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A Phase 1/2 Study Evaluating AMG 337 in Asian Subjects

23 december 2021 uppdaterad av: Amgen

A Multicenter, Phase 1/2, Open-Label Study Evaluating the Tolerability, Safety, Pharmacokinetics, and Efficacy of AMG 337 in Asian Subjects

This is a multicenter, Phase 1/2 study. The study will evaluate the tolerability, safety and activity of AMG 337 in Asian subjects who have advanced solid tumors (Phase 1) or subjects with MET amplified tumors with a focus on gastric/gastroesophageal junction/esophageal adenocarcinoma (Phase 2).

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

This is a Phase 1/2, multicenter, single arm, open-label study to assess the safety, efficacy and pharmacokinetics of AMG 337 in solid tumors. In the Phase 1, approximately 3 to 45 subjects enrolled in a 3+3+3 dose escalation scheme evaluating two dose levels. In the Phase 2, approximately 140 subjects will be enrolled to either Cohort 1 (subjects with MET amplified /gastroesophageal junction/esophageal (G/GEJ/E) adenocarcinoma with measurable tumor) or Cohort 2 (subjects with MET amplified solid tumors with measurable tumor and subjects with MET amplified G/GEJ/E adenocarcinoma with non-measurable tumor). All subjects will self-administer AMG 337 daily until disease progression or other protocol specified end of treatment criteria are met. Tumor assessment by RECIST 1.1 will be followed during study treatment.

Tumor tissue, biomarkers, pharmacokinetics and Patient Reported Outcomes will be assessed.

Studietyp

Interventionell

Inskrivning (Faktisk)

11

Fas

  • Fas 2
  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Japan
    • Chiba
      • Kashiwa-shi, Chiba, Japan, 277-8577
        • Research Site
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan, 060-8648
        • Research Site
    • Kanagawa
      • Kawasaki-shi, Kanagawa, Japan, 216-8511
        • Research Site
    • Shizuoka
      • Suntou-gun, Shizuoka, Japan, 411-8777
        • Research Site

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

20 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Able to self administer daily AMG 337 as a whole capsule
  • Male or female 20 years of age or over
  • Phase 1: Subjects must have a pathologically confirmed, advanced solid tumor for which the subjects have received prior therapy for advanced disease, for which no standard therapy exists, or the subject refuses standard therapy.
  • Phase 2: Subjects must have a pathologically confirmed, advanced G/GEJ/E adenocarcinoma (cohort 1) or other solid tumor (cohort 2) for which the subjects have received prior therapy for advanced disease, or for which no standard therapy exists, or the subject refuses standard therapy.
  • Tumor MET amplified by protocol-specified centralized testing (phase 2 only).
  • Phase 1: Measurable or non-measurable disease per RECIST v1.1
  • Phase 2: Measurable disease per RECIST v1.1 guidelines. Cohort 2 may include subjects with advanced MET amplified G/GEJ/E adenocarcinoma with non-measurable tumor per RECIST v1.1.
  • (ECOG) Performance Status of 0, 1, or 2
  • Other protocol defined inclusion criteria may apply.

Exclusion Criteria:

  • Known central nervous system metastases.
  • Subject is a candidate for curative surgery or definitive chemoradiation.
  • Peripheral edema > grade 1.
  • Subjects who have persistent gastric outlet obstruction, complete dysphagia or are dependent upon jejunostomy for feeding. Significant gastrointestinal disorder(s) that in the opinion of the Investigator may influence drug absorption.
  • Currently receiving any anti-tumor treatments, or less than 14 days prior to enrollment since ending anti-tumor treatment.
  • Prior treatment with small molecule inhibitors of the MET pathway.
  • Other protocol defined exclusion criteria may apply.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Enkelarm
Läkemedel: AMG 337
Phase 1- AMG 337 150 mg, 200mg and 300 mg orally daily. Additional 150 mg and 200 mg orally twice daily. Phase 2- AMG 337 (dose determined by Phase 1)

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Phase 1- Adverse events and clinical laboratory abnormalities
Tidsram: 17 months
Adverse events and clinical laboratory abnormalities defined as DLTs.
17 months
Phase 2- Overall Response Rate (per RECIST v1.1) in subjects with MET amplified measurable gastric/gastroesophageal junction/esophageal adenocarcinoma (cohort 1)
Tidsram: 17 months
Determine anti-tumor activity of AMG 337 in subjects with MET amplified gastric/gastroesophageal junction/esophageal adenocarcinoma (cohort 1)
17 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Phase 1- Pharmacokinetic parameters
Tidsram: 17 months
Including, but not limited to, minimum (trough) concentrations, maximum concentrations (C max), the time of C max (t max), and area under the plasma concentration- time curve (AUC).
17 months
Phase 1- Other adverse events, clinical laboratory abnormalities and ECG parameters
Tidsram: 17 months
17 months
Phase 2- Overall Response Rate (per RECIST v1.1) in subjects with other MET amplified solid tumors (subjects with measurable disease in cohort 2)
Tidsram: 17 months
Determine anti-tumor activity in AMG 337 in subjects with MET amplified solid tumors (subjects with measurable disease in cohort 2)
17 months
Phase 2- Duration of Response (cohort 1 and subjects with measurable disease at baseline in cohort 2)
Tidsram: 17 months
17 months
Phase 2- Time to response (cohort 1 and subjects with measurable disease at baseline in cohort 2)
Tidsram: 17 months
17 months
Phase 2- Progression Free Survival
Tidsram: 17 months
17 months
Phase 2- Overall Survival
Tidsram: 17 months
17 months
Phase 2- Incidence and severity of adverse events and significant laboratory abnormalities
Tidsram: 17 months
17 months
Phase 2- AMG 337 exposure and dose intensity
Tidsram: 17 months
17 months
Phase 2- Pharmacokinetic parameters
Tidsram: 17 months
Including, but not limited to, minimum (trough) concentrations at pre-dose times and maximum concentrations (C max), the time of C max (t max), and area under the plasma concentration- time curve (AUC) for intensive pharmacokinetic sampling.
17 months
Phase 1- Overall Response Rate
Tidsram: 17 months
17 months
Phase 1- Duration of Response
Tidsram: 17 months
17 months
Phase 1- Time to Response
Tidsram: 17 months
17 months
Phase 1- Progression-Free Survival (per RECIST v1.1)
Tidsram: 17 months
17 months
Phase 1- Overall Survival
Tidsram: 17 months
17 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Amgen

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

15 april 2014

Primärt slutförande (Faktisk)

5 november 2015

Avslutad studie (Faktisk)

7 december 2018

Studieregistreringsdatum

Först inskickad

24 mars 2014

Först inskickad som uppfyllde QC-kriterierna

24 mars 2014

Första postat (Uppskatta)

26 mars 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

28 december 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 december 2021

Senast verifierad

1 december 2021

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 20120370

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Tidsram för IPD-delning

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

Kriterier för IPD Sharing Access

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF
  • CSR

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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