Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study of Tolerance and Pharmacokinetics of TQ-B3233 Capsule, phase I,single arm.
The maximum tolerated dose (MTD) of TQ-B3233 [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]The highest dose at which no more than 33% of the subjects experience a dose-limiting toxicity (DLT) during treatment.
Pharmacokinetics of TQ-B3233 (in whole blood):In the study of single-dose, full PK profiles will be obtained at H0/H0.5/H1/H2/H3/H5/H8/H10/H12/H24/H48/H72(H means Hour).In the study of multiple-dose,full PK profiles will be obtained at D0/D1/D2/D8/D15/D22/D28(D means Day).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQ-B3233 capsule | Experimental | QD or BID; patients are given the doses according to the protocal, and a cycle is 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQ-B3233 | Drug | QD or BID in different stage of this research |
|
| Measure | Description | Time Frame |
|---|---|---|
| maximum tolerated dose(MTD) | 28 Days | |
| dose-limiting toxicity(DLT) | 28 Days | |
| Peak Plasma Concentration(Cmax) | up to 28 Days | |
| Peak time(Tmax) | up to 28 Days | |
| Half life(t1/2) | up to 28 Days | |
| Area under the plasma concentration versus time curve (AUC) | up to 28 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | up to 24 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guo Jun, doctor | Contact | 010-88196317 | guoj307@126.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing cancer hospital | Recruiting | Beijing | 100142 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided