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This trial is an open-label, single-center, dose-escalation and cohort-expansion Phase I clinical study in patients with advanced solid tumors. The aim of this study is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of albumin-bound formulation of docetaxel for intravenous infusion in patients with advanced solid tumors.
This study was conducted in two stages. The first stage (Stage I) is a dose-escalation study. A classic 3+3 design will be used to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D). Patients with advanced solid tumors will be assigned to receive sequentially higher doses of albumin-bound formulation of docetaxel once every three weeks (a Cycle) by intravenous infusion, starting at a dose of 50mg/m2. Patients will receive the albumin-bound formulation of docetaxel
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: solid tumors | Experimental | Albumin-bound docetaxel by intravenous infusion.Patients receive albumin-bound docetaxel once every three weeks (a Cycle), starting at a dose of 50mg/m2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albumin-bound docetaxel | Drug | Albumin-bound docetaxel by intravenous infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who experienced AE during cycle1. | AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol specified procedure, whether or not considered related to the medicinal product/protocol specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. | 21 days. |
| Number of participants who experienced DLT during cycle1. | A DLT was graded using the National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.02 and defined as any of the following: grade 3 or 4 non-hematologic adverse events unless they were not optimally treated with supportive care; grade 3 or 4 asymptomatic laboratory abnormal values lasting >7 days; prolonged grade 2 toxicity (lasting more than 2 weeks) leading to treatment interruption and/or dose reduction; pancytopenia with a hypocellular bone marrow and no marrow blasts lasting ≥6 weeks (AL participants); grade 3 neutropenia with fever or infection (OHM participants); grade 3 thrombocytopenia with bleeding (OHM participants); or grade 4 neutropenia or thrombocytopenia, regardless of symptoms and lasting ≥3 days (OHM participants). | 21 days. |
| Classic 3+3 design to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) | The maximum tolerated dose (MTD) (if available) and recommended Phase 2 dose (RP2D) of Albumin-bound Docetaxel. | Through study completion, an average of 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of Albumin-bound Docetaxel from time 0 to last (AUC 0-∞) | The pharmacokinetic parameters AUC0-last of Albumin-bound Docetaxel. | 21 days. |
| Area under the concentration-time curve of Albumin-bound Docetaxel from time 0 to infinity (AUC 0-∞) |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers of Albumin-bound Docetaxel. | The correlation between the AAG level(in plasma) and albumin-bound docetaxel. | 21 days. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bi Feng, Chief doctor | Contact | 028-85423203 | bifenggcp@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | China |
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The pharmacokinetic parameters AUC0-∞ of Albumin-bound Docetaxel. |
| 21 days. |
| Observed maximum concentration (Cmax )of Albumin-bound Docetaxel | The pharmacokinetic parameters Cmax of Albumin-bound Docetaxel. | 21 days. |
| Time to maximum concentration (Tmax) of Albumin-bound Docetaxel | The pharmacokinetic parameters Tmax of Albumin-bound Docetaxel. | 21 days. |
| Apparent terminal Half-Life (t1/2) of Albumin-bound Docetaxel | The pharmacokinetic parameters t½ of Albumin-bound Docetaxel. | 21 days. |
| Apparent total body clearance (CL/F) of Albumin-bound Docetaxel | The pharmacokinetic parameters CL/F of Albumin-bound Docetaxel. | 21 days. |
| Objective response rate (ORR) | Efficacy measures overall response rate (ORR) of Albumin-bound Docetaxel. | Through study completion, an average of 1 year. |
| Progression free survival (PFS) | Efficacy measures progression-free survival (PFS) of Albumin-bound Docetaxel. | Through study completion, an average of 1 year. |
| Disease control rate (DCR) | Efficacy measures disease control rate (DCR) of Albumin-bound Docetaxel. | Through study completion, an average of 1 year. |
| Duration of response (DOR) | Efficacy measures duration of response (DOR) of Albumin-bound Docetaxel. | Through study completion, an average of 1 year. |