Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Study of CS-7017 in Colorectal Cancer Patients Who Have Achieved Disease Control Following First-Line Chemotherapy

3. november 2020 opdateret af: Daiichi Sankyo, Inc.

A Randomized, Double-Blind Placebo-Controlled Phase 2 Study of CS-7017 in Colorectal Cancer Patients Who Have Achieved Disease Control Following First-Line Chemotherapy

Monotherapy treatment with CS-7017 to assess progression-free-survival (PFS) of subjects who achieved an objective response of Disease Control on first line therapy with Folinic acid (leucovorin), Fluorouracil (5-FU), Oxaliplatin (Eloxatin) known as FOLFOX; or Folinic acid (leucovorin), Fluorouracil (5-FU), irinotecan (Camptosar) known as FOLFIRI.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

84

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Den Russiske Føderation
      • Moscow, Den Russiske Føderation, 125367
        • Central Clinical Hospital #1
      • Moscow, Den Russiske Føderation, 115478
        • Russian Oncology Research Centre n.a. Blokhin, RAMS
      • Moscow, Den Russiske Føderation, 129128
        • NUZ Semashko Central Clinical Hospital
      • St Petersburg, Den Russiske Føderation, 198255
        • St-Petersburg State Institution of Public Health
      • St-Petersburg, Den Russiske Føderation, 194291
        • Federal State Institution of Healthcare Clinical Hospital # 122 n.a.L.G Sokolov
      • Tula, Den Russiske Føderation, 300053
        • Tula Regional Oncology Dispensary
    • Kaluga
      • Obninsk, Kaluga, Den Russiske Føderation, 249030
        • Medical Radiological Research Centre
    • Tatarstan
      • Kazan, Tatarstan, Den Russiske Føderation, 4200111
        • Kazan State Medical University
  • Det Forenede Kongerige
      • Aberdeen, Det Forenede Kongerige, AB25 2ZN
        • Aberdeen Royal Infirmary
      • London, Det Forenede Kongerige, EC1A 7BE
        • St.Bartholomew's Hospital
      • London, Det Forenede Kongerige, NW1 2PQ
        • UCLH Cancer Clinical Trials Unit
      • Manchester, Det Forenede Kongerige, M20 4BX
        • Christie Hospital
    • Middlesex
      • Northwood, Middlesex, Det Forenede Kongerige, HA6 2RN
        • Mount Vernon Cancer Centre
  • Frankrig
      • Saint Grégoire, Frankrig, 35768
        • Centre Hospitalier Privé Saint Grégoire
    • Cedex
      • Colmar, Cedex, Frankrig, 68024
        • Hôpitaux civils de Colmar
      • Lyon, Cedex, Frankrig, 69437
        • Hôpital Edouard Herriot
      • Rennes, Cedex, Frankrig, 35042
        • Service d'Oncologie Médicale
  • Italien
      • Genova, Italien
        • Ospedale San Martino
      • Lecce, Italien
        • Unita Operativa di Oncologia Medica
      • Siena, Italien, 53100
        • Policlinico Santa Maria alle Scotte
      • Udine, Italien, 33100
        • Azienda Ospedaliero Universitaria Santa Maria della Misericordia
    • Torino
      • Candiolo, Torino, Italien, 10060
        • Institute for Cancer Research and Treatment - IRCC
  • Polen
      • Bialystok, Polen, 15-027
        • Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie w Bialymstoku
      • Bytom, Polen, 41-902
        • Wojewodzki Szpital Specjalistyczny
      • Gliwice, Polen, 44-101
        • Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie
      • Krakow, Polen, 31-108
        • VESALIUS Sp. z o.o.
      • Warszawa, Polen, 01-002
        • NZOZ ONKOLOG s.c.
  • Spanien
      • Pamplona, Spanien, 31008
        • Clinica Universitaria de Navarra
      • Terrassa (Barcelona), Spanien, 08221
        • Hospital Mútua de Terrassa
    • Villaroel
      • Barcelona, Villaroel, Spanien, 170
        • H.Clinic I Provincial de Barcelona
  • Tjekkiet
      • Brno, Tjekkiet, 62500
        • Fakulti nemocnice Brno
      • Olomouc, Tjekkiet, 77520
        • Fakultni Nemocnice Olomouc
      • Znojmo, Tjekkiet, 66902
        • Nemocnice Znojmo, p.o., Oddeleni radiacni a klinicke onkologie
  • Tyskland
      • Donauwörth, Tyskland, 86609
        • Onkologische Praxis Donauwörth
      • Halle, Tyskland, 06120
        • Universitätsklinikum Halle Klinik und Poliklinik für Innere Medizin
      • München, Tyskland, 81675
        • Klinikum rechts der Isar
  • Ukraine
      • Kiev, Ukraine, 03115
        • Kyiv City Oncology Hospital
      • Sumy, Ukraine, 40005
        • Sumy Regional Oncology Center
    • Volyn
      • Lutsk, Volyn, Ukraine
        • Volyn Regional Oncology Dispensary

