Trials / Unknown
UnknownNCT04836663
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
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TQ-B3525 tablet | TQ-B3525 tablet administered orally once a day. Each cycle is 28 days. |
Timeline
- Start date
- 2021-04-23
- Primary completion
- 2022-09-30
- Completion
- 2022-12-30
- First posted
- 2021-04-08
- Last updated
- 2021-06-01
Locations
5 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04836663. Inclusion in this directory is not an endorsement.