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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01336582
Recruitment Status : Completed
First Posted : April 18, 2011
Last Update Posted : December 21, 2012
Information provided by (Responsible Party):
Samyang Biopharmaceuticals Corporation

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 Type : Interventional  (Clinical Trial)
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 : August 2009
Actual Primary Completion Date : April 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel
U.S. FDA Resources

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

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

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

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Samyang Biopharmaceuticals Corporation Identifier: NCT01336582     History of Changes
Other Study ID Numbers: DOCXN101
First Posted: April 18, 2011    Key Record Dates
Last Update Posted: December 21, 2012
Last Verified: December 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