Phase
Condition
Ovarian Cancer
Pelvic Cancer
Vaginal Cancer
Treatment
N/AClinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Main Inclusion Criteria:
- Female patients ≥ 18 years of age
- Provide informed consent voluntarily.
- Patients must have histologically or cytologically confirmed recurrent or persistentovarian, fallopian tube, or peritoneum clear cell carcinoma.
- Patients with recurrent/persistent ovary, fallopian tube or primary peritoneal clearcell carcinoma, who have identified PIK3CA status.
- Patients must have failed standard chemotherapy.
- ECOG-PS ≤ 1.
- Patient must have adequate organ and bone marrow function measured within 28 days ofscreening.
Exclusion
Main 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 theinvestigational product or received local palliative radiation therapy for bonemetastases within 2 weeks.
- Any toxicities from prior treatment that have not recovered to baseline.
- Patients who have been treated with any hematopoietic colony-stimulating growthfactors ≤ 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 firstdose 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 Band hepatitis C.
- History of acute pancreatitis within 1 year of screening or past medical history ofchronic pancreatitis.
- Patients with clinically significant cardiovascular disease
Study Design
Study Description
Connect with a study center
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Beijing,
ChinaActive - Recruiting
Chinese PLA General Hospital
Beijing,
ChinaActive - Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing,
ChinaActive - Recruiting
The Southwest Hospital of AMU
Chongqing,
ChinaActive - Recruiting
Sun Yat-sen University Cancer Center
Guangdong,
ChinaActive - Recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangdong,
ChinaActive - Recruiting
The First Affiliated Hospital of Hainan Medical College
Haikou,
ChinaActive - Recruiting
The Third People's Hospital of Hainan Province
Hainan,
ChinaActive - Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou,
ChinaActive - Recruiting
Zhejiang Cancer Hospital
Hangzhou,
ChinaActive - Recruiting
Harbin Medical University Cancer Hospital
Harbin,
ChinaActive - Recruiting
Hubei Cancer Hospital
Hubei,
ChinaActive - Recruiting
Hunan Cancer Hospital
Hunan,
ChinaActive - Recruiting
Qilu Hospital of Shandong University
Jinan,
ChinaActive - Recruiting
Jiangsu Province Hospital
Nanjing,
ChinaActive - Recruiting
The People's Hospital Of Guangxi Zhuang Autonomous Region
Nanning,
ChinaActive - Recruiting
Qingdao Central Hospital
Qingdao,
ChinaActive - Recruiting
Obstetrics & Gynecology Hospital of Fudan University
Shanghai,
ChinaActive - Recruiting
Shanghai First Maternity and Infant Hospital
Shanghai,
ChinaActive - Recruiting
Xiaohua wu
Shanghai,
ChinaActive - Recruiting
West China Second University Hospital, Sichuan University
Sichuan,
ChinaActive - Recruiting
Tianjin Medical University General Hospital
Tianjin,
ChinaActive - Recruiting
Zhongnan Hospital of Wuhan University
Wuhan,
ChinaActive - Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an,
ChinaActive - Recruiting
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Zhejiang,
ChinaActive - Recruiting
Kurume University Hospital
Kurume, Fukuoka
JapanActive - Recruiting
Osaka University Hospital
Suita, Osaka
JapanSite Not Available
National Cancer Center Hospital
Chuo Ku, Tokyo
JapanActive - Recruiting
Jikei University Hospital
Minato-Ku, Tokyo
JapanSite Not Available
Keio University Hospital
Shinjuku-Ku, Tokyo
JapanActive - Recruiting
Shikoku Cancer Center
Matsuyama,
JapanSite Not Available
Nagoya University Hospital
Nagoya,
JapanActive - Recruiting
Niigata University Medical & Dental Hospital
Niigata,
JapanSite Not Available
Okayama University Hospital
Okayama,
JapanActive - Recruiting
Hokkaido University Hospital
Sapporo,
JapanActive - Recruiting
Tohoku University Hospital
Sendai,
JapanActive - Recruiting
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