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Completed

NCT Number: NCT02972216

Post-marketing Surveillance Study of Docetaxel-Based Chemotherapy

A Post-marketing Surveillance Study to Evaluate the Effectiveness and Safety of Docetaxel-Based Chemotherapy

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

-Histologically or cytologically confirmed unresectable locally advanced NSCLC with progressed or recurred after no more than four previous docetaxel-free chemotherapy regimens, or unresectable locally advanced or metastatic SCCHN or recurred after previous docetaxel-free chemotherapy regimens

Exclusion criteria

  • Women who are nursing or pregnant during the study period;
  • Patients with carcinoid tumors, small-cell carcinoma of the lung;
  • A history of another malignancy within the last five years (except for cured basal cell carcinoma of the skin and cured carcinoma in situ of the uterine cervix);
  • Any other morbidity or situation with contraindications for chemotherapy (e.g. active infection, myocardial infarction in the preceding 6 months);
  • Neutrophil counts < 1,500 cells/mm3;
  • A history of hypersensitivity to docetaxel or cisplatin;
  • Symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias;
  • Subjects have active hepatitis;
  • Subjects are known positive for Human Immunodeficiency Virus (HIV);
  • Any condition judged by investigator, participates the study will jeopardize patient's wellbeing

Treatment and study plan

Nolbaxol

Drug

Other names: docetaxel

Taxotere

Drug

Other names: docetaxel

Cisplatin

Drug

Primary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: Every 8 weeks after post-dosing follow-up visit, and conducted until disease progression or up to 11 months.

Secondary outcomes

  1. Overall Response Rate (ORR)

    Time frame: Every 8 weeks after post-dosing follow-up visit, and conducted until disease progression or up to 11 months.

  2. Adverse Events as a measure on safety

    Time frame: Adverse event will be evaluated during the study regimens treatment period and up to 8 weeks after the last dose of study regimen visit.

Sponsors and collaborators

Lead sponsor

Yung Shin Pharm. Ind. Co., Ltd.

Industry

Collaborators

  • National Cheng-Kung University Hospital
  • Taichung Veterans General Hospital
  • Tri-Service General Hospital (TSGH)

Registry information

Official study title

A Post-marketing Surveillance Study to Evaluate the Effectiveness and Safety of Docetaxel-Based Chemotherapy

Important dates

Study start
2014
Primary completion
2016
First posted
Nov 23, 2016
Registry last updated
Nov 23, 2016

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.

Published trials that share one or more normalized conditions with this study.