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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01336582
• Other study ID #: DOCXN101
• Status: Completed
• Phase: Phase 1
• First received: March 21, 2011
• Last updated: December 19, 2012
• Start date: August 2009
• Est. completion date: August 2012

Study information

• Verified date: December 2012
• Source: Samyang Biopharmaceuticals Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Tumor

Intervention

Drug:
• taxotere
70 mg/m2 for age of = 65

Locations

Country	Name	City	State
Korea, Republic of	Inje Pusan paik University hospital	Pusan	Jin-Gu

Sponsors (1)

Lead Sponsor	Collaborator
Samyang Biopharmaceuticals Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of SYP-0704A and Taxotere in terms of AUC		3 months	No
Secondary	Pharmacokinetics of the T1/2 of SYP-0704A and Taxotere		3 months	No
Secondary	Pharmacokinetics of the CL of SYP-0704A and Taxotere		3 months	No
Secondary	Pharmacokinetics of the Vdss of SYP-0704A and Taxotere		3 months	No
Secondary	Number of paticipants with Adverse Events		3months	No