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

Samyang Biopharmaceuticals Corporation

Status and phase

Completed

Phase 1

Conditions

Solid Tumor

Treatments

Drug: taxotere

Study type

Interventional

Funder types

Industry

Identifiers

DOCXN101

Details and patient eligibility

About

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

Full description

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

Enrollment

42 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.