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

3. november 2020 oppdatert av: 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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

84

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Den russiske føderasjonen
      • Moscow, Den russiske føderasjonen, 125367
        • Central Clinical Hospital #1
      • Moscow, Den russiske føderasjonen, 115478
        • Russian Oncology Research Centre n.a. Blokhin, RAMS
      • Moscow, Den russiske føderasjonen, 129128
        • NUZ Semashko Central Clinical Hospital
      • St Petersburg, Den russiske føderasjonen, 198255
        • St-Petersburg State Institution of Public Health
      • St-Petersburg, Den russiske føderasjonen, 194291
        • Federal State Institution of Healthcare Clinical Hospital # 122 n.a.L.G Sokolov
      • Tula, Den russiske føderasjonen, 300053
        • Tula Regional Oncology Dispensary
    • Kaluga
      • Obninsk, Kaluga, Den russiske føderasjonen, 249030
        • Medical Radiological Research Centre
    • Tatarstan
      • Kazan, Tatarstan, Den russiske føderasjonen, 4200111
        • Kazan State Medical University
  • Frankrike
      • Saint Grégoire, Frankrike, 35768
        • Centre Hospitalier Privé Saint Grégoire
    • Cedex
      • Colmar, Cedex, Frankrike, 68024
        • Hôpitaux civils de Colmar
      • Lyon, Cedex, Frankrike, 69437
        • Hôpital Edouard Herriot
      • Rennes, Cedex, Frankrike, 35042
        • Service d'Oncologie Médicale
  • Italia
      • Genova, Italia
        • Ospedale San Martino
      • Lecce, Italia
        • Unita Operativa di Oncologia Medica
      • Siena, Italia, 53100
        • Policlinico Santa Maria alle Scotte
      • Udine, Italia, 33100
        • Azienda Ospedaliero Universitaria Santa Maria della Misericordia
    • Torino
      • Candiolo, Torino, Italia, 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.
  • Spania
      • Pamplona, Spania, 31008
        • Clinica Universitaria de Navarra
      • Terrassa (Barcelona), Spania, 08221
        • Hospital Mútua de Terrassa
    • Villaroel
      • Barcelona, Villaroel, Spania, 170
        • H.Clinic I Provincial de Barcelona
  • Storbritannia
      • Aberdeen, Storbritannia, AB25 2ZN
        • Aberdeen Royal Infirmary
      • London, Storbritannia, EC1A 7BE
        • St.Bartholomew's Hospital
      • London, Storbritannia, NW1 2PQ
        • UCLH Cancer Clinical Trials Unit
      • Manchester, Storbritannia, M20 4BX
        • Christie Hospital
    • Middlesex
      • Northwood, Middlesex, Storbritannia, HA6 2RN
        • Mount Vernon Cancer Centre
  • Tsjekkia
      • Brno, Tsjekkia, 62500
        • Fakulti nemocnice Brno
      • Olomouc, Tsjekkia, 77520
        • Fakultni Nemocnice Olomouc
      • Znojmo, Tsjekkia, 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
  • Ukraina
      • Kiev, Ukraina, 03115
        • Kyiv City Oncology Hospital
      • Sumy, Ukraina, 40005
        • Sumy Regional Oncology Center
    • Volyn
      • Lutsk, Volyn, Ukraina
        • Volyn Regional Oncology Dispensary

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: CS-7017
Legemiddel: CS-7017
CS-7017
Placebo komparator: Placebo
Placebo matching CS-7017
Legemiddel: Placebo
Placebo

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Daiichi Sankyo, Inc.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

31. juli 2009

Primær fullføring (Faktiske)

29. oktober 2012

Studiet fullført (Faktiske)

29. oktober 2012

Datoer for studieregistrering

Først innsendt

29. september 2009

Først innsendt som oppfylte QC-kriteriene

29. september 2009

Først lagt ut (Anslag)

30. september 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. november 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. november 2020

Sist bekreftet

1. november 2020

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CS7017-A-E201

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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.

Tilgangskriterier for IPD-deling

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 Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • CSR

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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