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

Phase 1

Completed

• Conditions: Solid Tumor
• Interventions: Drug: taxotere

• Registration Number: NCT01336582
• Lead Sponsor: Samyang Biopharmaceuticals Corporation

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2011-03-21
• Study First Submitted QC: 2011-04-14
• Study First Posted: 2011-04-18
• Primary Completion: 2012-04
• Study Completion: 2012-08
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-19
• Last Update Posted: 2012-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
docetaxel	taxotere	-
Taxotere	taxotere	Docetaxel-PM 75 mg/m2 (70 mg/m2 for age of ≥ 65) Taxotere 75mg/m2 (70 mg/m2 for age of ≥ 65)

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of SYP-0704A and Taxotere in terms of AUC	3 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Inje Pusan paik University hospital; 🇰🇷 Pusan, Jin-Gu, Korea, Republic of