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| Name | Class |
|---|---|
| Tigermed Consulting Co., Ltd | INDUSTRY |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XY0206-12.5mg | Experimental | Drug:XY0206;Dosage form:Tablet;Dosageļ¼12.5mg;Include single dose treatment and multiple dose phase |
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| XY0206-25mg | Experimental | Drug:XY0206;Dosage form:Tablet;Dosageļ¼25mg;Include single dose treatment and multiple dose phase |
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| XY0206-37.5mg | Experimental | Drug:XY0206;Dosage form:Tablet;Dosageļ¼37.5mg;Include single dose treatment and multiple dose phase |
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| XY0206-50mg | Experimental | Drug:XY0206;Dosage form:Tablet;Dosageļ¼50mg;Include single dose treatment and multiple dose phase |
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| XY0206-75mg | Experimental | Drug:XY0206;Dosage form:Tablet;Dosageļ¼75mg;Include single dose treatment and multiple dose phase |
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| XY0206-100mg | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XY0206 | Drug | Dosage form:Tablet;Single dose treatment:Take the drug once on day 1,each time 1 tablet. Multiple dose phase:Take the medicine once a day,1 tablet at a time.4 weeks of continuous medication is one course of treatment. After the first course of treatment, the subjects can continue to receive the experimental drug treatment until they meet the criteria for stopping treatment or determine the duration and interval of treatment according to the accumulated condition after multiple dose. |
| Measure | Description | Time Frame |
|---|---|---|
| DLT | The occurrence of DLT. | from the start of the medication to the end of the study or 28 days after cessation of medication |
| AE | The occurrence rate of AE. | from the start of the medication to the end of the study or 28 days after cessation of medication |
| ADR | The occurrence rate of adverse drug reactions(ADR). | from the start of the medication to the end of the study or 28 days after cessation of medication |
| SAE | The occurrence rate of SAE. | from the start of the medication to the end of the study or 28 days after cessation of medication |
| Blood routine | One of the laboratory tests. | from the start of the medication to the end of the study or 28 days after cessation of medication |
| Urine routine | One of the laboratory tests. | from the start of the medication to the end of the study or 28 days after cessation of medication |
| Stool routine | One of the laboratory tests. | from the start of the medication to the end of the study or 28 days after cessation of medication |
| Blood biochemistry |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf | area under the concentration-time curve from the time of dosing extrapolated to time infinity. | single dose phase:up to 120 hours;multiple dose phase:up to 24 hours |
| AUC0-24h | area under the concentration-time curve from the time of dosing extrapolated to the 24h after dosing. |
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Inclusion Criteria:
Patients must meet all of the following criteria before entering the group:
Exclusion Criteria:
Patients cannot participate in this clinical study if they meet any of the following conditions:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| wei wang, master | Contact | 086-0311-66703017 | wangwei001@yiling.cn |
| Name | Affiliation | Role |
|---|---|---|
| Binghe Xu, MD | Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College | Recruiting | Beijing | Beijing Municipality | 100021 | China |
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Drug:XY0206;Dosage form:Tablet;Dosageļ¼100mg;Include single dose treatment and multiple dose phase
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One of the laboratory tests. |
| from the start of the medication to the end of the study or 28 days after cessation of medication |
| Coagulation function | One of the laboratory tests. | from the start of the medication to the end of the study or 28 days after cessation of medication |
| 12 lead ecg | One of the laboratory tests. | from the start of the medication to the end of the study or 28 days after cessation of medication |
| Body temperature | One of the vital signs. | from the start of the medication to the end of the study or 28 days after cessation of medication |
| Blood pressure | One of the vital signs. | from the start of the medication to the end of the study or 28 days after cessation of medication |
| Heart rate | One of the vital signs. | from the start of the medication to the end of the study or 28 days after cessation of medication |
| Breathing | One of the vital signs. | from the start of the medication to the end of the study or 28 days after cessation of medication |
| General condition | One of the physical examination. | from the start of the medication to the end of the study or 28 days after cessation of medication |
| Skin | One of the physical examination. | from the start of the medication to the end of the study or 28 days after cessation of medication |
| Head | One of the physical examination. | from the start of the medication to the end of the study or 28 days after cessation of medication |
| Eyes | One of the physical examination. | from the start of the medication to the end of the study or 28 days after cessation of medication |
| Ears | One of the physical examination. | from the start of the medication to the end of the study or 28 days after cessation of medication |
| Nose | One of the physical examination. | from the start of the medication to the end of the study or 28 days after cessation of medication |
| Throat | One of the physical examination. | from the start of the medication to the end of the study or 28 days after cessation of medication |
| Heart | One of the physical examination. | from the start of the medication to the end of the study or 28 days after cessation of medication |
| Lung | One of the physical examination. | from the start of the medication to the end of the study or 28 days after cessation of medication |
| Chest | One of the physical examination. | from the start of the medication to the end of the study or 28 days after cessation of medication |
| Abdomen | One of the physical examination. | from the start of the medication to the end of the study or 28 days after cessation of medication |
| Limbs | One of the physical examination. | from the start of the medication to the end of the study or 28 days after cessation of medication |
| Nerves | One of the physical examination. | from the start of the medication to the end of the study or 28 days after cessation of medication |
| Back/spine | One of the physical examination. | from the start of the medication to the end of the study or 28 days after cessation of medication |
| Lymph nodes | One of the physical examination. | from the start of the medication to the end of the study or 28 days after cessation of medication |
| single dose phase:up to 24 hours;multiple dose phase:up to 24 hours |
| AUC0-72h | area under the concentration-time curve from the time of dosing extrapolated to the 72h after dosing. | single dose phase:up to 72 hours |
| AUC0-120h | area under the concentration-time curve from the time of dosing extrapolated to the 120h after dosing. | single dose phase:up to 120 hours |
| Peak Plasma Concentration (Cmax) | The PK parameters of the plasma sample. | single dose phase:up to 120 hours;multiple dose phase:up to 24 hours |
| CL/F | The PK parameters of the plasma sample. | single dose phase:up to 120 hours;multiple dose phase:up to 24 hours |
| Tmax | The amount of time that a drug is present at the maximum concentration in serum. | single dose phase:up to 120 hours;multiple dose phase:up to 24 hours |
| Cmin,ss | The PK parameters of the plasma sample. | single dose phase:up to 120 hours;multiple dose phase:up to 24 hours |
| Cmax,ss | The PK parameters of the plasma sample. | single dose phase:up to 120 hours;multiple dose phase:up to 24 hours |
| Cav,ss | The PK parameters of the plasma sample. | single dose phase:up to 120 hours;multiple dose phase:up to 24 hours |
| PTF | The PK parameters of the plasma sample. | single dose phase:up to 120 hours;multiple dose phase:up to 24 hours |
| RAUC1 | The PK parameters of the plasma sample. | single dose phase:up to 120 hours;multiple dose phase:up to 24 hours |
| RAUC2 | The PK parameters of the plasma sample. | single dose phase:up to 120 hours;multiple dose phase:up to 24 hours |
| RCmax | The PK parameters of the plasma sample. | single dose phase:up to 120 hours;multiple dose phase:up to 24 hours |
| Kel | The PK parameters of the plasma sample. | single dose phase:up to 120 hours;multiple dose phase:up to 24 hours |
| t1/2 | The PK parameters of the plasma sample. | single dose phase:up to 120 hours;multiple dose phase:up to 24 hours |
| Vz/F | The PK parameters of the plasma sample. | single dose phase:up to 120 hours;multiple dose phase:up to 24 hours |
| AUC_%Extrap | The PK parameters of the plasma sample. | single dose phase:up to 120 hours;multiple dose phase:up to 24 hours |
| Ae0-24h | The PK parameters of the plasma sample. | single dose phase:up to 24 hours;multiple dose phase:up to 24 hours |
| Fe0-24h | The PK parameters of the plasma sample. | single dose phase:up to 24 hours;multiple dose phase:up to 24 hours |
| Ae0-72h | The PK parameters of the plasma sample. | single dose phase:up to 72 hours |
| Fe0-72h | The PK parameters of the plasma sample. | single dose phase:up to 72 hours |
| Ae0-72h stool | The PK parameters of the plasma sample. | single dose phase:up to 72 hours |
| CLr | The PK parameters of the plasma sample. | single dose phase:up to 24 hours;multiple dose phase:up to 24 hours |
| Exploring the relative baseline change percentage of biomarkers (soluble VEGFR2). | The PD parameters of XY0206. | single dose phase:up to 24 hours;multiple dose phase:up to 24 hours |
| Complete response rate (CRR) | Effective parameters of XY0206. | through study completion,such as 30 months. |
| Partial response rate (PRR) | Effective parameters of XY0206. | through study completion,such as 30 months. |
| Objective response rate (ORR) | Effective parameters of XY0206. | through study completion,such as 30 months. |
| Progression-free survival (PFS) | Effective parameters of XY0206. | through study completion,such as 30 months. |
| The First Affiliated Hospital of Hainan Medical College | Not yet recruiting | Haikou | Hainan | 570102 | China |
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| The Fourth Hospital of Hebei Medical University | Not yet recruiting | Shijiazhuang | Hebei | 050000 | China |
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| Tianjin Cancer Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300060 | China |
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