Study of CS-7017 in Colorectal Cancer Patients Who Have Achieved Disease Control Following First-Line Chemotherapy
2020년 11월 3일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
84
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Donauwörth, 독일, 86609
- Onkologische Praxis Donauwörth
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Halle, 독일, 06120
- Universitätsklinikum Halle Klinik und Poliklinik für Innere Medizin
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München, 독일, 81675
- Klinikum rechts der Isar
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Moscow, 러시아 연방, 125367
- Central Clinical Hospital #1
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Moscow, 러시아 연방, 115478
- Russian Oncology Research Centre n.a. Blokhin, RAMS
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Moscow, 러시아 연방, 129128
- NUZ Semashko Central Clinical Hospital
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St Petersburg, 러시아 연방, 198255
- St-Petersburg State Institution of Public Health
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St-Petersburg, 러시아 연방, 194291
- Federal State Institution of Healthcare Clinical Hospital # 122 n.a.L.G Sokolov
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Tula, 러시아 연방, 300053
- Tula Regional Oncology Dispensary
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Kaluga
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Obninsk, Kaluga, 러시아 연방, 249030
- Medical Radiological Research Centre
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Tatarstan
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Kazan, Tatarstan, 러시아 연방, 4200111
- Kazan State Medical University
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Pamplona, 스페인, 31008
- Clinica Universitaria de Navarra
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Terrassa (Barcelona), 스페인, 08221
- Hospital Mútua de Terrassa
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Villaroel
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Barcelona, Villaroel, 스페인, 170
- H.Clinic I Provincial de Barcelona
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Aberdeen, 영국, AB25 2ZN
- Aberdeen Royal Infirmary
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London, 영국, EC1A 7BE
- St.Bartholomew's Hospital
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London, 영국, NW1 2PQ
- UCLH Cancer Clinical Trials Unit
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Manchester, 영국, M20 4BX
- Christie Hospital
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Middlesex
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Northwood, Middlesex, 영국, HA6 2RN
- Mount Vernon Cancer Centre
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Kiev, 우크라이나, 03115
- Kyiv City Oncology Hospital
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Sumy, 우크라이나, 40005
- Sumy Regional Oncology Center
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Volyn
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Lutsk, Volyn, 우크라이나
- Volyn Regional Oncology Dispensary
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Genova, 이탈리아
- Ospedale San Martino
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Lecce, 이탈리아
- Unita Operativa di Oncologia Medica
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Siena, 이탈리아, 53100
- Policlinico Santa Maria alle Scotte
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Udine, 이탈리아, 33100
- Azienda Ospedaliero Universitaria Santa Maria della Misericordia
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Torino
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Candiolo, Torino, 이탈리아, 10060
- Institute for Cancer Research and Treatment - IRCC
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Brno, 체코, 62500
- Fakulti nemocnice Brno
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Olomouc, 체코, 77520
- Fakultni Nemocnice Olomouc
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Znojmo, 체코, 66902
- Nemocnice Znojmo, p.o., Oddeleni radiacni a klinicke onkologie
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Bialystok, 폴란드, 15-027
- Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie w Bialymstoku
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Bytom, 폴란드, 41-902
- Wojewodzki Szpital Specjalistyczny
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Gliwice, 폴란드, 44-101
- Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie
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Krakow, 폴란드, 31-108
- VESALIUS Sp. z o.o.
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Warszawa, 폴란드, 01-002
- NZOZ ONKOLOG s.c.
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Saint Grégoire, 프랑스, 35768
- Centre Hospitalier Privé Saint Grégoire
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Cedex
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Colmar, Cedex, 프랑스, 68024
- Hôpitaux civils de Colmar
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Lyon, Cedex, 프랑스, 69437
- Hôpital Edouard Herriot
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Rennes, Cedex, 프랑스, 35042
- Service d'Oncologie Médicale
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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;
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: CS-7017
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CS-7017
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위약 비교기: Placebo
Placebo matching CS-7017
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위약
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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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
기간: 18 weeks postdose
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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.
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18 weeks postdose
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percentage Rate of Progression-free Survival Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy
기간: At 12, 24, and 30 weeks postdose
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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.
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At 12, 24, and 30 weeks postdose
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Percentage Rate of Overall Survival Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy
기간: At 3, 6, 9, and 12 months postdose
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Overall survival (OS) was defined as the time from the date of enrollment to the date of death and assessed by Kaplan Meier analysis.
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At 3, 6, 9, and 12 months postdose
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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
기간: From baseline up to disease progression or the development of unacceptable toxicity (whichever occurs first), up to approximately 3 years 3 months
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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.
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From baseline up to disease progression or the development of unacceptable toxicity (whichever occurs first), up to approximately 3 years 3 months
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Duration of Response for Responding Participants Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy
기간: From the date of first objective response (confirmed and unconfirmed CR or PR) to date of progressive disease, up to 3 years 3 months
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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.
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From the date of first objective response (confirmed and unconfirmed CR or PR) to date of progressive disease, up to 3 years 3 months
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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
기간: Baseline up to 30 days after last study dose, up to 3 years 3 months
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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.
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Baseline up to 30 days after last study dose, up to 3 years 3 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2009년 7월 31일
기본 완료 (실제)
2012년 10월 29일
연구 완료 (실제)
2012년 10월 29일
연구 등록 날짜
최초 제출
2009년 9월 29일
QC 기준을 충족하는 최초 제출
2009년 9월 29일
처음 게시됨 (추정)
2009년 9월 30일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 11월 5일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 11월 3일
마지막으로 확인됨
2020년 11월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- CS7017-A-E201
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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 공유 기간
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 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- CSR
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .