Clinical trial · Interventional
A Phase II Study of Axitinib in Metastatic Non-clear Cell Renal Cell Carcinoma Patients Previously Treated With Temsirolimus
NCT01798446CI-TRIAL-00048684completedPhase 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)
* 1\. There is no standard treatment option for non-clear cell renal cell carcinoma (RCC). * 2\. Patients with non-clear cell RCC is strongly assumed to have benefit from anti-VEGF treatment. * 3\. There is no trial of axitinib for non-clear cell RCC. * 4\. Axitinib is expected to show more potent efficacy over sorafenib or sunitinib in renal cell carcinoma.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nonclear Cell | — | UNRESOLVED | — |
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Temsirolimus Resistance | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Axitinib | Drug | Axitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Axitinib
- description
- This is a single arm study. Axitinib arm is the only arm who receive axitinib.
- interventionNames
- Drug: Axitinib
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- Followed up during study drug administration till disease progression, unacceptable toxicitiy, or 1 year
- description
- PFS is a time from study enrollment to documented disease progression or death from any cause
Secondary outcomes (4)
- measure
- Response Rate
- timeFrame
- Every 8 weeks till disease progression, unacceptable toxicity or 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmation of RCC without a clear cell histologic component, e.g., papillary type, chromophobe type, medullary type or unclassified) * Patients with stage IV or recurrent disease not amenable to surgery, radiotherapy, or combined modality therapy with curative intent * Previous treatment with temsirolimus * Measurable disease according to RECIST criteria * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Age 18 years or older * Adequate cardiac function * Adequate bone marrow, hepatic, and renal function * Hematology: Neutrophil same or more than 1.5 x 10\^9/L Platelet same or more than 75 x 10\^9/L Hemoglobin same or more than 9 g/dL -Liver function tests: Total bilirubin same or less than 1.5 x upper limit normal (xULN) aspartate aminotransferase(AST), alanine aminotransferase (ALT) same or less than 2.5 xULN Alkaline phosphatase same or less than 2.5 xULN -Renal function tests: Creatinine clearance same or more than 30 mL/min * Life expectancy more than 3 months * Signed and dated informed consent of document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment Exclusion Criteria: * Clear cell type RCC * Composed of mostly sarcomatoid carcinoma * Collecting duct type RCC * Diagnosis of any serious secondary malignancy within the last 2 years, except for adequately treated basal cell or squamous cell carcinoma of skin, or in situ carcinoma of cervix uteri * Hypertension that cannot be controlled by medications (blood pressure 150/90 mmHg despite optimal medical therapy) * Pregnancy or breast feeding * Other severe acute or chronic medical or psychiatric condition * Prior treatment on sunitinib, sorafenib, pazopanib or bevacizumab * Uncontrolled central nerve system (CNS) metastasis (brain and/or leptomeningeal metastasis) * Patients who require concomitant treatment with potent cytochrome P 3A4 ( CYP3A4) inducers and inhibitors
References
Publications (1)
- BACKGROUNDRini BI, Escudier B, Tomczak P, Kaprin A, Szczylik C, Hutson TE, Michaelson MD, Gorbunova VA, Gore ME, Rusakov IG, Negrier S, Ou YC, Castellano D, Lim HY, Uemura H, Tarazi J, Cella D, Chen C, Rosbrook B, Kim S, Motzer RJ. Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomised phase 3 trial. Lancet. 2011 Dec 3;378(9807):1931-9. doi: 10.1016/S0140-6736(11)61613-9. Epub 2011 Nov 4. PMID 22056247