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
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

ClinicalTrials.gov processed this record on April 17, 2014