Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

PRednisone Plus EVerolimus in Patients With Metastatic Renal Cell Cancer After Failure of VEGFR -TKI (PREV)

12 januari 2018 bijgewerkt door: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Phase II Study of Oral PRednisone 5 mg Bid Plus EVerolimus in Patients With Metastatic Renal Cell Cancer After Failure of Vascular Endothelial Growth Factor Receptor-tyrosine Kinase Inhibitors

This is a multicenter prospective study that includes all patients with metastatic Renal Cell Cancer (RCC) pre- treated with VEGFR TKI in eight Italian cancer centers.

Everolimus is formulated as tablets of 5-10 mg strength, blister-packed under aluminium foil in units of 10 tablets. Prednisone will be dispensed to patients at the dose of 5 mg twice daily (BID). Everolimus at dose of 10 mg (one 10 mg tablet or two 5 mg tablets). Both drugs will be self-administered orally, continuously from Day 1 (Visit 2) until progression of disease, unacceptable toxicity, death or discontinuation for any other reason.

A treatment cycle consists of 28 days.

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Title Phase II study of oral PRednisone 5 mg bid plus EVerolimus in patients with metastatic renal cell cancer after failure of vascular endothelial growth factor receptor-tyrosine kinase inhibitor (PREV study).

Short Title/ Acronym PREV Protocol Code IRST189.04 Phase Phase 2 Study Design This is a multicenter prospective study that includes all patients with metastatic RCC pre- treated with VEGFR TKI in eight Italian cancer centers.

Study Duration 2 years of recruitment and 1 year of follow-up Study Center(s) multi-center: 8 centers involved

Objectives Primary objective:

To evaluate the safety and tolerability of prednisone 5 mg bid and everolimus 10 mg/day in RCC.

Secondary objectives:

To evaluate the activity and the clinical outcome of these patients.

Exploratory objectives:

To evaluate the influence of prednisone on trough concentration of everolimus and correlation with the incidence of side effects, in particular stomatitis and non-infectious pneumonitis.

Infiammation markers such as pentraxin 3 (PTX3), IL-6, TGF-β and neutrophil-lymphocyte ratio will be correlated with clinical outcome (ORR, PFS, OS).

Number of Subjects 42 subjects Diagnosis and Main Inclusion Criteria Patients with mRCC who failed at least one VEGFR TKI.

Main Inclusion Criteria:

  • Patients with renal cell carcinoma who failed at least one VEGFR TKI
  • Patients with adequate bone marrow function
  • Patients with adequate liver function
  • Patients with adequate renal function Diagnosis and Main Inclusion Criteria (continued) Main exclusion criteria:
  • CNS disease OR patients with presence or history of central nervous system (CNS) lymphoma
  • Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent (except corticosteroids with a daily dosage equivalent to prednisone ≤ 20 mg for adrenal insufficiency). However, patients receiving corticosteroids must be on a stable dose for ≥ 4 weeks prior to the first dose of everolimus. Topical or inhaled corticosteroids are permitted.
  • Patients with a known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or to its excipients
  • Patients with uncontrolled hyperlipidemia (≥ Grade 3 hyperlipidemia despite optimal supportive medical therapy)
  • Patients with an active, bleeding diathesis
  • Previous organ transplantation
  • Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study Study Product, Dose, Route, Regimen and duration of administration Everolimus is formulated as tablets of 5-10 mg strength, blister-packed under aluminium foil in units of 10 tablets. Prednisone will be dispensed to patients at the dose of 5 mg twice daily (BID). Everolimus at dose of 10 mg (one 10 mg tablet or two 5 mg tablets). Both drugs will be self-administered orally, continuously from Day 1 (Visit 2) until progression of disease, unacceptable toxicity, death or discontinuation for any other reason.

A treatment cycle consists of 28 days. Reference therapy Not applicable Statistical Methodology This is a multicenter prospective study that includes all patients with metastatic RCC pre- treated with VEGFR TKI in eight Italian cancer centers.

