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A Study of TQ-B3525 Tablets in Subjects With PIK3CA and/or PIK3R1/2 Gene-altered Recurrent/Metastatic Advanced Gynecologic Tumors

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ClinicalTrials.gov Identifier: NCT04836663
Recruitment Status : Recruiting
First Posted : April 8, 2021
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Brief Summary:
This is a study to evaluate the efficacy and safety of TQ-B3525 in subjects with recurrent / metastatic advanced endometrial cancer, cervical cancer and ovarian cancer with PIK3CA and / or PIK3R1 / 2 gene-altered (mutation or amplification). Endometrial cancer, cervical cancer and ovarian cancer are divided into three cohorts, each cohort administrated TQ-B3525 tablet orally once a day.

Condition or disease Intervention/treatment Phase
Advanced Endometrial Cancer, Cervical Cancer and Ovarian Cancer Drug: TQ-B3525 tablet Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: TQ-B3525 tablet Drug: TQ-B3525 tablet
TQ-B3525 tablet administered orally once a day. Each cycle is 28 days.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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).

  4. 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.

  5. 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.

  6. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

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


Locations
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China, Jiangsu
The First People's Hospital of Changzhou Not yet recruiting
Changzhou, Jiangsu, China, 213003
Contact: Weiqing Zhao, Doctor       zwq7860@163.com   
Principal Investigator: Weiqing Zhao, Doctor         
Nanjing Drum Tower Hospital Not yet recruiting
Nanjing, Jiangsu, China
Contact: Huaijun Zhou, Doctor       zhouhj2007@126.com   
Principal Investigator: Huaijun Zhou, Doctor         
China, Shanghai
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China, 200032
Contact: Xiaohua Wu, Doctor       wu.xh@fudan.edu.cn   
Principal Investigator: Xiaohua Wu, Doctor         
Gynecology Hospital of Fudan University Not yet recruiting
Shanghai, Shanghai, China, 200090
Contact: Xiaojun Chen, Doctor       cxjlhjj@163.com   
Principal Investigator: Xiaojun Chen, Doctor         
China, Zhejiang
Sir Run Run Shaw Hospital Medical School Zhejiang University Not yet recruiting
Hangzhou, Zhejiang, China, 310016
Contact: Xian Wang, Doctor       yedw@srrsh.com   
Principal Investigator: Xian Wang, Doctor         
Sponsors and Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
ClinicalTrials.gov Identifier: NCT04836663    
Other Study ID Numbers: TQ-B3525-II-03
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometrial Neoplasms
Genital Neoplasms, Female
Neoplasms by Site
Neoplasms
Urogenital Neoplasms
Uterine Neoplasms
Uterine Diseases