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The Efficacy and Safety of Apatinib Combined With Etoposide in Heavily Pretreated Advanced Non-small Cell Lung Cancer

10. april 2016 opdateret af: Xueqin Yang, Third Military Medical University

The Efficacy and Safety of Apatinib Combined With Etoposide in Advanced Non-small Cell Lung Cancer Patients Failed to Previous at Least 2rd Line Treatments

The development of anti-angiogenesis drugs has led to renewed enthusiasm in lung cancer treatments. Apatinib is a tyrosine kinase inhibitor which selectively inhibits the vascular endothelial growth factor receptor-2 (VEGFR-2). Etoposide is an oral preparation for lung cancer which is recommended by NCCN guideline. The investigators wondered whether these two drugs have synergistic effects when treating advanced non-small cell lung cancer patients who failed to previous at least 2nd line treatments. Thus, the aim of this trial is to investigate the efficacy and safety of apatinib combined with etoposide in heavily pretreated advanced non-small cell lung cancer.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

25

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Chongqing
      • Chongqing, Chongqing, Kina, 400042
        • Rekruttering
        • Daping Hospital, Third Military Medical University
        • Kontakt:
        • Ledende efterforsker:
          • Xueqin Yang, PH.D.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Obtain of informed consent.
  • Histologically or cytologically confirmed non-small cell lung cancer.
  • World Health Organization (WHO) performance status (PS) of 0 to 2.
  • Measurable lesions as defined by RECIST criteria.
  • Second-line or more treatments.
  • Wild type of epidermal-growth-factor receptor (EGFR).
  • Life expectancy ≥12 weeks.

  • Organ functions normal, as defined below, within two weeks of randomization:

    • Hb≥90g/L Absolute neutrophils count(ANC)≥1.5×109/L Platelets≥80×109/L Serum bilirubin≤2×ULN; Aspartate transaminase(AST) and alanine transaminase (ALT)≤2.5×ULN(≤5×ULN if liver metastases) Creatinine clearance≥45ml/min or Cr≤1.25×ULN.

  • Females of child-bearing potential must have negative serum pregnancy test.
  • Sexually active males and females (of childbearing potential) willing to practice contraception during the study.

Exclusion Criteria:

  • Small cell lung cancer.
  • Newly diagnosed Central Nervous System (CNS) metastases that have not yet been definitively treated with surgery and/or radiation.
  • Uncontrolled hypertension.
  • Myocardial ischemia or infarction more than stage II, cardiac insufficiency.
  • Abnormal coagulation (INR>1.5 or PT>ULN+4, or APTT>1.5 ULN), bleeding tendency or receiving coagulation therapy.
  • Difficulties in taking pills (inability to swallow tablets,GI tract resection, chronic bacillary diarrhea and intestinal obstruction).
  • Hemoptysis, more than 2.5ml daily.
  • Thrombosis in 12 months, including pulmonary thrombosis, stoke, or deep venous thrombosis.
  • Unhealed bone fracture or wound for long time.
  • Received big surgery, had bone fracture or ulcer in 4 weeks.
  • Urine protein≥++, or urine protein in 24 hours≥1.0g.
  • Pregnant or lactating woman.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Apatinib+Etoposide
Apatinib combined with Etoposide
Medicin: Apatinib
Apatinib, 250mg daily, po, continue until disease progression
Medicin: Etoposide
Etoposide, 50mg daily, po, day 1 to day 20, repeat Q 4 weeks until disease progression
Andre navne:
  • VP-16

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression free survival
Tidsramme: evaluated in 24 months since the treatment began
the first day of treatment to the date that disease progression is reported
evaluated in 24 months since the treatment began

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective Response Rate
Tidsramme: tumor assessment every 6-8 weeks since the treatment began，up to 24 months
the ratio between the number of responders and number of patients assessable for tumor response
tumor assessment every 6-8 weeks since the treatment began，up to 24 months
Overall survival
Tidsramme: the first day of treatment to death or last survival confirm date,up to 24 months
the first day of treatment to death or last survival confirm date,up to 24 months
Side effects
Tidsramme: evaluated in the 24th month since the treatment began according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
evaluated in the 24th month since the treatment began according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Third Military Medical University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2016

Primær færdiggørelse (Forventet)

1. december 2019

Studieafslutning (Forventet)

1. december 2020

Datoer for studieregistrering

Først indsendt

5. april 2016

Først indsendt, der opfyldte QC-kriterier

8. april 2016

Først opslået (Skøn)

11. april 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

12. april 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. april 2016

Sidst verificeret

1. april 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ACEL

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Ikke-småcellet lungekræft

Kliniske forsøg med Apatinib

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Kenya

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner