Back to resultsA Study of TQ-B3525 Tablets in Subjects With PIK3CA and/or PIK3R1/2 Gene-altered Recurrent/Metastatic Advanced Gynecologic Tumors
Primary Purpose
Advanced Endometrial Cancer, Cervical Cancer and Ovarian Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
TQ-B3525 tablet
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Endometrial Cancer, Cervical Cancer and Ovarian Cancer
Eligibility 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.
Sites / Locations
- The First People's Hospital of Changzhou
- Nanjing Drum Tower Hospital
- Fudan University Shanghai Cancer CenterRecruiting
- Gynecology Hospital of Fudan University
- Sir Run Run Shaw Hospital Medical School Zhejiang University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TQ-B3525 tablet
Arm Description
Outcomes
Primary Outcome Measures
Overall response rate (ORR) assessed by Independent Review Committee
Percentage of participants achieving complete response (CR) and partial response (PR) based on IRC.
Secondary Outcome Measures
Overall response rate (ORR) assessed by Investigator
Percentage of participants achieving complete response (CR) and partial response (PR) assessed by investigator.
Disease control rate（DCR）
Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
Duration of disease remission (DOR)
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)
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)
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)
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.
Full Information
NCT ID
NCT04836663
First Posted
April 6, 2021
Last Updated
May 27, 2021
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04836663
Brief Title
A Study of TQ-B3525 Tablets in Subjects With PIK3CA and/or PIK3R1/2 Gene-altered Recurrent/Metastatic Advanced Gynecologic Tumors
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 23, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Endometrial Cancer, Cervical Cancer and Ovarian Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TQ-B3525 tablet
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
TQ-B3525 tablet
Intervention Description
TQ-B3525 tablet administered orally once a day. Each cycle is 28 days.
Primary Outcome Measure Information:
Title
Overall response rate (ORR) assessed by Independent Review Committee
Description
Percentage of participants achieving complete response (CR) and partial response (PR) based on IRC.
Time Frame
up to 48 weeks
Secondary Outcome Measure Information:
Title
Overall response rate (ORR) assessed by Investigator
Description
Percentage of participants achieving complete response (CR) and partial response (PR) assessed by investigator.
Time Frame
up to 48 weeks
Title
Disease control rate（DCR）
Description
Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
Time Frame
up to 48 weeks
Title
Duration of disease remission (DOR)
Description
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).
Time Frame
up to 48 weeks
Title
Progression-free survival (PFS)
Description
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.
Time Frame
up to 48 weeks
Title
Overall survival (OS)
Description
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.
Time Frame
up to 72 weeks
Title
DOR rate (≥ 6 months) (percentage of subjects with disease remission duration ≥ 6 months)
Description
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.
Time Frame
up to 48 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
The First People's Hospital of Changzhou
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213003
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weiqing Zhao, Doctor
Email
zwq7860@163.com
First Name & Middle Initial & Last Name & Degree
Weiqing Zhao, Doctor
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huaijun Zhou, Doctor
Email
zhouhj2007@126.com
First Name & Middle Initial & Last Name & Degree
Huaijun Zhou, Doctor
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaohua Wu, Doctor
Email
wu.xh@fudan.edu.cn
First Name & Middle Initial & Last Name & Degree
Xiaohua Wu, Doctor
Facility Name
Gynecology Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200090
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaojun Chen, Doctor
Email
cxjlhjj@163.com
First Name & Middle Initial & Last Name & Degree
Xiaojun Chen, Doctor
Facility Name
Sir Run Run Shaw Hospital Medical School Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xian Wang, Doctor
Email
yedw@srrsh.com
First Name & Middle Initial & Last Name & Degree
Xian Wang, Doctor
12. IPD Sharing Statement
Learn more about this trial
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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