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
  Purpose

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.


Condition Intervention Phase
Advanced Solid Cancers
Drug: CKD-810, Taxotere inj.
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Chong Kun Dang Pharmaceutical:

Primary Outcome Measures:
  • Pharmacokinetics of CKD-810 and Taxotere inj. [ Time Frame: 2 Cycles ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety of CKD-810 and Taxotere inj. [ Time Frame: 2 Cycles ] [ Designated as safety issue: No ]

Estimated Enrollment: 44
Study Start Date: August 2009
Study Completion Date: December 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1st cycle:CKD-810 -> 2nd cycle:Taxotere inj. 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
1st cycle:Taxotere inj.-> 2nd cycle:CKD-810 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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01019941

Locations
Korea, Republic of
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
Yeoungnam University Hospital
Taegu, Korea, Republic of
Dongsan Medical Center, Keimyung University
Taegu, Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
Principal Investigator: JH Kang The Catholic University of Korea
  More Information

No publications provided by Chong Kun Dang Pharmaceutical

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jin Kim, Chong Kun Dang
ClinicalTrials.gov Identifier: NCT01019941     History of Changes
Other Study ID Numbers: CKD-810_PK_phase I
Study First Received: November 23, 2009
Last Updated: December 15, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Chong Kun Dang Pharmaceutical:
Docetaxel
CKD-810
Taxotere inj.
Advanced Solid cancer
Pharmacokinetic evaluation

Additional relevant MeSH terms:
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014