Study to Evaluate Efficacy and Safety of Sunitinib in Renal Cell Carcinoma Progressed to 1L Immunotherapy Treatment.
NCT03066427
ABOUT THIS STUDY
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- 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, anti-PDL1 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 adverse event(s) are clinically nonsignificant and/or stable on supportive therapy.
- 7. Eastern Cooperative Oncology Group 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).
- Platelets ≥ 100,000/mm3 (≥ 100 GI/L).
- Hemoglobin ≥ 9 g/dL (≥ 5,6 mmol/L).
- 10. Adequate liver function
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 × ULN.
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN).
- 11. Adequate kidney function: calculated creatinine clearance ≥ 30 mL/min (≥ 0.5 mL/sec) using the Cockroft-Gault equation
- 12. Proteinuria <2+ on urine test strip
- 13. Prothrombin Time (PT) or International Standard Ratio (INR) ≤ 1.2 x ULN.
- 14. Life expectancy >3 months.
- 15. Patient able to ingest study drug and meet study follow-up requirements.
- 16. Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception
- 17. Female subjects of childbearing potential must not be pregnant at screening.
- 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.
- 11. Presence of an unhealed wound or active ulcer.
- 12. Diarrhea grade III/IV in the screening period.
- 13. Diagnosis of any second malignancy within the last 3 years, except for adequately
treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
- 14. Clinically significant cardio-cerebrovascular disease within 6 months prior to
initiation of treatment.
- 15. Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2, atrial fibrillation of any
grade that require treatment.
- 16. Corrected QT interval (QTc) interval >500 msec.
- 17. Active hemoptysis within 6 weeks prior to initiation of study treatment.
- 18. Evidence of active bleeding or hemorrhagic diathesis.
- 19. Presence of endobronchial lesions and / or lesions that infiltrate large vessels.
- 20. Current treatment with therapeutic doses of Coumadin (low dose Coumadin up to 2 mg
PO daily for deep vein thrombosis prophylaxis is allowed).
- 21. Other clinically significant alterations:
- Known human immunodeficiency virus (HIV) infection.
- Presence of an uncontrolled active infection.
- Presence of uncontrolled or symptomatic hypothyroidism.
- Moderate-severe liver disease (Child Pugh B-C).
- Requirement for hemodialysis or peritoneal dialysis.
- History of solid organ transplantation.
- 22. Pregnancy or breastfeeding.
- 23. Any disease that, in the opinion of the investigator, interferes with the
patient's ability to participate in the clinical trial.
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Descriptive Information | ||||||||||||||||||||||
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Brief Title ICMJE | Study to Evaluate Efficacy and Safety of Sunitinib in Renal Cell Carcinoma Progressed to 1L Immunotherapy Treatment. | |||||||||||||||||||||
Official Title ICMJE | 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) | |||||||||||||||||||||
Brief Summary | 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. | |||||||||||||||||||||
Detailed Description | Not Provided | |||||||||||||||||||||
Study Type ICMJE | Interventional | |||||||||||||||||||||
Study Phase ICMJE | Phase 2 | |||||||||||||||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||||||||||||||||||||
Condition ICMJE | Clear Cell Renal Carcinoma | |||||||||||||||||||||
Intervention ICMJE | Drug: Sunitinib
Sunitinib 50 mg/d Other Name: Sutent | |||||||||||||||||||||
Study Arms ICMJE | Experimental: Sunitinib
Sunitinib 50 mg/day, 4 weeks on/2weeks off Intervention: Drug: Sunitinib | |||||||||||||||||||||
Publications * | Not Provided | |||||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||||||||||||||||||||
Recruitment Information | ||||||||||||||||||||||
Recruitment Status ICMJE | Completed | |||||||||||||||||||||
Actual Enrollment ICMJE | 23 | |||||||||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | |||||||||||||||||||||
Actual Study Completion Date ICMJE | September 22, 2020 | |||||||||||||||||||||
Actual Primary Completion Date | September 22, 2020 (Final data collection date for primary outcome measure) | |||||||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||||||||||||||
Listed Location Countries ICMJE | Spain | |||||||||||||||||||||
Removed Location Countries | ||||||||||||||||||||||
Administrative Information | ||||||||||||||||||||||
NCT Number ICMJE | NCT03066427 | |||||||||||||||||||||
Other Study ID Numbers ICMJE | SOGUG-2016-A- IEC(REN)-10 2016-004011-12 ( EudraCT Number ) | |||||||||||||||||||||
Has Data Monitoring Committee | No | |||||||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Spanish Oncology Genito-Urinary Group | |||||||||||||||||||||
Study Sponsor ICMJE | Spanish Oncology Genito-Urinary Group | |||||||||||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Spanish Oncology Genito-Urinary Group | |||||||||||||||||||||
Verification Date | October 2020 | |||||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |