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A Study of ABT-263 as Single Agent in Women With Platinum Resistant/Refractory Recurrent Ovarian Cancer (MONAVI-1)

15. marts 2019 opdateret af: Centre Francois Baclesse
ABT-263 as single agent in women with platinum resistant/refractory recurrent ovarian cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

47

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Frankrig
      • Besançon, Frankrig
        • CHU Besançon - Hôpital Jean Minjoz
      • Bordeaux, Frankrig
        • Institut Bergonie
      • Caen, Frankrig
        • Centre Francois Baclesse
      • Lille, Frankrig
        • Centre Oscar Lambret
      • Lyon, Frankrig
        • CHU
      • Lyon, Frankrig
        • Centre Leon Berard
      • Montpellier, Frankrig
        • ICM Val d'Aurelle
      • Nancy, Frankrig
        • ICL Institut de Cancérologie de Lorraine
      • Nantes, Frankrig
        • Centre Catherine de Sienne
      • Nantes, Frankrig
        • ICO Centre René Gauducheau
      • Nantes, Frankrig
        • ICO Paul Papin
      • Nice, Frankrig
        • Centre Antoine Lacassagne
      • Paris, Frankrig
        • Hôpital Européen Georges Pompidou
      • Paris, Frankrig
        • Hopital Tenon
      • Toulouse, Frankrig
        • Institut Claudius Regaud
      • Villejuif, Frankrig
        • Gustave Roussy

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

Kvinde

Beskrivelse

Inclusion Criteria:

  • - Woman older than 18 years
  • Subjects with Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Histologically and/or cytologically documented high grade serous epithelial cancer of ovarian, fallopian tube or peritoneum
  • Platinum resistant ovarian cancer defined as relapsing within 6 months after a platinum based chemotherapy OR platinum refractory ovarian cancer defined as progressing during a platinum based chemotherapy (excepted refractory patients in first line)
  • Subjects having received at least 2 prior lines of treatments including platinum regimen
  • Subjects who are willing and able to comply with the protocol and study procedures including willingness to undergo tumor biopsy before therapy at screening
  • There is no limitation to prior number of therapies
  • Patients must have documented disease progression
  • Subjects who have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

  • Adequate bone marrow, renal and hepatic function per local laboratory reference range as follows:• Absolute Neutrophil Count ≥ 1500/ mm3

    • Platelets ≥ 150,000 / mm3
    • Hemoglobin ≥ 9.0 g/dL
    • Renal function: Serum creatinine ≤1.2mg/dL or calculated creatinine clearance ≥ 60mL/min
    • AST/ALT ≤ 3.0× the upper limit of normal (ULN); [Subjects with liver metastasis may have AST, ALP, and ALT less then or equal to 5.0 X ULN]
    • Bilirubin ≤ 1.25×ULN
    • Coagulation: aPTT and PT not to exceed 1.2 × ULN
  • LVEF > 50% by echocardiograms or MUGA
  • Patients must give written informed consent

Exclusion Criteria:

  • Patient's refusal or impossibility to perform biopsy on relapsing disease
  • Bowel occlusive syndrome or other gastro-intestinal disorder that does not allow oral medication such as malabsorption
  • Patients with platinum refractory disease in first line
  • Received radio-immunotherapy within 6 months of 1st dose of study drug
  • Received steroid therapy for anti-neoplastic intent within 7 days of the 1st dose of study drug (Inhaled steroids for asthma, topical steroids, replacement/stress corticosteroids, or corticosteroids taken as premedication are allowed)
  • Consumption of grapefruit or grapefruit products within 3 days prior to the first dose of study drug
  • Patient receiving treatments strong CYP3A4 inhibitors or inducers (Appendix A)
  • Positive for HIV and VHC
  • Predisposing condition/currently exhibiting signs of bleeding
  • Currently receiving anticoagulation therapy, exception of low-dose anticoagulation medications for prophylaxis
  • Received aspirin within 7 days of start dose of study drug
  • Active peptic ulcer disease / other potentially hemorrhagic esophagitis/gastritis
  • Active immune thrombocytopenic purpura, autoimmune hemolytic anemia or history of being refractory to platelet transfusions (within 1 year of 1st dose of study drug)
  • Uncontrolled cardiac, renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease, active systemic fungal infection; diagnosis of fever and neutropenia within 1 week of study drug administration
  • A evidence of current/active malignancies other than ovarian cancer
  • Pregnant or lactating women

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
Eksperimentel: ABT-263
oral Navitoclax (ABT-263) daily
Medicin: ABT-263

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
The primary endpoint is the progression-free survival (PFS) in the whole cohort of patients with a recurrent platinum-resistant ovarian cancer.
Tidsramme: the time to progression (or death from any cause) from date of randomization until date of first documented progression or date of death from any cause,whichever came first, assessed up to 12 months. Evaluation at interim and final analyses.
the time to progression (or death from any cause) from date of randomization until date of first documented progression or date of death from any cause,whichever came first, assessed up to 12 months. Evaluation at interim and final analyses.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Bim expression level
Tidsramme: biopsy sample before initiation of treatment by ABT-263 and assessment within 6 months after end of inclusions
Bim expression level expressed by immunohistochemistry on biopsy of relapsing tumor at inclusion
biopsy sample before initiation of treatment by ABT-263 and assessment within 6 months after end of inclusions
Response rate
Tidsramme: evaluated every 6 weeks during treatment to progression or death for any cause.(during average 12 months)]
- Response rate defined by a complete response (CR), a partial response (PR) or a stable disease (SD) according to the RECIST v1.1
evaluated every 6 weeks during treatment to progression or death for any cause.(during average 12 months)]
Overall survival (OS)
Tidsramme: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months.
Incidence of Treatment-Emergent Adverse Events according to the NCI CTC AE version 4.0
Tidsramme: From date of treatment start until end of study participation (during average 12 months)]
Toxicities
From date of treatment start until end of study participation (during average 12 months)]
Peak Plasma Concentration of ABT-263
Tidsramme: 8-hour post-dose PK on D1 of C1 & 2. Dosage will be done within 12 months after end of inclusions
8-hour post-dose PK on D1 of C1 & 2. Dosage will be done within 12 months after end of inclusions
Residual concentration of ABT-263
Tidsramme: Pre-dose 0 and cycles 3, 4, 6 . Dosage will be done within 12 months after end of inclusions
Pre-dose 0 and cycles 3, 4, 6 . Dosage will be done within 12 months after end of inclusions

Samarbejdspartnere og efterforskere

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

Sponsor

Centre Francois Baclesse

Samarbejdspartnere

ARCAGY/ GINECO GROUP
French Cancer Research Hospital Program

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 (Faktiske)

1. januar 2016

Primær færdiggørelse (Faktiske)

1. april 2017

Studieafslutning (Faktiske)

1. marts 2019

Datoer for studieregistrering

Først indsendt

14. oktober 2015

Først indsendt, der opfyldte QC-kriterier

28. oktober 2015

Først opslået (Skøn)

29. oktober 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. marts 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. marts 2019

Sidst verificeret

1. marts 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2015-000193-35

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 ABT-263

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Pakistan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner