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This is a Phase 1, open-label, dose-escalation ,and multidose study, aiming to investigate the safety, tolerability and pharmacokinetics of Gimatecan in Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer. To explore the dose-limiting toxicity (DLT) and the maximum tolerable dose (MTD) of oral administration of Gimatecan capsules 5 consecutive days, every 28 days.
The clinical trial is used the traditional 3 +3 design and conducted in two dose groups, 0.6mg/m2/d and 0.8mg/m2/d, with an improved dose escalation design. The initial dose is 0.6mg/m2, once a day for 5 consecutive days, every 28 days for a course of treatment. Subjects are assigned to the corresponding dose group according to the order of enrolling. DLT is observed within 28 days of the first dose of Gimatecan. In the absence of DLT as prescribed by the protocol, the next dose group is started until the maximum tolerated dose (MTD) is observed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gimatecan 0.6mg/m2/d | Experimental | Three or six patients will be treated with the dose of 0.6mg/m2/d for once a day for 5 consecutive days of Gimatecan. DLT will be observed within 28 days after administration. |
|
| Gimatecan 0.8mg/m2/d | Experimental | Three or six patients will be treated with the dose of 0.8mg/m2/d for once a day for 5 consecutive days of Gimatecan. DLT will be observed within 28 days after administration. |
|
| Gimatecan 0.4mg/m2/d | Experimental | Three or six patients will be treated with the dose of 0.4mg/m2/d for once a day for 5 consecutive days of Gimatecan. DLT will be observed within 28 days after administration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gimatecan 0.6mg/m2/d | Drug | 0.6mg/m2/d for once a day for 5 consecutive days of Gimatecan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicity(DLT) | Adverse events of level 3 or above related to the study drug occurring within 28 days after the first dose as assessed by CTCAE v5.0. | 28 days after first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal tolerable dose(MTD) | DLT occurs in less than 1/6 subjects, this lower dose is defined as MTD. | 28 days after first dose |
| Measure | Description | Time Frame |
|---|---|---|
| The overall response rate(ORR) | The proportion of subjects who achieve the optimal objective response rate(PR or CR). | through study completion, an average of 2 years |
| AUC(0-t) | Area under curve 0-t |
Inclusion Criteria:
Exclusion Criteria:
female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hong Zheng, MD | Contact | 13641356816 | Zhhong306@Hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hong Zheng, MD | Beijing Tumor Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tumor Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| 0.8mg/m2/d | Drug | 0.8mg/m2/d for once a day for 5 consecutive days of Gimatecan |
|
| 0.4mg/m2/d | Drug | 0.4mg/m2/d for once a day for 5 consecutive days of Gimatecan |
|
| 28 days after first dose |
| Cmax | Peak concentration | 28 days after first dose |
| Tmax | Peak concentration | 28 days after first dose |
| T1/2 | Half life | 28 days after first dose |
| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| 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 |
| D005184 | Fallopian Tube Diseases |
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| ID | Term |
|---|---|
| C433984 | ST 1481 |
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