- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Jiangsu
-
Changzhou, Jiangsu, China, 213003
- Not yet recruiting
- The First People's Hospital of Changzhou
-
Contact:
- Weiqing Zhao, Doctor
- Email: zwq7860@163.com
-
Principal Investigator:
- Weiqing Zhao, Doctor
-
Nanjing, Jiangsu, China
- Not yet recruiting
- Nanjing Drum Tower Hospital
-
Contact:
- Huaijun Zhou, Doctor
- Email: zhouhj2007@126.com
-
Principal Investigator:
- Huaijun Zhou, Doctor
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Recruiting
- Fudan University Shanghai Cancer Center
-
Contact:
- Xiaohua Wu, Doctor
- Email: wu.xh@fudan.edu.cn
-
Principal Investigator:
- Xiaohua Wu, Doctor
-
Shanghai, Shanghai, China, 200090
- Not yet recruiting
- Gynecology Hospital of Fudan University
-
Contact:
- Xiaojun Chen, Doctor
- Email: cxjlhjj@163.com
-
Principal Investigator:
- Xiaojun Chen, Doctor
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310016
- Not yet recruiting
- Sir Run Run Shaw Hospital Medical School Zhejiang University
-
Contact:
- Xian Wang, Doctor
- Email: yedw@srrsh.com
-
Principal Investigator:
- Xian Wang, Doctor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TQ-B3525 tablet
|
TQ-B3525 tablet administered orally once a day.
Each cycle is 28 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate (ORR) assessed by Independent Review Committee
Time Frame: up to 48 weeks
|
Percentage of participants achieving complete response (CR) and partial response (PR) based on IRC.
|
up to 48 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate (ORR) assessed by Investigator
Time Frame: up to 48 weeks
|
Percentage of participants achieving complete response (CR) and partial response (PR) assessed by investigator.
|
up to 48 weeks
|
Disease control rate(DCR)
Time Frame: up to 48 weeks
|
Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
|
up to 48 weeks
|
Duration of disease remission (DOR)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TQ-B3525-II-03
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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