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

Phase I Trial to Compare Pharmacokinetics and Safety of SYP-0704A With Taxotere in Subjects With Advanced Solid Tumor

Primary Objective: Evaluation of the pharmacokinetic equivalence of two Docetaxel formulations in terms of AUC and Cmax.

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

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.