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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CYH33 | Experimental | 40mg daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CYH33 | Drug | a Selective PI3Kα Inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor ORR in patients with PIK3CA hotspot mutations. | Tumor ORR per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 in patients with PIK3CA hotspot mutations. | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | PFS by BIRC using RECIST v1.1 | through study completion, an average of 1 year |
| OS | OS in each of the PIK3CA mutation status cohort |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | type, incidence, duration, severity and seriousness of adverse events (AEs) | through study completion, an average of 1 year |
| DLT (Dose Limiting Toxicity) in Japanese patients | Number and proportion of patients who experienced DLT during the first 28-day of treatment in Japanese patients in safety run-in study. |
Main Inclusion Criteria:
Main Exclusion Criteria:
Patients are ineligible for this study if they meet any of the following criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Obstetrics and Gynecology Hospital, Capital Medical University | Beijing | China | ||||
| Chinese PLA General Hospital |
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| through study completion, an average of 2 year |
| genetic and protein biomarker alterations | genetic and protein biomarker alterations that can impact PI3K signaling pathway | through study completion, an average of 1 year |
| 4 weeks |
| Peak Plasma Concentration (Cmax) | Pharmacokinetics parameters | 4weeks |
| Area under the plasma concentration versus time curve (AUC) | Pharmacokinetics parameters | 4weeks |
| Beijing |
| China |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | China |
| The Southwest Hospital of AMU | Chongqing | China |
| Sun Yat-sen University Cancer Center | Guangdong | China |
| The First Affiliated Hospital, Sun Yat-sen University | Guangdong | China |
| The First Affiliated Hospital of Hainan Medical College | Haikou | China |
| The Third People's Hospital of Hainan Province | Hainan | China |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | China |
| Zhejiang Cancer Hospital | Hangzhou | China |
| Harbin Medical University Cancer Hospital | Harbin | China |
| Hubei Cancer Hospital | Hubei | China |
| Hunan Cancer Hospital | Hunan | China |
| Qilu Hospital of Shandong University | Jinan | China |
| Jiangsu Province Hospital | Nanjing | China |
| The People's Hospital Of Guangxi Zhuang Autonomous Region | Nanning | China |
| Qingdao Central Hospital | Qingdao | China |
| Obstetrics & Gynecology Hospital of Fudan University | Shanghai | China |
| Shanghai First Maternity and Infant Hospital | Shanghai | China |
| Xiaohua wu | Shanghai | China |
| West China Second University Hospital, Sichuan University | Sichuan | China |
| Tianjin Medical University General Hospital | Tianjin | China |
| Zhongnan Hospital of Wuhan University | Wuhan | China |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | China |
| Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University | Zhejiang | China |
| Kurume University Hospital | Kurume | Fukuoka | Japan |
| Osaka University Hospital | Suita | Osaka | Japan |
| National Cancer Center Hospital | Chuo Ku | Tokyo | Japan |
| Jikei University Hospital | Minato-Ku | Tokyo | Japan |
| Keio University Hospital | Shinjuku-Ku | Tokyo | Japan |
| Shikoku Cancer Center | Matsuyama | Japan |
| Nagoya University Hospital | Nagoya | Japan |
| Niigata University Medical & Dental Hospital | Niigata | Japan |
| Okayama University Hospital | Okayama | Japan |
| Hokkaido University Hospital | Sapporo | Japan |
| Tohoku University Hospital | Sendai | Japan |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000634149 | CYH33 |
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