A Phase II Study of Axitinib in Metastatic Non-clear Cell Renal Cell Carcinoma Patients Previously Treated With Temsirolimus
|ClinicalTrials.gov Identifier: NCT01798446|
Recruitment Status : Completed
First Posted : February 25, 2013
Last Update Posted : December 8, 2020
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma Nonclear Cell Temsirolimus Resistance||Drug: Axitinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Axitinib in Metastatic Non-clear Cell Renal Cell Carcinoma Patients Previously Treated With Temsirolimus|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||December 2016|
This is a single arm study. Axitinib arm is the only arm who receive axitinib.
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.
- Progression Free Survival [ Time Frame: Followed up during study drug administration till disease progression, unacceptable toxicitiy, or 1 year ]PFS is a time from study enrollment to documented disease progression or death from any cause
- Response Rate [ Time Frame: Every 8 weeks till disease progression, unacceptable toxicity or 1 year ]Tumor response according to Response Evaluation Criteria for Solid Tumor (RECIST) criteria version 1.1
- Disease control rate (DCR) [ Time Frame: Every 8 weeks till disease progression, unacceptable toxicity or 1 year ]Disease control (complete remission + partial remission + stable disease) rate according to RECIST criteria version 1.1
- Overall survival [ Time Frame: Every 8 weeks till disease progression, unacceptable toxicity or 1 year ]Duration from study enrollment to death from any cause
- Number of patients who experience adverse events related to drug and serious adverse events [ Time Frame: Every 4 weeks till disease progression, unacceptable toxicity or 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01798446
|Korea, Republic of|
|Seou National University Hospital|
|Seoul, Korea, Republic of, 110744|
|Principal Investigator:||Se-Hoon Lee, MD, PhD||Seoul National University Hospital|