Pharmacokinetic Study of Docetaxel-PNP and Taxotere to Treat Patient With Advanced Solid Cancer

Study Overview
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Brief Summary
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Evaluation of the pharmacokinetic equivalence of two Docetaxel formulations in terms of AUC and Cmax

Detailed Description
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Comparison of pharmacokinetic parameters (T1/2β, CL, Vdss) Safety as measured by adverse events

Official Title
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Phase I Trial to Compare Pharmacokinetics and Safety of Docetaxel PNP With Taxotere in Subjects With Advanced Solid Tumor

Conditions
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Solid Tumor

Intervention / Treatment
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* Drug: Docetaxel-PNP
* Drug: Taxotere


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient ages more than 18 years old Patient should voluntarily sign a written informed consent before study entry Patient historically or cytologically confirmed diagnosis of advanced solid tumor and patient with measurable disease or evaluable disease by RECIST criteria Progressive disease with development of new lesions or an increase in preexisting lesions or standard therapy in order to provide clinical benefit does not exist or is no longer effective Previous anti-cancer therapies must be completed before 21days of first study dose and Patient must have recovered from any previous therapy Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 Patient has a life expectancy of at least 3 months Baseline studies for determining eligibility must be completed within 14 days of first study dose and patient has a adequate organ function including the following: Hb ≥ 10g/dl ANC ≥ 1.5 X 109/L Platelet count ≥ 100 X 109/L Serum total bilirubin ≤ 1.5 mg/dL Serum AST and ALT ≤ 2.5 X UNL Serum ALP ≤ 2.5ⅹUNL Serum creatinine ≤ 1.5 X UNL Exclusion Criteria: Patient has had a major surgery except tumor ablation within 2 weeks before screening visit Patient has a brain metastasis with neurologic symptom Patient has a sensory neuropathy or motor neuropathy ≥ grade 2 by NCI-CTCAE Patient has any serious concurrent disease such as: Any medical or psychiatric condition that, in the opinion of the investigator, would prohibit the understanding and giving of informed consent Severe cardiovascular disease (e.g. ischemic heart disease requiring medication or myocardial infraction within the past six months, grade 3-4 congestive heart failure defined by the New York Heart Association criteria) Active un controlled infection. Patient has hypersensitivity to the Investigational product or their excipients Patient has participated in any other clinical trial within 4 weeks before screening visit Woman is pregnant or breast feeding Subjects who are of childbearing potential who do not use a medically acceptable method of birth control or do not agree to continue use of this method throughout the trial (screening, treatment period, and 3 weeks from the last done). A negative pregnancy test (urine or serum) should be documented within 14 days prior to initiation of trial medication for women of childbearing potential who have not been amenorrheic for at least 12 months prior to registration into the trial or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy). Medically acceptable methods include: Barrier method with spermicide Intrauterine device Complete abstinence, etc.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Period 1: Docetaxel-PNP / Washout: 3 weeks / Period 2: Taxotere | Drug: Docetaxel-PNP<br>* Docetaxel Polymeric Nanoparticle Formulation<br>Drug: Taxotere<br>* Docetaxel<br>|
| Experimental: Group B<br>Period 1: Taxotere / Washout: 3 weeks / Period 2: Docetaxel-PNP | Drug: Docetaxel-PNP<br>* Docetaxel Polymeric Nanoparticle Formulation<br>Drug: Taxotere<br>* Docetaxel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of DocetaxelPNP and Taxotere in terms of Area Under the Curve (AUC) |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elimination Half Life (T1/2) of DocetaxelPNP and Taxotere |  | 3 months | 
| Clearance (CL) of DocetaxelPNP and Taxotere |  | 3 months | 
| Volume of Distribution at steady state (Vdss) of DocetaxelPNP and Taxotere |  | 3 months | 
| Number of participants with Adverse Events |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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docetaxel, Pharmacokinetic