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

2020年11月3日 更新者：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.

調査の概要

状態

終了しました

条件

介入・治療

研究の種類

介入

入学 (実際)

84

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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;

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：トリプル

武器と介入

参加者グループ / アーム
介入・治療
実験的：CS-7017
薬：CS-7017
CS-7017
プラセボコンパレーター：Placebo
Placebo matching CS-7017
薬：プラセボ
プラセボ

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Percentage Rate of Progression-free Survival Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Daiichi Sankyo, Inc.

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2009年7月31日

一次修了 (実際)

2012年10月29日

研究の完了 (実際)

2012年10月29日

試験登録日

最初に提出

2009年9月29日

QC基準を満たした最初の提出物

2009年9月29日

最初の投稿 (見積もり)

2009年9月30日

学習記録の更新

投稿された最後の更新 (実際)

2020年11月5日

QC基準を満たした最後の更新が送信されました

2020年11月3日

最終確認日

2020年11月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • CS7017-A-E201

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有時間枠

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 共有アクセス基準

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 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • CSR

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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