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

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

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

Study Overview

• Status: Completed
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: taxotere

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jin-Gu
    • Pusan, Jin-Gu, Korea, Republic of, 614-735
      • Inje Pusan paik University hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics of SYP-0704A and Taxotere in terms of AUC	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Samyang Biopharmaceuticals Corporation
• Investigators: Principal Investigator: Shin je gook, doctor, Inje Pusan paik University hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: March 21, 2011
• First Submitted That Met QC Criteria: April 14, 2011
• First Posted (Estimate): April 18, 2011

Study Record Updates

• Last Update Posted (Estimate): December 21, 2012
• Last Update Submitted That Met QC Criteria: December 19, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Advanced Solid Tumor; suitable candidate; single agent docetaxel therapy
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: DOCXN101