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

• Sponsor: Samyang Biopharmaceuticals Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01336582
• Collaborator: (none)
• Enrollment: 42
• Location: 1
• Arms: 2
• Duration (Months): 36
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor	Drug: taxotere	Phase 1

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase I Trial to Compare Pharmacokinetics and Safety of SYP-0704A With Taxotere in Subjects With Advanced Solid Tumor
• Study Start Date: Aug 1, 2009
• Actual Primary Completion Date: Apr 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: docetaxel	Drug: taxotere; 70 mg/m2 for age of ≥ 65
Active Comparator: Taxotere Docetaxel-PM 75 mg/m2 (70 mg/m2 for age of ≥ 65) Taxotere 75mg/m2 (70 mg/m2 for age of ≥ 65)	Drug: taxotere; 70 mg/m2 for age of ≥ 65

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics of SYP-0704A and Taxotere in terms of AUC [3 months]

Secondary Outcome Measures

1. Pharmacokinetics of the T1/2 of SYP-0704A and Taxotere [3 months]

2. Pharmacokinetics of the CL of SYP-0704A and Taxotere [3 months]

3. Pharmacokinetics of the Vdss of SYP-0704A and Taxotere [3 months]

4. Number of paticipants with Adverse Events [3months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Inje Pusan paik University hospital	Pusan	Jin-Gu	Korea, Republic of	614-735

Sponsors and Collaborators

• Samyang Biopharmaceuticals Corporation

Investigators

• Principal Investigator: Shin je gook, doctor, Inje Pusan Paik university hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Samyang Biopharmaceuticals Corporation
• ClinicalTrials.gov Identifier: NCT01336582
• Other Study ID Numbers: DOCXN101
• First Posted: Apr 18, 2011
• Last Update Posted: Dec 21, 2012
• Last Verified: Dec 1, 2012

• Keywords provided by Samyang Biopharmaceuticals Corporation: suitable candidate; single agent docetaxel therapy; Advanced Solid Tumor
• Additional relevant MeSH terms: Docetaxel

Study Results

No Results Posted as of Dec 21, 2012