Study to Evaluate Efficacy and Safety of Sunitinib in Renal Cell Carcinoma Progressed to 1L Immunotherapy Treatment.

NCT03066427

Last updated date
Study Location
ICO Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, 08908, Spain
Contact
+34918166804

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Clear Cell Renal Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Advanced Information
Descriptive Information
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 23, 2017)
23
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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, 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.

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.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Enrique Grande, MD+34918166804[email protected]
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Spanish Oncology Genito-Urinary Group
Study Sponsor  ICMJE Spanish Oncology Genito-Urinary Group
Collaborators  ICMJE
  • Pfizer
  • Apices Soluciones S.L.
Investigators  ICMJE
Study Chair:Enrique Grande, MDMD Anderson Cancer Center Madrid
Principal Investigator:Cristina Suárez, MDHospital Vall d'Hebron
Principal Investigator:Xavier García del Muro, MDHestia Duran i Reynals
Principal Investigator:Oscar Reig, MDHospital Clínic i Provincial de Barcelona
Principal Investigator:María J Méndez, MDComplejo Hospitalario Regional Reina Sofia
Principal Investigator:Daniel Castellano, MDHospital Universitario 12 de Octubre
Principal Investigator:Teresa Alonso, MDHospital Universitario Ramon y Cajal
PRS Account Spanish Oncology Genito-Urinary Group
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP