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Completed

NCT Number: NCT01336582

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

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

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Key information

Conditions

Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Inje Pusan paik University hospital

Pusan, Jin-Gu, 614-735, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Taxotere

Drug

70 mg/m2 for age of ≥ 65

Primary outcomes

  1. Pharmacokinetics of SYP-0704A and Taxotere in terms of AUC

    Time frame: 3 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Samyang Biopharmaceuticals Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Apr 18, 2011
Registry last updated
Dec 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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