Pharmacokinetic Study of CKD-810 and Taxotere to Treat Patient With Advanced Solid Cancer

Advanced Solid Cancers Clinical Trial

— 126ASC08Q  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01019941
• Other study ID #: CKD-810_PK_phase I
• Status: Completed
• Phase: Phase 1
• First received: November 23, 2009
• Last updated: December 15, 2010
• Start date: August 2009
• Est. completion date: December 2010

Study information

• Verified date: December 2010
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Advanced Solid Cancers

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, 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.
• 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.

Locations

Country	Name	City	State
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	Dongsan Medical Center, Keimyung University	Taegu
Korea, Republic of	Yeoungnam University Hospital	Taegu
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of CKD-810 and Taxotere inj.		2 Cycles	No
Secondary	Safety of CKD-810 and Taxotere inj.		2 Cycles	No