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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZL-2306 (niraparib) | Experimental | Subjects will be randomised into 100mg, 200mg, 300mg dose group at the first day of the first cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZL-2306 (niraparib) | Drug | About 30 subjects will be enrolled to the study, and randomised into 300mg, 200mg and 100mg dose groups (about 10 subjects per group). All subjects will be randomised into indicated dose group (300mg, 200mg or 100mg) at the first day of the first cycle. A single administration of ZL-2306 (niraparib) will be given to the subjects at indicated dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma drug concentration (Cmax) | From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days) | |
| Time to reach Cmax (Tmax) | From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days) | |
| Terminal rate constant (λz) | From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days) | |
| Elimination half-life (t1/2) | From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days) | |
| Area under the plasma concentration-time curve from time zero to 24hrs (AUC (0-24)) | From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days) | |
| Area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUC(0-t)) and from zero to infinity (AUC0-∞) | From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days) | |
| Apparent total body clearance of the drug from plasma (CL/F) | From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days) | |
| Apparent volume of distribution (Vd/f) | From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days) | |
| Mean residence time (MRT) | From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days) | |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as assessed by CTCAE v4.0 | From the signing of ICF till the end of this study (30 days after the last administration of the study drug or the date to close the clinical trial database, whichever is earlier) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100000 | China | ||
| Sun Yat-sen University Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31439812 | Derived | Zhang J, Zheng H, Gao Y, Lou G, Yin R, Ji D, Li W, Wang W, Xia B, Wang D, Hou J, Yan J, Hei Y, Zhang ZY, Milton A, Wu X. Phase I Pharmacokinetic Study of Niraparib in Chinese Patients with Epithelial Ovarian Cancer. Oncologist. 2020 Jan;25(1):19-e10. doi: 10.1634/theoncologist.2019-0565. Epub 2019 Aug 22. |
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|
| Degree of fluctuation (DF) |
| From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days) |
| Maximum plasma drug concentration at steady-state (Css max) | From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days) |
| Time to reach Css max (Tss max) | From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days) |
| Minimum plasma drug concentration at steady-state (Css min) | From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days) |
| Area under the plasma concentration-time curve from time zero to the end of drug administration (AUCss) | From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days) |
| Steady-state apparent total body clearance of drug from plasma (Clss/F) | From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days) |
| Accumulation ratio following multiple drug administration (RAC) | From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days) |
| The plasma drug concentration before drug administration | From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days) |
| Guangzhou |
| Guangdong |
| 510000 |
| China |
| Haerbin Medical University Cancer Hospital | Harbin | Heilongjiang | 150000 | China |
| Hunan Cancer Hospital | Changsha | Hunan | 410013 | China |
| Fudan University Shanghai Cnacer Center | Shanghai | Shanghai Municipality | 200000 | China |
| The West China Second UniversityHospital of Sichuan University | Chengdu | Sichuan | 610000 | China |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| 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 |
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| ID | Term |
|---|---|
| C545685 | niraparib |
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