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

Malignant Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02805166
• Other study ID #: CSPC-PGC-IV-01/CSPC-PGC-IV-02
• Status: Completed
• Phase: Phase 4
• First received: June 13, 2016
• Last updated: June 16, 2016
• Start date: April 2013
• Est. completion date: February 2016

Study information

• Verified date: June 2016
• Source: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malignant Solid Tumors
• Neoplasms

Intervention

Drug:
• PEG-rhG-CSF

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The occurrence rate of adverse event during at least three consecutive cycles chemotherapy		up to 30 days after the patient study completion	No
Primary	The severity of adverse event during at least three consecutive cycles chemotherapy		up to 30 days after the patient study completion	No
Secondary	the non-occurrence rate of grade IV neutropenia (ANC <0.5 x 10^9/L)during at least three consecutive cycles chemotherapy		through the study completion,an average of 5 months	No
Secondary	the duration of grade IV neutropenia(ANC <0.5 x 10^9/L) during at least three consecutive cycles chemotherapy		through the study completion,an average of 5 months	No