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Cipterbin Combined With Vinorelbine in the Treatment of HER2-positive MBC

2021년 11월 11일 업데이트: wangxiaojia, Zhejiang Cancer Hospital

A Multi-center, Randomized, Open-label Study on Pharmacokinetics, Safety, Efficacy, and Immunogenicity of Cipterbin Combined With Vinorelbine Injection Every Week or Every Three Weeks in the Treatment of Patients With HER2-positive Metastatic Breast Cancer

To compare pharmacokinetics Index of Cipterbin combined with Vinorelbine Injection every week or every three weeks in the treatment of patients with HER2-positive metastatic breast cancer

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

A multi-center, randomized, open-label study on pharmacokinetics, safety, efficacy, and immunogenicity of Cipterbin combined with Vinorelbine Injection every week or every three weeks in the treatment of patients with HER2-positive metastatic breast cancer. The main purpose was to compare pharmacokinetics Index between two groups, secondly to observe safety, efficacy, and immunogenicity

연구 유형

중재적

등록 (예상)

60

단계

  • 4단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 중국
    • Zhejiang
      • Hangzhou, Zhejiang, 중국, 310000
        • 모병
        • Zhejiang Cancer Hospital
        • 연락하다:

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 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

설명

Inclusion Criteria:

  • Age ≥18 and ≤70 years old, female.
  • BMI index in the range of 19.0~28.0
  • ECOG≤1, and the expected os ≥3 months
  • Unresectable metastatic breast cancer diagnosed by histology or pathology that has received one or more chemotherapy regimens.
  • HER2 overexpression is +++ by immunohistochemistry (IHC) or + by fluorescence hybridization FISH.
  • At least one measurable lesion.
  • Sufficient organ function
  • Voluntarily signed an informed consent form.
  • Subjects with good compliance

Exclusion Criteria:

  • Rapid disease progression or threaten important organs and require urgent replacement therapy.
  • Undergone surgery within 28 days before treatment (except for biopsy)
  • Received radiotherapy within 21 days before the first study drug treatment or the side effects of radiotherapy have not recovered to 0 or 1
  • Suffer from other serious uncontrolled diseases (such as epilepsy, liver failure, kidney failure, etc.)
  • Suffered from other malignant tumors within 5 years before receiving the first study drug treatment or at the same time.
  • Severely infected
  • Clear history of mental illness, or have a history of alcoholism or drug abuse.
  • Central nervous system metastasis or meningeal metastasis with clinical symptoms
  • Cardiac function left ventricular ejection fraction < 50%
  • Obvious arrhythmia, myocardial ischemia, severe atrioventricular block, cardiac insufficiency, severe heart valve Membrane disease patients
  • Poorly controlled hypertension
  • Patients with coagulopathy: INR or APTT ≥1.5×ULN
  • Allergic to the test drug or its excipients in the study treatment, or have a severe allergic reaction to other monoclonal antibody drugs in the past
  • Pregnant or breastfeeding, or cannot take reliable contraceptive measures during the trial and within 6 months after the end of the medication Giver
  • Have received a certain test drug in other interventional clinical trials, the interval is less than 28 days or less than 5 half lives of the drug (whichever is longer)
  • Have used a monoclonal antibody within 6 months before receiving the first study drug treatment
  • Have received other drugs that may affect the pharmacokinetic results of the study drug, the interval is less than 28 days or less than 5 half lives of the drug (whichever is longer)
  • Have received organ transplants (including autologous/allologous stem cell transplants) in the past
  • Other conditions judged by the investigator to be inappropriate for participating in this trial

