Status:
UNKNOWN
A Study of TQ-B3525 Tablets in Subjects With PIK3CA and/or PIK3R1/2 Gene-altered Recurrent/Metastatic Advanced Gynecologic Tumors
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Advanced Endometrial Cancer, Cervical Cancer and Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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.
- 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.
- Understood and signed an informed consent form.
Exclusion
- 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.
Key Trial Info
Start Date :
April 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2022
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04836663
Start Date
April 23 2021
End Date
December 30 2022
Last Update
June 1 2021
Active Locations (5)
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1
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China, 213003
2
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
3
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
4
Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200090