Trials / Active Not Recruiting
Active Not RecruitingNCT05043922
A Study to Evaluate the Efficacy and Safety of CYH33 in Patients With Recurrent/Persistent Ovary Clear Cell Carcinoma
A Phase II, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of CYH33, a Selective PI3Kα Inhibitor in Patients With Recurrent/Persistent Ovary, Fallopian Tube or Primary Peritoneal Clear Cell Carcinoma
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 93 (actual)
- Sponsor
- Haihe Biopharma Co., Ltd. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the treatment efficacy of CYH33 monotherapy in patients with recurrent or persistent ovarian, fallopian tube or primary peritoneal clear cell carcinoma harboring PIK3CA hotspot mutation, who received prior systemic anti-tumor treatment.
Detailed description
The purpose of this study is to determine whether treatment with single agent CYH33 significantly improves ORR compared to historical efficacy data in patients with recurrent/persistent ovarian clear cell carcinoma (OCCC) harboring PIK3CA hotspot mutations who received prior systemic anti-tumor treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CYH33 | a Selective PI3Kα Inhibitor |
Timeline
- Start date
- 2021-10-11
- Primary completion
- 2024-07-31
- Completion
- 2026-02-28
- First posted
- 2021-09-14
- Last updated
- 2026-01-30
Locations
36 sites across 2 countries: China, Japan
Source: ClinicalTrials.gov record NCT05043922. Inclusion in this directory is not an endorsement.