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| Name | Class |
|---|---|
| 307 Hospital of PLA | OTHER |
| Peking University Cancer Hospital & Institute | OTHER |
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Fluzoparib is an oral potent, selective PARP-1 and PARP-2 inhibitor. The objective of this study will be to investigate the safety and tolerability of Fluzoparib Capsule when given orally to Chinese patients with advanced solid malignancies. In addition, the pharmacokinetic profile, MTD (if possible) and efficacy of Fluzoparib will be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluzoparib | Experimental | Each subject will receive a single dose of fluzoparib on day 1, and then subject will receive fluzoparib twice daily for 28 days during cycle 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzoparib | Drug | Fluzoparib either at 10,20,40,80,120mg ....., capsule oral. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The maximum-tolerated dose (MTD) will be defined as the maximum dose level at which no more than one subject out of three experiences has a dose-limiting toxicity (DLT) upon completing one treatment cycle. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of pharmacokinetic parameter of Fluzoparib: Cmax | 4 weeks | |
| Evaluation of pharmacokinetic parameter of Fluzoparib: Tmax | 4 weeks | |
| Evaluation of pharmacokinetic parameter of Fluzoparib: t1/2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| No.307 Hospital, Academy of Military Medical Sciences | Beijing | Beijing Municipality | 100039 | China | ||
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| C000722917 | fluzoparib |
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| 4 weeks |
| Evaluation of pharmacokinetic parameter of Fluzoparib: AUC | 4 weeks |
| Preliminary antitumor activity for the regimen, objective response rate(ORR) | To evaluate ORR 8 weeks after the initiation of Fluzoparib | 8 weeks |
| Number of participants with adverse events. | Number of Participants with treatment related Adverse Events as Assessed by CTCAE v4.0 | 8 weeks |
| Beijing Cancer Hospital |
| Beijing |
| Beijing Municipality |
| 100142 |
| China |
| 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 |