Pharmacokinetic Study of CKD-810 and Taxotere to Treat Patient With Advanced Solid Cancer (126ASC08Q)

This study has been completed.
Sponsor:
Information provided by:
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01019941
First received: November 23, 2009
Last updated: December 15, 2010
Last verified: December 2010

November 23, 2009
December 15, 2010
August 2009
August 2010   (final data collection date for primary outcome measure)
Pharmacokinetics of CKD-810 and Taxotere inj. [ Time Frame: 2 Cycles ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01019941 on ClinicalTrials.gov Archive Site
Safety of CKD-810 and Taxotere inj. [ Time Frame: 2 Cycles ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pharmacokinetic Study of CKD-810 and Taxotere to Treat Patient With Advanced Solid Cancer
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Solid Cancers
  • 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.
    Other Name: Docetaxel anhydrous, Docetaxel
  • 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.
    Other Name: Docetaxel anhydrous, Docetaxel
  • 1st cycle:CKD-810 -> 2nd cycle:Taxotere inj.
    Intervention: Drug: CKD-810, Taxotere inj.
  • 1st cycle:Taxotere inj.-> 2nd cycle:CKD-810
    Intervention: Drug: CKD-810, Taxotere inj.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
December 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01019941
CKD-810_PK_phase I
No
Jin Kim, Chong Kun Dang
Chong Kun Dang Pharmaceutical
Not Provided
Principal Investigator: JH Kang The Catholic University of Korea
Chong Kun Dang Pharmaceutical
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP