Clinical trial · Interventional
Long-term Extension From RCC Phase II (11515)
Extension Study for BAY43-9006 in Japanese Patients With Renal Cell Carcinoma
NCT00586495CI-TRIAL-00012974completedPhase 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)
Extension to study 11515 (NCT00661375) which was a multicenter study of sorafenib in patients with renal cell carcinoma (RCC).
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
- Sorafenib (Nexavar, BAY43-9006)
- description
- Sorafenib 200 mg tablets (400 mg \[2 x 200 mg tablets\] twice daily \[bid\] or 400 mg once daily \[od\] or 400 mg every other day \[qod\]) administered orally
- interventionNames
- Drug: Sorafenib (Nexavar, BAY43-9006)
Primary outcomes (1)
- measure
- Progression Free Survival (PFS)
- timeFrame
- From start of treatment of the first subject until 45 months later, assessed every 8 weeks
- description
- Time from initiation of treatment to disease progression (radiological or clinical, whichever earlier) or death (if death occurs before progression).
Secondary outcomes (5)
- measure
- Best Tumor Response
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Patients are classified into two groups as below at transition date from Study 11515 to this study. Population I: Patients who are willing to continue the study drug, for whom the investigator consider continuation of the study drug is appropriate, and who do not meet the criteria of removal from the study in Study 11515 at the end of Study 11515. Population II: Patients who have been monitored only for survival status at the end of Study 11515. Population 1 1. Patients who are willing to continue the study drug, 2. Patients for whom the investigator consider continuation of the study drug is appropriate 3. Patients who do not meet the criteria of removal from the study in Study 11515 at the end of Study 11515. 4. Patients who give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, without prejudice. Population 2 1\. Patients who give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, without prejudice. Exclusion Criteria: 1. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results 2. Any condition that could jeopardize the safety of the patient or that affect his/her compliance in the study 3. Pregnant or breast-feeding patients. Both men and women enrolled in this trial must use adequate birth control.
References
Publications (1)
- RESULTNaito S, Tsukamoto T, Murai M, Fukino K, Akaza H. Overall survival and good tolerability of long-term use of sorafenib after cytokine treatment: final results of a phase II trial of sorafenib in Japanese patients with metastatic renal cell carcinoma. BJU Int. 2011 Dec;108(11):1813-9. doi: 10.1111/j.1464-410X.2011.10281.x. Epub 2011 Apr 11. PMID 21481133