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Advanced Solid CancersPhase 1126ASC08QNCT01019941

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

A Phase 1 study testing CKD-810, Taxotere inj. in people with Advanced Solid Cancers, run by Chong Kun Dang Pharmaceutical at 7 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Cancers
What is being tested?
CKD-810, Taxotere inj.
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
7 sitesSouth Korea
Study dates
Aug 2009to Dec 2010
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

South Korea7 sites

  • Gachon University Gil Hospital

    Inchon

  • The Catholic university of KOREA, Seoul ST. Mary's Hospital

    Seoul

  • The Korea University Anam Hospital

    Seoul

  • Ajou University Hospital

    Suwon

  • Dongsan Medical Center, Keimyung University

    Taegu

  • Yeoungnam University Hospital

    Taegu

  • Ulsan University Hospital

    Ulsan

Other trials in South Korea

About this study

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

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.

Read the 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.

Being tested
CKD-810, Taxotere inj.
Keywords
Docetaxel, CKD-810, Taxotere inj., Advanced Solid cancer, Pharmacokinetic evaluation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CKD-810, Taxotere inj.Drug

    Also called Docetaxel anhydrous, Docetaxel

    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.Drug

    Also called Docetaxel anhydrous, Docetaxel

    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.

Study groups in NCT01019941
Study groupRoleWhat they receive
1st cycle:CKD-810 -> 2nd cycle:Taxotere inj.OtherNot described
Receives: Drug: CKD-810, Taxotere inj.
1st cycle:Taxotere inj.-> 2nd cycle:CKD-810OtherNot described
Receives: Drug: CKD-810, Taxotere inj.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetics of CKD-810 and Taxotere inj.

    Measured: 2 Cycles

Secondary outcomes (1)

  1. Safety of CKD-810 and Taxotere inj.

    Measured: 2 Cycles

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2009 (estimated)
  2. Study startAug 2009
  3. Primary completionAug 2010
  4. Study completionDec 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01019941
Sponsor's protocol ID
CKD-810_PK_phase I
Acronym
126ASC08Q
Status last verified
Dec 2010
First submitted
23 Nov 2009
Last updated
16 Dec 2010
Results posted
No
Data monitoring committee
No

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.

    PubMed 24337589

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CKD-810, Taxotere inj. in people with Advanced Solid Cancers, run by Chong Kun Dang Pharmaceutical at 7 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics of CKD-810 and Taxotere inj. (time frame: 2 Cycles). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01019941, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2010.

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