Spots Global Cancer Trial Database for The Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of ZL-2306 (Niraparib) in Patients With Ovarian Cancer
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Trial Identification
Brief Title: The Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of ZL-2306 (Niraparib) in Patients With Ovarian Cancer
Official Title: An Open-Label,Single-Arm,Phase I Clinical Trial to Evaluate the Pharmacokinetics,Safety and Tolerability of ZL-2306 (Niraparib) in Patients With Ovarian Cancer,Fallopian Tube Cancer and Primary Peritoneal Cancer (Collectively Termed as Ovarian Cancer)
Study ID: NCT03551171
Conditions
Interventions
Study Description
Brief Summary: Niraparib is a potent and highly selective PARP-1/-2 inhibitor. The primary objective of this trial is to evaluate the pharmacokinetic (PK) properties of ZL-2306 (niraparib) and its metabolite M1 in patients from Mainland China with ovarian cancer, following a single and multiple oral administration of the study drug at the indicated dose (300mg, 200mg or 100mg), once a day.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Beijing Cancer Hospital, Beijing, Beijing, China
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
Haerbin Medical University Cancer Hospital, Harbin, Heilongjiang, China
Hunan Cancer Hospital, Changsha, Hunan, China
Fudan University Shanghai Cnacer Center, Shanghai, Shanghai, China
The West China Second UniversityHospital of Sichuan University, Chengdu, Sichuan, China
Contact Details
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