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OpenTrials
Completed

NCT Number: NCT02805166

PEG-rhG-CSF in Patients With Malignant Solid Tumors Receiving Chemotherapy

The purpose of this study is to estimate the safety and efficacy of PEG-rhG-CSF in patients with lung cancer,head and neck cancer,colorectal cancer,and ovarian cancer receiving multi-cycle chemotherapy.

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Key information

Conditions

Malignant Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with age ≥ 18 years
  • diagnosis of lung cancer,head and neck cancer,colorectal cancer,ovarian cancer
  • Karnofsky Performance Status ≥ 70
  • life expectancy of at least 3 months
  • Written informed consent are acquired

Exclusion criteria

  • uncontrolled infection,Temperature is 38.0 ℃ or higher
  • pregnancy
  • Other situations that investigators consider as contra-indication for this study

Treatment and study plan

PEG-rhG-CSF

Drug

Other names: pegfilgrastim

Primary outcomes

  1. The occurrence rate of adverse event during at least three consecutive cycles chemotherapy

    Time frame: up to 30 days after the patient study completion

  2. The severity of adverse event during at least three consecutive cycles chemotherapy

    Time frame: up to 30 days after the patient study completion

Secondary outcomes

  1. the non-occurrence rate of grade IV neutropenia (ANC <0.5 x 10^9/L)during at least three consecutive cycles chemotherapy

    Time frame: through the study completion,an average of 5 months

  2. the duration of grade IV neutropenia(ANC <0.5 x 10^9/L) during at least three consecutive cycles chemotherapy

    Time frame: through the study completion,an average of 5 months

Sponsors and collaborators

Lead sponsor

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Industry

Registry information

Official study title

The Multi-center,Open-label,Single Arm Phase IV Clinical Trial of Efficacy and Safety of PEG-rhG-CSF in Patients With Lung Cancer,Head and Neck Cancer,Colorectal Cancer,Ovarian Cancer and the Other Cancer Receiving Chemotherapy

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 17, 2016
Registry last updated
Jun 17, 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.

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