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

NCT03066427 | Completed Phase 2

• 2 other identifiers: SOGUG-2016-A- IEC(REN)-102016-004011-12
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 9

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.

Conditions

Clear Cell Renal Carcinoma

Keywords

Clear Cell Renal Carcinoma; Sunitinib

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  Percentage of patients with documented response according RECIST 1.1 criteria (complete response + partial response)

  12 months

Secondary Outcomes (6)

• Progression-free survival

  12 months

• Time to progression

  12 months

• Duration of the response

  12 months

• Overall survival

  18 months

• Clinical benefit

  12 months

Study Arms (1)

Sunitinib

EXPERIMENTAL

Sunitinib 50 mg/day, 4 weeks on/2weeks off

Drug: Sunitinib

Interventions

Sunitinib DRUG

Sunitinib 50 mg/d

Also known as: Sutent

Sunitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Eighteen years or older on the day of consent
• \. Documented histological or cytological diagnosis of renal cell cancer with a clear-cell component.
• \. Patient must have progressed to at least one immune check point inhibitor-based therapy (antiPD1, anti-PDL1 o antiCTLA4) for the first line
• \. Measurable disease per RECIST 1.1 as determined by the investigator
• \. The subjects should not present disease that may be subsidiary of surgical treatment, radiotherapy or combined treatment with curative intent.
• \. 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.
• \. Eastern Cooperative Oncology Group Performance Status (PS) 0-2
• \. Adequately controlled blood pressure (BP) with or without antihypertensive medication to maintain a BP \<150/90 mmHg before the start of study treatment.
• \. 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).
• \. Adequate liver function
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 × ULN.
• Total bilirubin ≤ 1.5 × upper limit of normal (ULN).

You may not qualify if:

• \. Previous treatments with sunitinib are not permitted for the advanced or localized disease.
• \. Radiation therapy or embolization within 2 weeks of first dose of sunitinib
• \. Prior high-dose chemotherapy requiring hematopoietic stem cell rescue.
• \. Current treatment on another clinical trial.
• \. Prior radiation therapy to \>25% of the bone marrow.
• \. Uncontrolled brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease.
• \. 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.
• \. Presence of an unhealed wound or active ulcer.
• \. Diarrhea grade III/IV in the screening period.
• \. 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.
• \. Clinically significant cardio-cerebrovascular disease within 6 months prior to initiation of treatment.
• \. Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2, atrial fibrillation of any grade that require treatment.
• \. Corrected QT interval (QTc) interval \>500 msec.
• \. Active hemoptysis within 6 weeks prior to initiation of study treatment.
• \. Evidence of active bleeding or hemorrhagic diathesis.

Sponsors & Collaborators

• Spanish Oncology Genito-Urinary Group: lead
• Pfizer: collaborator
• Apices Soluciones S.L.: collaborator

Study Sites (9)

ICO Duran i Reynals

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clínic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

Complejo Hospitalario Regional Reina Sofía

Córdoba, 14004, Spain

Location

Hospital Ramón Y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Centro Integral Oncologico Clara Campal

Madrid, Spain

Location

MD Anderson Cancer Center Madrid

Madrid, Spain

Location

Hospital Central de Asturias

Oviedo, Spain

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Enrique Grande, MD

  MD Anderson Cancer Center Madrid

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2017
• First Posted: February 28, 2017
• Study Start: May 10, 2017
• Primary Completion: September 22, 2020
• Study Completion: September 22, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (9)