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

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samyang Biopharmaceuticals Corporation
• Treatments: Docetaxel

Criteria

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.