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

3 listopada 2020 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

84

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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;

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: CS-7017
Lek: CS-7017
CS-7017
Komparator placebo: Placebo
Placebo matching CS-7017
Lek: Placebo
Placebo

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Percentage Rate of Progression-free Survival Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Daiichi Sankyo, Inc.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

31 lipca 2009

Zakończenie podstawowe (Rzeczywisty)

29 października 2012

Ukończenie studiów (Rzeczywisty)

29 października 2012

Daty rejestracji na studia

Pierwszy przesłany

29 września 2009

Pierwszy przesłany, który spełnia kryteria kontroli jakości

29 września 2009

Pierwszy wysłany (Oszacować)

30 września 2009

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

5 listopada 2020

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

3 listopada 2020

Ostatnia weryfikacja

1 listopada 2020

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • CS7017-A-E201

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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/

Ramy czasowe udostępniania IPD

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.

Kryteria dostępu do udostępniania IPD

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.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • CSR

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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