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This is a randomized, open-label, two-period, crossover trial to evaluate the pharmacokinetic profiles of albumin-bound docetaxel for intravenous infusion and Taxotere in patients with advanced solid tumors.
The trial will be performed as a randomized, open-label, two-period crossover trial to compare the test drug (T, albumin-bound docetaxel) to the reference drug (R, Taxotere). Approximately 28 subjects will be randomized to the two treatment sequences (T-R or R-T) at the ratio of 1:1. Each enrolled subject will receive an intravenous infusion of the reference drug and the test drug in two treatment periods per the randomization schedule. The treatment periods will be separated by a washout period of 21 to 35 days. After completing two cycles of treatments, subjects may continue to receive the treatment used in the second cycle according to the responses (up to 1 year).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Albumin-bound docetaxel | Experimental | Subjects will receive albumin-bound docetaxel via intravenous infusion (IV) once every three weeks (a cycle), at the dose of 75mg/m2 |
|
| Taxotere | Experimental | Subjects will receive Taxotere via intravenous infusion once every three weeks (a cycle), at the dose of 75mg/m2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel for Injection (Albumin-bound) | Drug | Docetaxel for Injection (Albumin-bound) by intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| The pharmacokinetic parameters (free docetaxel and total docetaxel) : Cmax | Peak Plasma Concentration (Cmax) | At the end of Cycle 2 (each cycle is 21 days) |
| The pharmacokinetic parameters (free docetaxel and total docetaxel) : AUC0-t、AUC0-∞ | Area under the plasma concentration versus time curve (AUC) | At the end of Cycle 2 (each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 1.The occurrence and frequency of adverse events and serious adverse events | 1. The occurrence and frequency of adverse events and serious adverse events | through study completion, up to 18 weeks |
| 2. 1 Efficacy measures such as overall response rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hui Shan, master | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cangzhou Central Hospital | Cangzhou | China |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D007267 | Injections |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Taxotere | Drug | Taxotere |
|
|
overall response rate (ORR) |
| through study completion, up to 18 weeks |
| 2. 2 Efficacy measures such as progression-free survival (PFS) | progression-free survival (PFS) | through study completion, up to 18 weeks |
| 2.3 Efficacy measures such as disease control rate (DCR) | disease control rate (DCR) | through study completion, up to 18 weeks |
| 2. 4 Efficacy measures such as duration of response (DOR). | duration of response (DOR) | through study completion, up to 18 weeks |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |