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

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 Overview

• Status: Completed
• Conditions: Advanced Solid Cancers
• Intervention / Treatment: Drug: CKD-810, Taxotere inj.; Drug: CKD-810, 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.

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Inchon, Korea, Republic of
    • Gachon University Gil Hospital
  • Seoul, Korea, Republic of
    • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Seoul, Korea, Republic of
    • The Korea University Anam Hospital
  • Suwon, Korea, Republic of
    • Ajou University Hospital
  • Taegu, Korea, Republic of
    • Dongsan Medical Center, Keimyung University
  • Taegu, Korea, Republic of
    • Yeoungnam University Hospital
  • Ulsan, Korea, Republic of
    • Ulsan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: 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 Names: Docetaxel anhydrous, Docetaxel
Other: 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, 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 Names: 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 Names: Docetaxel anhydrous, Docetaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics of CKD-810 and Taxotere inj.	2 Cycles

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety of CKD-810 and Taxotere inj.	2 Cycles

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: JH Kang, The Catholic University of Korea

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: November 23, 2009
• First Submitted That Met QC Criteria: November 24, 2009
• First Posted (Estimate): November 25, 2009

Study Record Updates

• Last Update Posted (Estimate): December 16, 2010
• Last Update Submitted That Met QC Criteria: December 15, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: Docetaxel; CKD-810; Taxotere inj.; Advanced Solid cancer; Pharmacokinetic evaluation
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: CKD-810_PK_phase I