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:

  • Patients with histologically confirmed, metastatic CRC that have achieved confirmed maximal benefit of DC following treatment with standard first line chemotherapy of a 5-fluoropyrimidine plus either oxaliplatin or irinotecan. Patients should be entered onto this trial within 8 weeks of completing first line therapy;
  • If CR was not achieved: measurable disease, i.e. at minimum one unidimensionally-measurable target lesion according to RECIST (Response Evaluation Criteria in Solid Tumors);
  • Age >= 18 years and Eastern Cooperative Oncology Group (ECOG) performance status (PS) =< 2 at study entry;
  • Resolution of any toxic effects of prior therapy (except alopecia) to NCI CTCAE, Version 3.0, grade =< 1;

  • Adequate organ and bone marrow function as evidenced by:

    • Haemoglobin >= 10 g/dL (transfusion and/or growth factor support allowed);
    • Absolute neutrophil count (ANC) >= 1.5 x 109/L;
    • Platelet count >= 100 x 109/L;
    • Serum creatinine =< 1.5 x ULN or creatinine clearance >60 mL/min;
    • AST and alkaline phosphatase <2.5 x ULN if without liver metastasis and =< 5.0 x ULN if liver metastasis;
    • Total bilirubin =< 2.0 x ULN;
    • Prothrombin time (PT)/International Normalised Ratio (INR) within normal limits (WNL) unless therapeutically anticoagulated;
  • Women of childbearing potential and men must be willing to consent to using highly effective methods of contraception (eg, hormonal contraceptives, bilateral tubal ligation, barrier with spermicide, intrauterine device) while on treatment and for at least 3 months thereafter;
  • Males with the potential to father children must use two of the following methods of contraception acceptable for the study (e.g. hormonal contraceptives, bilateral tubal ligation, barrier with spermicide, intrauterine device) while on trial treatment and for at least 3 months thereafter.
  • All female subjects of childbearing potential must have a negative pregnancy test (plasma or urine) result within 7 days before initiating study treatment;
  • Baseline laboratory tests and tumor assessments must have been performed within 2 weeks before initiating study treatment;
  • Subjects must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects) and must sign and date an IEC-approved ICF before performance of any study specific procedures or tests.

Exclusion Criteria:

  • Anticipation of need for a major surgical procedure or RT during the study;
  • Treatment with chemotherapy, hormonal therapy, minor surgery, or any investigational agent within 4 weeks before study enrolment. Treatment with immunotherapy, biological therapy, or major surgery within 6 weeks before study enrolment. Treatment with RT within 1 week before study enrolment.
  • History of any of the following conditions: diabetes mellitus requiring treatment with insulin or oral agents;
  • Concomitant use of other TZDs;
  • Myocardial infarction with significant impairment of cardiac function (e.g., ejection fraction =< 50%); severe/unstable angina pectoris; coronary/peripheral artery bypass graft; congestive heart failure; cerebrovascular accident (CVA) or transient ischemic attack (TIA), pulmonary embolism, or other clinically significant thromboembolic event; clinically significant pulmonary disease (e.g., severe chronic obstructive pulmonary disease [COPD] or asthma);
  • Brain metastasis; an uncontrolled seizure disorder; spinal cord compression; or carcinomatous meningitis;
  • Pleural or pericardial effusion. Subjects with minimal pleural effusion may be eligible upon request by Investigator and approval by Sponsor;
  • Clinically significant active infection that requires antibiotic therapy or Human Immunodeficiency Virus (HIV) positive subjects receiving antiretroviral therapy;
  • Pregnant or breast feeding;
  • Known history of severe hypersensitivity reactions to any of the components of CS 7017 formulations;
  • Serious intercurrent medical or psychiatric illnesses or any other conditions that in the opinion of the Investigator would impair the ability to give informed consent or unacceptably reduce protocol compliance or safety of the study treatment;

