Pharmacokinetic Study of SYP-0704A and Taxotere to Treat Patient With Advanced Solid Cancer

Study Overview
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Brief Summary
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Primary Objective: 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 SYP-0704A With Taxotere in Subjects With Advanced Solid Tumor

Conditions
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Solid Tumor

Intervention / Treatment
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* Drug: taxotere


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who aged 18 years or older. Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial. Subjects who have histologically or cytologically confirmed advanced solid tumor. Subjects who are a suitable candidate for single agent docetaxel therapy for their advanced solid tumors that have failed to standard therapy. Subjects who have fully recovered from reversible toxic effects of prior therapy. The prior chemotherapy, immunotherapy, hormone therapy, surgery, and/or radiotherapy should be completed at least 21 days before the first administration of investigational product. Exclusion Criteria: Subjects who have had a major surgery other than tumor ablation within 2 weeks prior to the screening/baseline visit. Subjects who have a history of metastasis or currently have a metastasis to the central nervous system (CNS). Subjects who have a preexisting sensory or motor neuropathy of grade ≥ 2 based on NCI CTCAE V3.0.

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: docetaxel<br> | Drug: taxotere<br>* 70 mg/m2 for age of ≥ 65<br>|
| Active Comparator: Taxotere<br>Docetaxel-PM 75 mg/m2 (70 mg/m2 for age of ≥ 65) Taxotere 75mg/m2 (70 mg/m2 for age of ≥ 65) | Drug: taxotere<br>* 70 mg/m2 for age of ≥ 65<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of SYP-0704A and Taxotere in terms of AUC |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of the T1/2 of SYP-0704A and Taxotere |  | 3 months | 
| Pharmacokinetics of the CL of SYP-0704A and Taxotere |  | 3 months | 
| Pharmacokinetics of the Vdss of SYP-0704A and Taxotere |  | 3 months | 
| Number of paticipants with Adverse Events |  | 3months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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suitable candidate, single agent docetaxel therapy, Advanced Solid Tumor