A Study to Evaluate the Efficacy and Safety of CYH33 in Patients With Recurrent/Persistent Ovary ā¦ (NCT05043922) | Clinical Trial Compass
Active ā Not RecruitingPhase 2
A Study to Evaluate the Efficacy and Safety of CYH33 in Patients With Recurrent/Persistent Ovary Clear Cell Carcinoma
China93 participantsStarted 2021-10-11
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
ā. Female patients ā„ 18 years of age
ā. Provide informed consent voluntarily.
ā. Patients must have histologically or cytologically confirmed recurrent or persistent ovarian, fallopian tube, or peritoneum clear cell carcinoma.
ā. Patients with recurrent/persistent ovary, fallopian tube or primary peritoneal clear cell carcinoma, who have identified PIK3CA status.
ā. Patients must have failed standard chemotherapy.
ā. ECOG-PS ā¤ 1.
ā. Patient must have adequate organ and bone marrow function measured within 28 days of screening.
Exclusion criteria
ā. Patient has received any anticancer therapy
ā. Patients who had prior treatment with any PI3K, mTOR or AKT inhibitor.
ā. 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.
ā. Any toxicities from prior treatment that have not recovered to baseline.
ā. Patients who have been treated with any hematopoietic colony-stimulating growth factors ā¤ 2 weeks prior to starting study drug.
ā
What they're measuring
1
Tumor ORR in patients with PIK3CA hotspot mutations.
Timeframe: through study completion, an average of 1 year
ā. 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.
ā. 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.