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
Not provided
Not provided
Not provided
The purpose of this study is to evaluate safety and the pharmacokinetic characteristics of docetaxel between two docetaxel products in patients with advanced solid cancer.
This is a Phase III study designed to evaluate the pharmacokinetic characteristics of docetaxel between two docetaxel products in patients with advanced solid cancer. This study will also assess the safety of the docetaxel in advanced solid cancer patients.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1st cycle:CKD-810 -> 2nd cycle:Taxotere inj. | Other |
| |
| 1st cycle:Taxotere inj.-> 2nd cycle:CKD-810 | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-810, Taxotere inj. | Drug | Patients will receive docetaxel 75mg/㎡ on Day 1 of each cycle(1 cycle = 3 weeks) as a 1-hour IV infusion. At the 1st cycle, CKD-810 75mg/㎡ administered. If the hematologic or non-hematologic toxicity was not appeared when the 1st cycle intervention was finished, keep going the 2nd cycle intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of CKD-810 and Taxotere inj. | 2 Cycles |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of CKD-810 and Taxotere inj. | 2 Cycles |
Not provided
Inclusion Criteria:
Patient is greater than 18 years of age
Advanced solid tumor
Patient has a life expectancy of at least 3 months
Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
Absolute neutrophil count ≥ 1,500/㎣
Platelet count ≥ 100,000/㎣
Hemoglobin ≥ 9.0g/dL
Total Bilirubin ≤ 1.5 X ULN
Alkaline Phosphatase ≤ 2.5 X ULN
AST/ALT ≤ 2.0 X ULN
Serum creatinine ≤ 1.5 X ULN or Creatinine clearance ≥ 60mL/min(Cockcroft equation)
Patients should voluntarily sign a written informed consent before study entry
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| JH Kang | The Catholic University of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gachon University Gil Hospital | Inchon | South Korea | ||||
| The Catholic university of KOREA, Seoul ST. Mary's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24337589 | Derived | Cho EK, Park JY, Lee KH, Song HS, Min YJ, Kim YH, Kang JH. Open-label, randomized, single-dose, crossover study to evaluate the pharmacokinetics and safety differences between two docetaxel products, CKD-810 and Taxotere injection, in patients with advanced solid cancer. Cancer Chemother Pharmacol. 2014 Jan;73(1):9-16. doi: 10.1007/s00280-013-2264-0. Epub 2013 Dec 12. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| CKD-810, Taxotere inj. | Drug | Patients will receive docetaxel 75mg/㎡ on Day 1 of each cycle(1 cycle = 3 weeks) as a 1-hour IV infusion. At the 1st cycle, Taxotere inj. 75mg/㎡ administered. If the hematologic or non-hematologic toxicity was not appeared when the 1st cycle intervention was finished, keep going the 2nd cycle intervention. |
|
|
| Seoul |
| South Korea |
| The Korea University Anam Hospital | Seoul | South Korea |
| Ajou University Hospital | Suwon | South Korea |
| Dongsan Medical Center, Keimyung University | Taegu | South Korea |
| Yeoungnam University Hospital | Taegu | South Korea |
| Ulsan University Hospital | Ulsan | South Korea |
| ID | Term |
|---|---|
| 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