Clinical trial NCT05043922: A Study to Evaluate the Efficacy and Safety of CYH33 in Patients With Recurrent/Persistent Ovary Clear Cell Carcinoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ovarian Cancer
Recurrent Cancer
Keywords: Phase 2 study
Pharmacokinetics
Lead sponsor: Haihe Biopharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-09-14
Enrollment: 86
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Tumor ORR in patients with PIK3CA hotspot mutations.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: PFS
timeFrame: through study completion, an average of 1 year
measure: OS
timeFrame: through study completion, an average of 2 year
measure: genetic and protein biomarker alterations
timeFrame: through study completion, an average of 1 year
Other outcomes:
measure: Safety and tolerability
timeFrame: through study completion, an average of 1 year
measure: DLT (Dose Limiting Toxicity) in Japanese patients
timeFrame: 4 weeks
measure: Peak Plasma Concentration (Cmax)
timeFrame: 4weeks
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: 4weeks
Locations:
city: Beijing
country: China
facility: Beijing Obstetrics and Gynecology Hospital, Capital Medical University
city: Beijing
country: China
facility: Chinese PLA General Hospital
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
city: Chongqing
country: China
facility: The Southwest Hospital of AMU
city: Guangdong
country: China
facility: Sun Yat-sen University Cancer Center
city: Guangdong
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
city: Haikou
country: China
facility: The First Affiliated Hospital of Hainan Medical College
city: Hainan
country: China
facility: The Third People's Hospital of Hainan Province
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Hubei
country: China
facility: Hubei Cancer Hospital
city: Hunan
country: China
facility: Hunan Cancer Hospital
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
city: Nanjing
country: China
facility: Jiangsu Province Hospital
city: Nanning
country: China
facility: The People's Hospital Of Guangxi Zhuang Autonomous Region
city: Qingdao
country: China
facility: Qingdao Central Hospital
city: Shanghai
country: China
facility: Obstetrics & Gynecology Hospital of Fudan University
city: Shanghai
country: China
facility: Shanghai First Maternity and Infant Hospital
city: Shanghai
country: China
facility: Xiaohua wu
city: Sichuan
country: China
facility: West China Second University Hospital, Sichuan University
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
city: Zhejiang
country: China
facility: Sir Run Run Shaw Hospital， School of Medicine, Zhejiang University
city: Kurume
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Suita
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Chuo Ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Minato-Ku
country: Japan
facility: Jikei University Hospital
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Matsuyama
country: Japan
facility: Shikoku Cancer Center
city: Nagoya
country: Japan
facility: Nagoya University Hospital
city: Niigata
country: Japan
facility: Niigata University Medical & Dental Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
city: Sendai
country: Japan
facility: Tohoku University Hospital
Study officials:
References: