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

This study has been completed.
Information provided by (Responsible Party):
Samyang Biopharmaceuticals Corporation Identifier:
First received: March 21, 2011
Last updated: December 19, 2012
Last verified: December 2012
Primary Objective: Evaluation of the pharmacokinetic equivalence of two Docetaxel formulations in terms of AUC and Cmax.

Condition Intervention Phase
Solid Tumor
Drug: taxotere
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Samyang Biopharmaceuticals Corporation:

Primary Outcome Measures:
  • Pharmacokinetics of SYP-0704A and Taxotere in terms of AUC [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Pharmacokinetics of the T1/2 of SYP-0704A and Taxotere [ Time Frame: 3 months ]
  • Pharmacokinetics of the CL of SYP-0704A and Taxotere [ Time Frame: 3 months ]
  • Pharmacokinetics of the Vdss of SYP-0704A and Taxotere [ Time Frame: 3 months ]
  • Number of paticipants with Adverse Events [ Time Frame: 3months ]

Enrollment: 42
Study Start Date: August 2009
Study Completion Date: August 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
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Please refer to this study by its identifier: NCT01336582

Korea, Republic of
Inje Pusan paik University hospital
Pusan, Jin-Gu, Korea, Republic of, 614-735
Sponsors and Collaborators
Samyang Biopharmaceuticals Corporation
Principal Investigator: Shin je gook, doctor Inje Pusan Paik university hospital
  More Information

Responsible Party: Samyang Biopharmaceuticals Corporation Identifier: NCT01336582     History of Changes
Other Study ID Numbers: DOCXN101
Study First Received: March 21, 2011
Last Updated: December 19, 2012

Keywords provided by Samyang Biopharmaceuticals Corporation:
suitable candidate
single agent docetaxel therapy
Advanced Solid Tumor

Additional relevant MeSH terms:
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017