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: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: One-week group
Cipterbin combined with Vinorelbine Injection every week in the treatment of patients with HER2-positive metastatic breast cancer
의약품: Cipterbin Combined With Vinorelbine
  1. Cipterbin combined with Vinorelbine Injection every week in the treatment of patients with HER2-positive metastatic breast cancer
  2. Cipterbin combined with Vinorelbine Injection every three weeks in the treatment of patients with HER2-positive metastatic breast cancer
실험적: Three-week group
Cipterbin combined with Vinorelbine Injection every three weeks in the treatment of patients with HER2-positive metastatic breast cancer
의약품: Cipterbin Combined With Vinorelbine
  1. Cipterbin combined with Vinorelbine Injection every week in the treatment of patients with HER2-positive metastatic breast cancer
  2. Cipterbin combined with Vinorelbine Injection every three weeks in the treatment of patients with HER2-positive metastatic breast cancer

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Cmax
기간: From enrollment to 21 days after the last dose administrate
Cmax after the last administration
From enrollment to 21 days after the last dose administrate
Cmin
기간: From enrollment to 21 days after the last dose administrate
Cmin after the last administration
From enrollment to 21 days after the last dose administrate
AUC0-t
기간: From enrollment to 21 days after the last dose administrate
AUC0-t after the last administration
From enrollment to 21 days after the last dose administrate
AUCtau
기간: From enrollment to 21 days after the last dose administrate
AUCtau after the last administration
From enrollment to 21 days after the last dose administrate

2차 결과 측정

결과 측정
측정값 설명
기간
Multiple sets of Cmax
기간: From enrollment to 21 days after the last dose administrate
Cmax after the first administration and the third administration in the three-week administration group and the seventh administration in the one-week administration group.
From enrollment to 21 days after the last dose administrate
Multiple sets of Cmin
기간: From enrollment to 21 days after the last dose administrate
Cmin after the first administration and the third administration in the three-week administration group and the seventh administration in the one-week administration group.
From enrollment to 21 days after the last dose administrate
Multiple sets of AUC0-t
기간: From enrollment to 21 days after the last dose administrate
AUC0-t after the first administration and the third administration in the three-week administration group and the seventh administration in the one-week administration group.
From enrollment to 21 days after the last dose administrate
Multiple sets of AUCtau
기간: From enrollment to 21 days after the last dose administrate
AUCtau after the first administration and the third administration in the three-week administration group and the seventh administration in the one-week administration group.
From enrollment to 21 days after the last dose administrate
Multiple sets of Tmax
기간: From enrollment to 21 days after the last dose administrate
Tmax after the first administration and the third administration in the three-week administration group and the seventh administration in the one-week administration group.
From enrollment to 21 days after the last dose administrate
Safety index
기간: From enrollment to 30 days after the last dose administrate
Adverse Events during the test
From enrollment to 30 days after the last dose administrate
BOR
기간: From enrollment to death(for any reason),Until 24 months after the last subject left the administration group
Record the proportion of CR and PR in all subjects
From enrollment to death(for any reason),Until 24 months after the last subject left the administration group
DCR
기간: From enrollment to death(for any reason),Until 24 months after the last subject left the administration group
CR/PR/SD accounted for the proportion of all subjects
From enrollment to death(for any reason),Until 24 months after the last subject left the administration group
OS
기간: From enrollment to death(for any reason),Until 24 months after the last subject left the administration group
Overall Survival of all subjects
From enrollment to death(for any reason),Until 24 months after the last subject left the administration group
Immunogenicity index
기간: From enrollment to 21 days after the last dose administrate
ADA
From enrollment to 21 days after the last dose administrate

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Zhejiang Cancer Hospital

협력자

Proswell Medical Corporation

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)

2021년 1월 4일

기본 완료 (예상)

2022년 12월 30일

연구 완료 (예상)

2022년 12월 30일

연구 등록 날짜

최초 제출

2021년 9월 3일

QC 기준을 충족하는 최초 제출

2021년 11월 11일

처음 게시됨 (실제)

2021년 11월 23일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 11월 23일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 11월 11일

마지막으로 확인됨

2021년 11월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • SSGJ-302H-mBC-IIT-01

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

The data will be shared from the trial begin for 10 years

IPD 공유 기간

From the trial begin for 10 years

IPD 공유 액세스 기준

Every one

IPD 공유 지원 정보 유형

  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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. .

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