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: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: CS-7017
Medicin: CS-7017
CS-7017
Placebo komparator: Placebo
Placebo matching CS-7017
Medicin: Placebo
Placebo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage Rate of Progression-free Survival at 18 Weeks Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy
Tidsramme: 18 weeks postdose
Progression-free survival (PFS) was defined as the time from enrollment to the date of the first objective documentation of disease progression or death resulting from any cause, whichever comes first. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as at least a 20% increase in the sum of diameters of target lesions.
18 weeks postdose

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage Rate of Progression-free Survival Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy
Tidsramme: At 12, 24, and 30 weeks postdose
Progression-free survival (PFS) was defined as the time from enrollment to the date of the first objective documentation of disease progression or death resulting from any cause, whichever comes first. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as at least a 20% increase in the sum of diameters of target lesions.
At 12, 24, and 30 weeks postdose
Percentage Rate of Overall Survival Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy
Tidsramme: At 3, 6, 9, and 12 months postdose
Overall survival (OS) was defined as the time from the date of enrollment to the date of death and assessed by Kaplan Meier analysis.
At 3, 6, 9, and 12 months postdose
Best Overall Response and Objective Response Rate Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy
Tidsramme: From baseline up to disease progression or the development of unacceptable toxicity (whichever occurs first), up to approximately 3 years 3 months
The best overall response was defined as the best response (in the order of confirmed complete response [CR], confirmed partial response [PR], unconfirmed CR, unconfirmed PR, stable disease [SD], and progressive disease [PD]) among all overall responses recorded from the start of treatment until the participant withdrew from the study. If there was no tumor assessment after the first dose of study drug, the best overall response was classified as Inevaluable. Based on RECIST v1.0, CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.
From baseline up to disease progression or the development of unacceptable toxicity (whichever occurs first), up to approximately 3 years 3 months
Duration of Response for Responding Participants Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy
Tidsramme: From the date of first objective response (confirmed and unconfirmed CR or PR) to date of progressive disease, up to 3 years 3 months
Duration of response was defined for participants with confirmed CR or PR and confirmed and unconfirmed CR or PR as the time from the date of the first documentation of objective response (CR or PR) to the date of the first documentation of progressive disease. Duration of SD was defined for participants whose best response was SD as the time from the randomization date to the date of the first documentation of progressive disease. Duration of response was estimated using Kaplan Meier methods.
From the date of first objective response (confirmed and unconfirmed CR or PR) to date of progressive disease, up to 3 years 3 months
Number of Participants With Treatment-Emergent Adverse Events Related to Study Drug With an Incidence of ≥5% Following Use of CS-7017 Or Placebo in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy
Tidsramme: Baseline up to 30 days after last study dose, up to 3 years 3 months
A treatment-emergent adverse event (TEAE) was defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event that occurs more than 30 days after the last dose of study medication is not included as a TEAE unless it is considered related to treatment. If relationship is missing, the AE is also considered to be related to the drug.
Baseline up to 30 days after last study dose, up to 3 years 3 months

Samarbejdspartnere og efterforskere

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

Sponsor

Daiichi Sankyo, Inc.

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)

31. juli 2009

Primær færdiggørelse (Faktiske)

29. oktober 2012

Studieafslutning (Faktiske)

29. oktober 2012

Datoer for studieregistrering

Først indsendt

29. september 2009

Først indsendt, der opfyldte QC-kriterier

29. september 2009

Først opslået (Skøn)

30. september 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. november 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. november 2020

Sidst verificeret

1. november 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CS7017-A-E201

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

IPD-delingstidsramme

Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.

IPD-delingsadgangskriterier

Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • CSR

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 .

Abonner