A Study of TQ-B3525 Tablets in Subjects With PIK3CA and/or PIK3R1/2 Gene-altered Recurrent/Metastatic Advanced Gynecologic Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04836663|
Recruitment Status : Recruiting
First Posted : April 8, 2021
Last Update Posted : April 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Advanced Endometrial Cancer, Cervical Cancer and Ovarian Cancer||Drug: TQ-B3525 tablet||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Estimated Study Start Date :||April 2021|
|Estimated Primary Completion Date :||September 30, 2022|
|Estimated Study Completion Date :||December 30, 2022|
|Experimental: TQ-B3525 tablet||
Drug: TQ-B3525 tablet
TQ-B3525 tablet administered orally once a day. Each cycle is 28 days.
- 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.
- 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.
- 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).
- 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).
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04836663
|The First People's Hospital of Changzhou||Not yet recruiting|
|Changzhou, Jiangsu, China, 213003|
|Contact: Weiqing Zhao, Doctor email@example.com|
|Principal Investigator: Weiqing Zhao, Doctor|
|Nanjing Drum Tower Hospital||Not yet recruiting|
|Nanjing, Jiangsu, China|
|Contact: Huaijun Zhou, Doctor firstname.lastname@example.org|
|Principal Investigator: Huaijun Zhou, Doctor|
|Fudan University Shanghai Cancer Center||Recruiting|
|Shanghai, Shanghai, China, 200032|
|Contact: Xiaohua Wu, Doctor email@example.com|
|Principal Investigator: Xiaohua Wu, Doctor|
|Gynecology Hospital of Fudan University||Not yet recruiting|
|Shanghai, Shanghai, China, 200090|
|Contact: Xiaojun Chen, Doctor firstname.lastname@example.org|
|Principal Investigator: Xiaojun Chen, Doctor|
|Sir Run Run Shaw Hospital Medical School Zhejiang University||Not yet recruiting|
|Hangzhou, Zhejiang, China, 310016|
|Contact: Xian Wang, Doctor email@example.com|
|Principal Investigator: Xian Wang, Doctor|