Official Title: “Open Label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetics of Docetaxel Between Two Docetaxel Products, CKD-810 and Taxotere Inj., in Patients With Advanced Solid Cancer”

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.

Study Type: Interventional

Study Design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Study Primary Completion Date: June 2011

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.

Intervention(s) in this Clinical Trial

• Drug: CKD-810, Taxotere inj.
  • 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.
• Drug: CKD-810, Taxotere inj.
  • 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.

Arms, Groups and Cohorts in this Clinical Trial

• Other: 1st cycle:CKD-810 -> 2nd cycle:Taxotere inj.
• Other: 1st cycle:Taxotere inj.-> 2nd cycle:CKD-810

Primary Measures

• Pharmacokinetics of CKD-810 and Taxotere inj.
  • Time Frame: 2 Cycles
    Safety Issue?: No

Secondary Measures

• Safety of CKD-810 and Taxotere inj.
  • Time Frame: 2 Cycles
    Safety Issue?: No

Inclusion Criteria:

• Patient is greater than 18 years of age
• Advanced solid tumor
• locally advanced or metastatic breast cancer which docetaxel alone therapy was adequate
• locally advanced or metastatic non-small cell lung cancer which docetaxel alone therapy was adequate
• locally advanced or metastatic other malignant tumor which docetaxel alone therapy was adequate
• 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:

• If present, any active bacterial infection that have to parenteral antibiotic therapy. Patients may be included if their infection has resolved to totally or controlled state
• Brain metastasis with neurologic symptom
• History of unstable cardiac arrhythmia, congestive heart failure or myocardial infarction within 6 months
• Known to test positive for HIV or hepatitis B or C
• Use of inducers or inhibitors of CYP3A4 within 2 weeks prior to the first dose of study medication. (Patients may be included if the patients who need to intake the medication such as cimetidine was keep the same dose continuously at 1 cycle and 2 cycle)
• Peripheral neuropathy ≥ Grade 2
• known resistant or uncontrolled severe hypersensitivity to docetaxel
• History of hypersensitivity reaction to Polysorbate 80
• The female patients of pregnancy, breast feeding or childbearing potential. And the patients has not laboratory result or the result was a positive serum pregnancy test, also Patients (M/F) with reproductive potential not implementing adequate contraceptive measurements. (In case of menopausal women, keeping menopause at least 12 months. All sexually active male patients must agree to use adequate methods of birth control throughout the study)
• Administration of any other tumor therapy, including chemotherapy, radiotherapy, and immunotherapy within 4 weeks before the beginning of study treatment. Patients may be included if the radiotherapy was conducted to relieve symptoms and that symptoms recovered to grade 1
• treated with any investigational drugs within 4 weeks before the beginning of study treatment
• Must be treated concurrent administration of other anti-cancer medicine
• Not able to participate to the study, at the discretion of the investigator

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Chong Kun Dang Pharmaceutical

Overall Clinical Trial Officials and Contacts

JH Kang Principal Investigator The Catholic university of KOREA, Seoul ST. Mary's Hospital  

Overall Contact: DR Lee 82-2-2194-0428 

Information obtained from ClinicalTrials.gov on March 18, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01019941

Study ID Number: CKD-810_PK_phase I

ClinicalTrials.gov Identifier: NCT01019941

Health Authority: Korea: Food and Drug Administration