The study will be analyzed on an intent-to-treat basis. Secondary parameters will be analyzed exploratively for the intent-to-treat population.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

8

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Italië
      • Rimini, Italië, 47923
        • Oncologia Medica, PO Rimini-Cattolica, AUSL della Romagna
    • FC
      • Meldola, FC, Italië, 47014
        • U.O Oncologia Medica, IRST IRCCS
    • RA
      • Faenza, RA, Italië, 48121
        • Oncologia Medica, PO Faenza, AUSL della Romagna
      • Ravenna, RA, Italië, 48121
        • Oncologia Medica, PO RAVENNA, AUSL della Romagna

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. Age ≥ 18 years old
  2. Patients with histopathologically confirmed diagnosis of renal cell carcinoma
  3. Patients with renal cell carcinoma who failed at least one VEGFR TKI
  4. Patients with adequate bone marrow function defined as ANC ≥ 1.5 x 109/L, Platelets ≥ 80 x 109/L, Hb >9 g/dL
  5. Patients with adequate liver function defined as serum bilirubin ≤ 1.5 x ULN, ALT and AST ≤ 2.5x ULN. Patients with known liver metastases who have an AST and ALT ≤ 5x ULN
  6. Patients with adequate renal function defined as serum creatinine ≤ 1.5 x ULN
  7. Patients who give a written informed consent obtained according to local guidelines

Exclusion Criteria:

  1. CNS disease OR patients with presence or history of central nervous system (CNS) lymphoma
  2. Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent (except corticosteroids with a daily dosage equivalent to prednisone ≤ 20 mg for adrenal insufficiency). However, patients receiving corticosteroids must be on a stable dose for ≥ 4 weeks prior to the first dose of everolimus. Topical or inhaled corticosteroids are permitted.
  3. Patients with a known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or to its excipients
  4. Patients with uncontrolled hyperlipidemia (≥ Grade 3 hyperlipidemia despite optimal supportive medical therapy)
  5. Patients with an active, bleeding diathesis
  6. Previous organ transplantation

  7. Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:

    • unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease
    • severely impaired lung function (spirometry and DLCO that is 50% of the normal predicted value and/or Oxygen saturation that is 88% or less at rest, in room air)
    • uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN
    • any active (acute or chronic) or uncontrolled infections/disorders
    • non malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with this study therapy
    • liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C).
    • Note: a detailed assessment of Hepatitis B/C medical history and risk factors must be done at screening for all patients. HBV DNA and HCV RNA PCR testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection.
  8. A known history of HIV seropositivity
  9. Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not willing to use effective birth control methods. If barrier contraceptives are used, they must be continued throughout the treatment by both sexes.
  10. Patients unwilling to or unable to comply with the protocol

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Prednisone + Everolimus
Geneesmiddel: Prednisone + Everolimus

Prednisone + Everolimus: Everolimus is formulated as tablets of 5-10 mg strength, blister-packed under aluminium foil in units of 10 tablets. Prednisone will be dispensed to patients at the dose of 5 mg twice daily (BID). Everolimus at dose of 10 mg (one 10 mg tablet or two 5 mg tablets). Both drugs will be self-administered orally, continuously from Day 1 (Visit 2) until progression of disease, unacceptable toxicity, death or discontinuation for any other reason.

A treatment cycle consists of 28 days.

Andere namen:
  • prednison
  • everolimus

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
safety and tolerability evaluation (incidence of grade ≥ 2 stomatitis and non-infectious pneumonitis)
Tijdsspanne: up to 36 months
to evaluate the incidence of grade ≥ 2 stomatitis and non-infectious pneumonitis in RCC patients treated with prednisone 5 mg bid and everolimus 10 mg/day.
up to 36 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall response rate (ORR)
Tijdsspanne: up to 36 months
the sum of partial responses plus complete responses
up to 36 months
Progression free survival (PFS)
Tijdsspanne: up to 36 months
time from the date of starting of the treatment to the date of the first observation of documented disease progression or death due to any cause. Patients without tumor progression at the time of analysis will be censored at their last date of tumor evaluation.
up to 36 months
Overall survival (OS)
Tijdsspanne: up to 36 months
time from the date of starting of the treatment to the date of the death due to any cause. Patients living at the time of analysis will be censored at their last date of tumor evaluation.
up to 36 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

22 september 2015

Primaire voltooiing (Werkelijk)

5 mei 2017

Studie voltooiing (Werkelijk)

1 september 2017

Studieregistratiedata

Eerst ingediend

19 juni 2015

Eerst ingediend dat voldeed aan de QC-criteria

23 juni 2015

Eerst geplaatst (Schatting)

24 juni 2015

Updates van studierecords

Laatste update geplaatst (Werkelijk)

16 januari 2018

Laatste update ingediend die voldeed aan QC-criteria

12 januari 2018

Laatst geverifieerd

1 januari 2018

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • IRST189.04

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Gemetastaseerde nierkanker

Klinische onderzoeken op Prednisone + Everolimus

Zoek naar vergelijkbare onderzoeken

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

CROs by country

CROs in Zimbabwe

Voorwaarden

Zeldzame ziekten

Geneesmiddelinterventies

Voedingssupplementen

Sponsor / medewerkers

Locaties

Abonneren