Pharmacokinetic Study of CKD-810 and Taxotere to Treat Patient With Advanced Solid Cancer
Information source: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Advanced Solid Cancers
Intervention: CKD-810, Taxotere inj. (Drug); CKD-810, Taxotere inj. (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Chong Kun Dang Pharmaceutical Official(s) and/or principal investigator(s):
JH Kang, Principal Investigator, Affiliation: The Catholic University of Korea
Summary
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Pharmacokinetics of CKD-810 and Taxotere inj.
Secondary outcome: Safety of CKD-810 and Taxotere inj.
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Gachon University Gil Hospital, Inchon, Korea, Republic of
The Catholic university of KOREA, Seoul ST. Mary's Hospital, Seoul, Korea, Republic of
The Korea University Anam Hospital, Seoul, Korea, Republic of
Ajou University Hospital, Suwon, Korea, Republic of
Dongsan Medical Center, Keimyung University, Taegu, Korea, Republic of
Yeoungnam University Hospital, Taegu, Korea, Republic of
Ulsan University Hospital, Ulsan, Korea, Republic of
Additional Information
Starting date: August 2009
Last updated: December 15, 2010
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