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

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ClinicalTrials.gov Identifier: NCT02805166
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : June 17, 2016
Sponsor:
Information provided by (Responsible Party):
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Malignant Solid Tumors Drug: PEG-rhG-CSF Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 420 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official 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
Study Start Date : April 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016


Arm Intervention/treatment
Experimental: PEG-rhG-CSF
patients received a single dose of 100 ug/kg of PEG-rhG-CSF(pegfilgrastim), on the basis of actual body weight, as a single subcutaneous injection on day 3 after chemotherapy.
Drug: PEG-rhG-CSF
Other Name: pegfilgrastim




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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Responsible Party: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02805166     History of Changes
Other Study ID Numbers: CSPC-PGC-IV-01/CSPC-PGC-IV-02
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: June 17, 2016
Last Verified: June 2016

Keywords provided by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.:
PEG-rhG-CSF

Additional relevant MeSH terms:
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Neoplasms