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Phase 2 Study of KH903 in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma As Second-Line Therapy

14. september 2020 opdateret af: Chengdu Kanghong Biotech Co., Ltd.

A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase 2 Study of Weekly Paclitaxel With or Without KH903 in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma, Refractory to or Progressive After First-Line Therapy With Platinum and Fluoropyrimidine

The purpose of this study is to evaluate the efficacy and safety of the study drug known as KH903 in participants with gastric and gastroesophageal cance

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

81

Fase

  • Fase 2

Kontakter og lokationer

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

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:

  • 1.Prior to any detailed procedures of this study, subjects are able to understand, voluntarily participate in and sign the informed consent approved by the ethics committee.
  • 2.Age ≥ 18 years.
  • 3.Histologically confirmed, unresectable, locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma .
  • 4.Have at least 1 measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1.
  • 5.Have experienced documented objective radiographic or symptomatic disease progression during first-line therapy, or within 4 months after the last dose of first-line therapy with any platinum or/and fluoropyrimidine doublet for unresectable or metastatic disease.Second line chemotherapy is suitable for paclitaxel.
  • 6.Laboratory test values must meet the following criteria. ANC ≥1.5×109/L, platelets ≥ 100×109/L, hemoglobin≥9g/dL. Blood creatinine ≤ 1.5 ×ULN or creatinine clearance ≥ 50 mL/min/m2. Total bilirubin ≤ 1.5× ULN(≤ 3 x ULN if Gilbert disease), AST and ALT ≤ 2.5× ULN (≤ 5×ULN if hepatic metastasis).

INR ≤ 1.5× ULN, APTT ≤ 1.5× ULN. Dipstick proteinuria <2+ or 24 hour proteinuria <1g .

  • 7.Good performance status Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 to 1.
  • 8.Life expectancy of ≥ 3 months.

Exclusion Criteria:

  • 1.Histologically confirmed squamous cell carcinoma or undifferentiated gastric cancer.
  • 2.Patients with disease progression within 6 months after previous adjuvant or neoadjuvant chemotherapy with paclitaxel, or patients with recurrent or metastatic gastric adenocarcinoma or GEJ adenocarcinoma treated with paclitaxel.
  • 3. GI perforation and/or fistulae in the 6 months preceding randomization.
  • 4.Deep-vein thrombosis, pulmonary embolism (PE), or any other episode of Uncontrolled thromboembolism in the 6 months preceding randomization.
  • 5.Any arterial thromboembolic event (such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack)
  • 6.Uncontrolled hypertension (≥150/100 mm Hg ) despite properly observed antihypertensive therapy.
  • 7.Known brain metastasis.
  • 8.Known allergy to paclitaxel or KH903.
  • 9.Serious concurrent infection or medical illness.
  • 10.Active hepatitis B virus or Active hepatitis C virus (HCV) infection at screening.
  • 11.Any condition which results in an undue risk for the patient during the trial participation according to the investigator.

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: KH903 + Paclitaxel
IV KH903 4 mg/kg IV paclitaxel 80 mg/m²
Medicin: KH903 + Paclitaxel
KH903 4 mg/kg will be administered intravenously on D1 D8 D15and D22 in a 28-day cycle； Paclitaxel 80 mg/m² will be administered intravenously on D1, D8 and D15 in a 28-day cycle
Aktiv komparator: Placebo + Paclitaxel
IV Placebo IV paclitaxel 80 mg/m²
Medicin: Placebo + Paclitaxel
Placebo will be administered intravenously on D1 D8 D15and D22 in a 28-day cycle； Paclitaxel 80 mg/m² will be administered intravenously on D1, D8 and D15 in a 28-day cycle

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-free survival（PFS）
Tidsramme: Time from date of randomization until the date of first documented Progression or date of death from any cause， whichever came frist，assessed up to18 months
Date of randomization until the date of first documented Progression or date of death from any cause， whichever came first
Time from date of randomization until the date of first documented Progression or date of death from any cause， whichever came frist，assessed up to18 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective Response Rate (ORR)
Tidsramme: Time from date of randomization until the date of first documented CR or PR，assessed up to18 months
Percentage of Participants with a Best Overall Response (BOR) of Partial Response (PR) or Complete Response (CR)
Time from date of randomization until the date of first documented CR or PR，assessed up to18 months
Duration of Response (DOR)
Tidsramme: Time from first documented evidence of CR or PR until the date of first documented progression ，assessed up to18 months
is defined as the time from first documented evidence of CR or PR until the date of first documented progression as assessed by RECIST 1.1 or death; assessed up to18 months
Time from first documented evidence of CR or PR until the date of first documented progression ，assessed up to18 months
Disease Control Rate (DCR)
Tidsramme: Time from date of randomization until the date of first documented Progression，assessed up to18 months
Percentage of Participants who have achieved CR, PR and SD to study treatment;
Time from date of randomization until the date of first documented Progression，assessed up to18 months
AE
Tidsramme: AEs（NCI CTCAE 5.0） collected at each cycle，Assessed up to18 months
Number of Subjects with treatment-related adverse events (AEs)Defined by all
AEs（NCI CTCAE 5.0） collected at each cycle，Assessed up to18 months

Samarbejdspartnere og efterforskere

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

Sponsor

Chengdu Kanghong Biotech Co., Ltd.

Efterforskere

  • Ledende efterforsker: yi ba, PhD, Tianjin Medical University Cancer Institute and Hospital

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 (Forventet)

15. september 2020

Primær færdiggørelse (Forventet)

15. januar 2022

Studieafslutning (Forventet)

15. januar 2022

Datoer for studieregistrering

Først indsendt

5. august 2020

Først indsendt, der opfyldte QC-kriterier

14. september 2020

Først opslået (Faktiske)

18. september 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. september 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. september 2020

Sidst verificeret

1. september 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KH903-40101-CRP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Mavekræft

Kliniske forsøg med KH903 + Paclitaxel

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Betingelser

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