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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Samyang Biopharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT01336582
First received: March 21, 2011
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

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
Endpoint Classification: Pharmacokinetics Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics of the T1/2 of SYP-0704A and Taxotere [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Pharmacokinetics of the CL of SYP-0704A and Taxotere [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Pharmacokinetics of the Vdss of SYP-0704A and Taxotere [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Number of paticipants with Adverse Events [ Time Frame: 3months ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01336582

Locations
Korea, Republic of
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
  More Information

No publications provided

Responsible Party: Samyang Biopharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT01336582     History of Changes
Other Study ID Numbers: DOCXN101
Study First Received: March 21, 2011
Last Updated: December 19, 2012
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Neoplasms
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014