EUCTR2016-004011-12-ES
Active, not recruiting
Phase 1
Phase II study to evaluate efficacy and safety of sunitinib therapy in patients with metastatic renal clear cell carcinoma who have progressed to first-line immunotherapy treatment (INMUNOSUN Study) - INMUNOS
SOGUG (Spanish Oncology Genitourinary Group)0 sitesJanuary 13, 2017
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- metastatic renal clear cell carcinoma
- Sponsor
- SOGUG (Spanish Oncology Genitourinary Group)
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Eighteen years or older on the day of consent
- •2\. Documented histological or cytological diagnosis of renal cell cancer with a clear\-cell component.
- •3\. Patient must have progressed to at least one immune check point inhibitor\-based therapy (antiPD1, antiPDL1 o antiCTLA4\) for the first line
- •4\. Measurable disease per RECIST 1\.1 as determined by the investigator
- •5\. The subjects should not present disease that may be subsidiary of surgical treatment, radiotherapy or combined treatment with curative intent.
- •6\. Recovery of toxicities related to any prior treatments to \= Grade 1 CTCAE v.4\.03, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy
- •7\. ECOG Performance Status (PS) 0\-2
- •8\. Adequately controlled blood pressure (BP) with or without antihypertensive medication to maintain a BP \<150/90 mmHg before the start of study treatment.
- •9\. Adequate marrow function
- •\- Absolute neutrophil count (ANC) \= 1500/mm3 (\= 1\.5 GI/L).
Exclusion Criteria
- •1\. Previous treatments with sunitinib are not permitted for the advanced or localized disease.
- •2\. Major surgery within 3 weeks of patient inclusion
- •3\. Radiation therapy or embolization within 2 weeks of first dose of sunitinib
- •4\. Previous treatment with immunosuppressive drugs such as cyclosporine, tacrolimus, azathioprine, or long\-term oral glucocorticoids taken prior to (3 months) patient inclusion
- •5\. Prior high\-dose chemotherapy requiring hematopoietic stem cell rescue.
- •6\. Current treatment on another clinical trial.
- •7\. Treatment with known potent CYP3A4 inhibitors or inducers or that prolong the QT interval, within 7 days prior to the inclusion.
- •8\. Prior radiation therapy to \>25% of the bone marrow.
- •9\. Uncontrolled brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease.
- •10\. Any gastrointestinal malabsorption disorder or any other condition that, in the opinion of the investigator, may affect the absorption of sunitinib or increase the risk of bleeding or perforation.
Outcomes
Primary Outcomes
Not specified
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