A Phase 2 interventional study of Sunitinib in Clear Cell Renal Carcinoma, sponsored by Spanish Oncology Genito-Urinary Group. Completed at 9 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-13.
Sponsored by Spanish Oncology Genito-Urinary Group · Phase 2, Interventional, and Treatment
The therapeutic scenario of metastatic renal cancer is undergoing a new revolution with the appearance of a novel therapeutic strategy after the antiangiogenic treatments, that is the immunotherapy, in addition to the approval of new active drugs in the following lines of treatment.
There are currently two phase III trials in the first line of treatment in metastatic renal cancer that include different combinations of treatment based on immunotherapy. If results of these studies were positive, the therapeutic algorithm would be modified so that the remaining drugs would have to be repositioned within the therapeutic decision scheme.
Sunitinib has previously demonstrated its benefit in patients who had failed to prior treatment with cytokines, so it is likely to continue to be effective in patients who have become resistant to treatment with new drugs based on immune checkpoint blockade.
This phase II study is developed to evaluate the activity of sunitinib after treatment with immunotherapy-based regimens that are currently being developed within phase III clinical trials.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 23 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Spanish Oncology Genito-Urinary Group is the lead sponsor of 30 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adequate marrow function
Adequate liver function
Exclusion Criteria:
Other clinically significant alterations:
Sunitinib 50 mg/day, 4 weeks on/2weeks off
Drug: Sunitinib
Sunitinib 50 mg/d
Also known as: Sutent
Objective response rate
Percentage of patients with documented response according RECIST 1.1 criteria (complete response + partial response)
Time frame: 12 months
Progression-free survival
Time from start of treatment to disease progression or death.
Time frame: 12 months
Time to progression
Time from start of treatment to disease progression or death due to the illness
Time frame: 12 months
Duration of the response
Time from first response to disease progression or death.
Time frame: 12 months
Overall survival
Time from start of treatment to death.
Time frame: 18 months
Clinical benefit
Percentage of patients with documented response or disease stabilization according RECIST 1.1 criteria
Time frame: 12 months
Number of individual events (hematologic events and not hematologic events)
Percentage of patients with each of the adverse event per grade
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Spanish Oncology Genito-Urinary Group