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Study of ARQ 197 Monotherapy (ARQ 197-004)

14. marts 2017 opdateret af: Kyowa Kirin Co., Ltd.

Phase II Study of ARQ 197 Monotherapy for Previously Treated Advanced/Recurrent Gastric Cancer

A phase II open-label study with ARQ 197 administered orally and twice daily as monotherapy in patients with previously treated advanced/recurrent gastric cancer. The primary endpoint is disease control and the secondary efficacy endpoints include antitumor effect (tumor response), progression-free survival and overall survival. The pharmacokinetic profile and the safety profile are also evaluated.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

31

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

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

20 år til 74 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Japanese or Korean with voluntary written informed consent for study participation
  • A histologically or cytologically confirmed advanced/recurrent gastric cancer
  • One or two prior chemotherapy regimens for advanced/recurrent gastric cancer
  • At least one measurable lesion
  • ECOG performance status of 0 or 1
  • Life expectancy ≥3 months

Exclusion Criteria:

  • Surgery for cancer within 4 weeks prior to the first dose of ARQ 197
  • Confirmed other tumors than gastric cancer within 5 years prior to the first dose of ARQ 197
  • Anticancer chemotherapy, hormone therapy, radiotherapy or immunotherapy within 2 weeks prior to the first dose of ARQ 197
  • Positive for HIV antibody
  • Known symptomatic brain metastasis
  • Gastrointestinal disorders that could interfere with the absorption of ARQ 197 or operation history for gastrointestinal disorders
  • Uncontrolled concomitant disease
  • Patients who wish to have a child and who would not agree to use contraceptive measures
  • Pregnant or lactating

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: ARQ 197
Medicin: ARQ 197
Orally twice daily administration of ARQ 197

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Antitumor effect
Tidsramme: Tumor size was measured at Baseline, Day 29 and 54, and then every 6 week until discontinuation criteria met.
Disease control
Tumor size was measured at Baseline, Day 29 and 54, and then every 6 week until discontinuation criteria met.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Antitumor effect
Tidsramme: Tumor size was measured at Baseline, Day 29 and 54, and then every 6 week until discontinuation criteria met.
Tumor response
Tumor size was measured at Baseline, Day 29 and 54, and then every 6 week until discontinuation criteria met.
Progression-free survival
Tidsramme: Tumor size was measured at Baseline, Day 29 and 54, and then every 6 week until discontinuation criteria met. In addition, survival was confirmed by biweekly inquiry during the study, and by follow up survey.
Tumor size was measured at Baseline, Day 29 and 54, and then every 6 week until discontinuation criteria met. In addition, survival was confirmed by biweekly inquiry during the study, and by follow up survey.
Overall survival
Tidsramme: Survival was confirmed by biweekly inquiry during the study, and by follow up survey.
Survival was confirmed by biweekly inquiry during the study, and by follow up survey.
Pharmacokinetic profile
Tidsramme: Plasma sample correction at pre-dose, 1, 2, 4, 6, 10, 12 and 24 hours on Day 1, and in addition, at pre-dose of Day 15 and 29.
Plasma ARQ 197 concentrations and pharmacokinetic parameters following the first dose of ARQ 197
Plasma sample correction at pre-dose, 1, 2, 4, 6, 10, 12 and 24 hours on Day 1, and in addition, at pre-dose of Day 15 and 29.
Adverse events
Tidsramme: Patients will be monitored for occurrence of adverse events from the day of the first dosing to the completion of the examinations at the discontinuation of the study.
Patients will be monitored for occurrence of adverse events from the day of the first dosing to the completion of the examinations at the discontinuation of the study.

Samarbejdspartnere og efterforskere

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

Sponsor

Kyowa Kirin Co., Ltd.

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. juni 2010

Primær færdiggørelse (Faktiske)

1. august 2011

Studieafslutning (Faktiske)

1. august 2011

Datoer for studieregistrering

Først indsendt

25. juni 2010

Først indsendt, der opfyldte QC-kriterier

27. juni 2010

Først opslået (Skøn)

29. juni 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. marts 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. marts 2017

Sidst verificeret

1. marts 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ARQ 197-004

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 Mavekræft

Kliniske forsøg med ARQ 197

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Myanmar

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner