Ovarian Cancer, Recurrent Cancer
Conditions
Keywords
Phase 2 study, Pharmacokinetics
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.
Interventions
DRUGCYH33
a Selective PI3Kα Inhibitor
Sponsors
Haihe Biopharma Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: 1. Female patients ≥ 18 years of age 2. Provide informed consent voluntarily. 3. Patients must have histologically or cytologically confirmed recurrent or persistent ovarian, fallopian tube, or peritoneum clear cell carcinoma. 4. Patients with recurrent/persistent ovary, fallopian tube or primary peritoneal clear cell carcinoma, who have identified PIK3CA status. 5. Patients must have failed standard chemotherapy. 6. ECOG-PS ≤ 1. 7. Patient must have adequate organ and bone marrow function measured within 28 days of screening. Main
Exclusion criteria
Patients are ineligible for this study if they meet any of the following criteria: 1. Patient has received any anticancer therapy 2. Patients who had prior treatment with any PI3K, mTOR or AKT inhibitor. 3. 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. 4. Any toxicities from prior treatment that have not recovered to baseline. 5. Patients who have been treated with any hematopoietic colony-stimulating growth factors ≤ 2 weeks prior to starting study drug. 6. Patients who have symptomatic CNS metastasis. 7. 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. 8. 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. 9. History of acute pancreatitis within 1 year of screening or past medical history of chronic pancreatitis. 10. Patients with clinically significant cardiovascular disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor ORR in patients with PIK3CA hotspot mutations. | 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
| Measure | Time frame | Description |
|---|---|---|
| PFS | through study completion, an average of 1 year | PFS by BIRC using RECIST v1.1 |
| OS | through study completion, an average of 2 year | OS in each of the PIK3CA mutation status cohort |
| genetic and protein biomarker alterations | through study completion, an average of 1 year | genetic and protein biomarker alterations that can impact PI3K signaling pathway |
Countries
China, Japan
Outcome results
None listed