- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04836663
A Study of TQ-B3525 Tablets in Subjects With PIK3CA and/or PIK3R1/2 Gene-altered Recurrent/Metastatic Advanced Gynecologic Tumors
A Open-label, Multicenter Phase II Study of TQ-B3525 Tablets in Subjects With PIK3CA and/or PIK3R1/2 Gene-altered Recurrent/Metastatic Advanced Gynecologic Tumors
연구 개요
상태
개입 / 치료
연구 유형
등록 (예상)
단계
- 2 단계
연락처 및 위치
연구 장소
-
-
Jiangsu
-
Changzhou, Jiangsu, 중국, 213003
- 아직 모집하지 않음
- The First People's Hospital of Changzhou
-
연락하다:
- Weiqing Zhao, Doctor
- 이메일: zwq7860@163.com
-
수석 연구원:
- Weiqing Zhao, Doctor
-
Nanjing, Jiangsu, 중국
- 아직 모집하지 않음
- Nanjing Drum Tower Hospital
-
연락하다:
- Huaijun Zhou, Doctor
- 이메일: zhouhj2007@126.com
-
수석 연구원:
- Huaijun Zhou, Doctor
-
-
Shanghai
-
Shanghai, Shanghai, 중국, 200032
- 모병
- Fudan University Shanghai Cancer Center
-
연락하다:
- Xiaohua Wu, Doctor
- 이메일: wu.xh@fudan.edu.cn
-
수석 연구원:
- Xiaohua Wu, Doctor
-
Shanghai, Shanghai, 중국, 200090
- 아직 모집하지 않음
- Gynecology Hospital of Fudan University
-
연락하다:
- Xiaojun Chen, Doctor
- 이메일: cxjlhjj@163.com
-
수석 연구원:
- Xiaojun Chen, Doctor
-
-
Zhejiang
-
Hangzhou, Zhejiang, 중국, 310016
- 아직 모집하지 않음
- Sir Run Run Shaw Hospital Medical School Zhejiang University
-
연락하다:
- Xian Wang, Doctor
- 이메일: yedw@srrsh.com
-
수석 연구원:
- Xian Wang, Doctor
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
1. Pathologically confirmed malignant gynecological neoplasm. 2. Has PIK3CA and/or PIK3R1/2 Gene-altered. 3.Unresectable, locally advanced recurrent and/or metastatic tumors, has at least 1 measurable lesion.
4.Failed with standard treatment or has no effective treatment. 5. 18 years and older, Eastern Cooperative Oncology Group(ECOG) performance status score of 0 to 1, Life expectancy ≥ 3 months.
6. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ;No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the first administration.
7.Understood and signed an informed consent form.
Exclusion Criteria:
1.Has untreated or active central nervous system metastases. 2.Has diagnosed and/or treated additional malignancy within 3 years prior to the first administration.
3. Insufficient hematopoietic function of bone marrow. 4. Dysfunction of liver and kidney. 5. Bleeding risk. 6. Dysfunction of gastrointestinal tract. 7.Dysfunction of heart and cerebral vessels. 8.Has received PI3K, AKT, mTOR inhibitor. 9.Has participated in other clinical trails within 30 days. 10. Has received surgery, or unhealed wounds within 4 weeks before the first administration.
11. Has received organ grafting, or hematopoietic stem cell transplantation within 60 days before the first administration, or host versus graft reaction.
12. The patients required immunosuppressor, or the whole-body, or absorbable local hormone therapy for immunosuppression purposes and continued to use within 7 days before the initial administration (daily dose of glucocorticoid <10 mg, except metacortandracin or other therapeutic hormones and so on).
13. Has active infections. 14. Has human immunodeficiency virus (HIV). 15. Pregnant or lactating women. 16. Has psychotropic substances abuse or a mental disorder. 17. Has other conditions that make it inappropriate for the patient to be enrolled based on investigator's opinion.
18. Patient's compliance is inadequate.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: TQ-B3525 tablet
|
TQ-B3525 tablet administered orally once a day.
Each cycle is 28 days.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Overall response rate (ORR) assessed by Independent Review Committee
기간: up to 48 weeks
|
Percentage of participants achieving complete response (CR) and partial response (PR) based on IRC.
|
up to 48 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Overall response rate (ORR) assessed by Investigator
기간: up to 48 weeks
|
Percentage of participants achieving complete response (CR) and partial response (PR) assessed by investigator.
|
up to 48 weeks
|
방역률(DCR)
기간: 최대 48주
|
완전 반응(CR) 및 부분 반응(PR) 및 안정 질환(SD)을 달성한 대상체의 백분율.
|
최대 48주
|
Duration of disease remission (DOR)
기간: up to 48 weeks
|
The time from the first evaluation of the subject as CR or PR to the first evaluation of the subject as PD or death (whichever occurs first).
|
up to 48 weeks
|
Progression-free survival (PFS)
기간: up to 48 weeks
|
PFS was defined as the time from the date of study enrollment to the date of the first of the following events, objective disease progression or death due to any cause.
|
up to 48 weeks
|
Overall survival (OS)
기간: up to 72 weeks
|
OS defined as the time from the first dose to death from any cause.
Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up.
|
up to 72 weeks
|
DOR rate (≥ 6 months) (percentage of subjects with disease remission duration ≥ 6 months)
기간: up to 48 weeks
|
The percentage of subjects achieving CR or PR was recorded for the first time to 6 months after the first time of objective tumor progression or death due to any cause (whichever occurred first) was recorded.
|
up to 48 weeks
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
TQ-B3525 tablet에 대한 임상 시험
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.모병
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.알려지지 않은
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.모병
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.아직 모집하지 않음
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.알려지지 않은
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.알려지지 않은
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.종료됨
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.모병
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.알려지지 않은HR 양성, HER2 음성 및 PIK3CA 돌연변이 진행성 유방암중국