NCT05043922
Active, not recruiting
Phase 2
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
Haihe Biopharma Co., Ltd.36 sites in 2 countries93 target enrollmentStarted: October 11, 2021Last updated:
Overview
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Haihe Biopharma Co., Ltd.
- Enrollment
- 93
- Locations
- 36
- Primary Endpoint
- Tumor ORR in patients with PIK3CA hotspot mutations.
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Main Inclusion Criteria:
- •Female patients ≥ 18 years of age
- •Provide informed consent voluntarily.
- •Patients must have histologically or cytologically confirmed recurrent or persistent ovarian, fallopian tube, or peritoneum clear cell carcinoma.
- •Patients with recurrent/persistent ovary, fallopian tube or primary peritoneal clear cell carcinoma, who have identified PIK3CA status.
- •Patients must have failed standard chemotherapy.
- •Patient must have adequate organ and bone marrow function measured within 28 days of screening.
Exclusion Criteria
- •Patients are ineligible for this study if they meet any of the following criteria:
- •Patient has received any anticancer therapy
- •Patients who had prior treatment with any PI3K, mTOR or AKT inhibitor.
- •Radical radiation therapy within 4 weeks prior to the first dose of the investigational product or received local palliative radiation therapy for bone metastases within 2 weeks.
- •Any toxicities from prior treatment that have not recovered to baseline.
- •Patients who have been treated with any hematopoietic colony-stimulating growth factors ≤ 2 weeks prior to starting study drug.
- •Patients who have symptomatic CNS metastasis.
- •Major surgery or had significant traumatic injury within 28 days prior to the first dose of the investigational product or has not recovered from major side effects.
- •Known HIV infection with a history of acquired immunodeficiency syndrome (AIDS)-defining opportunity infection within the past 12 months; active hepatitis B and hepatitis C.
- •History of acute pancreatitis within 1 year of screening or past medical history of chronic pancreatitis.
Arms & Interventions
CYH33
Experimental
40mg daily
Intervention: CYH33 (Drug)
Outcomes
Primary Outcomes
Tumor ORR in patients with PIK3CA hotspot mutations.
Time Frame: through study completion, an average of 1 year
Tumor ORR per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 in patients with PIK3CA hotspot mutations.
Secondary Outcomes
- OS(through study completion, an average of 2 year)
- genetic and protein biomarker alterations(through study completion, an average of 1 year)
- PFS(through study completion, an average of 1 year)
Investigators
Study Sites (36)
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