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

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ClinicalTrials.gov Identifier: NCT03066427
Recruitment Status : Recruiting
First Posted : February 28, 2017
Last Update Posted : February 7, 2019
Sponsor:
Collaborators:
Pfizer
Apices Soluciones S.L.
Information provided by (Responsible Party):
Spanish Oncology Genito-Urinary Group

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.


Condition or disease Intervention/treatment Phase
Clear Cell Renal Carcinoma Drug: Sunitinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : May 10, 2017
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : May 31, 2020


Arm Intervention/treatment
Experimental: Sunitinib
Sunitinib 50 mg/day, 4 weeks on/2weeks off
Drug: Sunitinib
Sunitinib 50 mg/d
Other Name: Sutent




Primary Outcome Measures :
  1. Objective response rate [ Time Frame: 12 months ]
    Percentage of patients with documented response according RECIST 1.1 criteria (complete response + partial response)


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 12 months ]
    Time from start of treatment to disease progression or death.

  2. Time to progression [ Time Frame: 12 months ]
    Time from start of treatment to disease progression or death due to the illness

  3. Duration of the response [ Time Frame: 12 months ]
    Time from first response to disease progression or death.

  4. Overall survival [ Time Frame: 18 months ]
    Time from start of treatment to death.

  5. Clinical benefit [ Time Frame: 12 months ]
    Percentage of patients with documented response or disease stabilization according RECIST 1.1 criteria

  6. Number of individual events (hematologic events and not hematologic events) [ Time Frame: 12 months ]
    Percentage of patients with each of the adverse event per grade



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03066427


Contacts
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Contact: Enrique Grande, MD +34918166804 egrande@oncologiahrc.com

Locations
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Spain
ICO Duran i Reynals Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
Contact: Xavier García del Muro, MD       garciadelmuro@iconcologia.net   
Principal Investigator: Xavier García del Muro, MD         
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Cristina Suárez, MD    +34 932746000 ext 4919    crsuarez@vhebron.net   
Principal Investigator: Cristina Suárez, MD         
Hospital Clínic i Provincial de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Oscar Reig, MD    08036 ext 2811    OREIG@clinic.cat   
Principal Investigator: Oscar Reig, MD         
Complejo Hospitalario Regional Reina Sofía Recruiting
Córdoba, Spain, 14004
Contact: María J Méndez, MD    +34 957012408    mjosemv@yahoo.es   
Principal Investigator: María J Méndez, MD         
Hospital Ramón Y Cajal Recruiting
Madrid, Spain, 28034
Contact: Teresa Alonso, MD    +34 913368263    talonso@oncologiahrc.com   
Principal Investigator: Teresa Alonso, MD         
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Contact: Daniel Castellano, MD    +34 913908339    cdanicas@hotmail.com   
Principal Investigator: Daniel Castellano, MD         
Centro Integral Oncologico Clara Campal Not yet recruiting
Madrid, Spain
Contact: Jesus Garcia-Donas         
Principal Investigator: Jesús García-Donas, MD         
MD Anderson Cancer Center Madrid Not yet recruiting
Madrid, Spain
Contact: Enrique Grande         
Principal Investigator: Enrique Grande, MD         
Hospital Central de Asturias Not yet recruiting
Oviedo, Spain
Contact: Emilio Esteban         
Principal Investigator: Emilio Esteban, MD         
Sponsors and Collaborators
Spanish Oncology Genito-Urinary Group
Pfizer
Apices Soluciones S.L.
Investigators
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Study Chair: Enrique Grande, MD MD Anderson Cancer Center Madrid
Principal Investigator: Cristina Suárez, MD Hospital Vall d'Hebron
Principal Investigator: Xavier García del Muro, MD Hestia Duran i Reynals
Principal Investigator: Oscar Reig, MD Hospital Clínic i Provincial de Barcelona
Principal Investigator: María J Méndez, MD Complejo Hospitalario Regional Reina Sofia
Principal Investigator: Daniel Castellano, MD Hospital Universitario 12 de Octubre
Principal Investigator: Teresa Alonso, MD Hospital Universitario Ramon y Cajal

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Responsible Party: Spanish Oncology Genito-Urinary Group
ClinicalTrials.gov Identifier: NCT03066427     History of Changes
Other Study ID Numbers: SOGUG-2016-A- IEC(REN)-10
2016-004011-12 ( EudraCT Number )
First Posted: February 28, 2017    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Spanish Oncology Genito-Urinary Group:
Clear Cell Renal Carcinoma
Sunitinib
Additional relevant MeSH terms:
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Protein Kinase Inhibitors
Carcinoma
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action