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
| Name | Class |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | INDUSTRY |
The purpose of this study is to confirm the safety of Apatinib at a dose level up to 750 mg/d with standard therapy of docetaxel (60 mg/m²) in advanced lung adenocarcinoma patients harboring wild-type EGFR after failure of first line chemotherapy and to determine the recommended dose for the Phase II trial.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apatinib + Docetaxel | Experimental | Low, medium or high dose of Apatinib (days 3-19, q3w) and Docetaxel (60 mg/m2, day 1, q3w) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib (250 mg/d) + Docetaxel (60 mg/m2) | Drug |
| ||
| Apatinib (500 mg/d) + Docetaxel (60 mg/m2) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (MTD) of Apatinib in combination with Docetaxel (60 mg/m2) | During the first treatment course, up to 3 weeks | |
| Number of Participants Experienced Dose Limited Toxicity (DLT) in Combination Therapy of Apatinib and Docetaxel | During the first treatment course, up to 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 for All Courses | Between the first administration of Docetaxel and 28 days after last administration of Apatinib, up to 1 year | |
| Objective Response Rate (ORR) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Wang, MD, PhD | Contact | +86 13910704669 | jiewang_hr@sina.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| Apatinib (750 mg/d) + Docetaxel (60 mg/m2) | Drug |
|
| Every 6 weeks from the first treatment course, up to 1 year |
| Progression-free Survival (PFS) | Every 6 weeks from the first treatment course, up to 2 year |
| ID | Term |
|---|---|
| D000077192 | Adenocarcinoma of Lung |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| C553458 | apatinib |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided