A Phase II Study of Axitinib in Metastatic Non-clear Cell Renal Cell Carcinoma Patients Previously Treated With Temsirolimus
2 other identifiers
interventional
41
1 country
1
Brief Summary
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2013
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 20, 2013
CompletedFirst Posted
Study publicly available on registry
February 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedDecember 8, 2020
December 1, 2020
2.3 years
February 20, 2013
December 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival
PFS is a time from study enrollment to documented disease progression or death from any cause
Followed up during study drug administration till disease progression, unacceptable toxicitiy, or 1 year
Secondary Outcomes (4)
Response Rate
Every 8 weeks till disease progression, unacceptable toxicity or 1 year
Disease control rate (DCR)
Every 8 weeks till disease progression, unacceptable toxicity or 1 year
Overall survival
Every 8 weeks till disease progression, unacceptable toxicity or 1 year
Number of patients who experience adverse events related to drug and serious adverse events
Every 4 weeks till disease progression, unacceptable toxicity or 1 year
Study Arms (1)
Axitinib
EXPERIMENTALThis is a single arm study. Axitinib arm is the only arm who receive axitinib.
Interventions
Axitinib 5mg twice will be orally administered daily with one cycle of 4 weeks. The package of axitinib must be opened right before the administration due to its photosensitivity.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- Pfizercollaborator
Study Sites (1)
Seou National University Hospital
Seoul, 110744, South Korea
Related Publications (1)
Rini 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: 22056247BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Se-Hoon Lee, MD, PhD
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 20, 2013
First Posted
February 25, 2013
Study Start
February 1, 2013
Primary Completion
June 1, 2015
Study Completion
December 1, 2016
Last Updated
December 8, 2020
Record last verified: 2020-12