontrolled dysrhythmias * Cardiovascular event within the past 6 months (e.g., transient ischemic attack/cerebrovascular accident, myocardial infarction, or vascular surgery) PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 2 weeks since prior systemic therapy, radiotherapy, or major surgery and recovered * No prior sorafenib tosylate * No other concurrent investigational agents * No other concurrent anticancer therapy * No concurrent prophylactic growth factors
References
Publications (0)
Data not yet available
No reference posted for this study.