NCT02805166

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2013

Typical duration for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
Last Updated

June 17, 2016

Status Verified

June 1, 2016

Enrollment Period

2.8 years

First QC Date

June 13, 2016

Last Update Submit

June 16, 2016

Conditions

Malignant Solid Tumors

Keywords

PEG-rhG-CSF

Outcome Measures

Primary Outcomes (2)

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

    up to 30 days after the patient study completion

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

    up to 30 days after the patient study completion

Secondary Outcomes (2)

  • 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

  • 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

Study Arms (1)

PEG-rhG-CSF

EXPERIMENTAL

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

Interventions

PEG-rhG-CSFDRUG
Also known as: pegfilgrastim
PEG-rhG-CSF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

pegylated granulocyte colony-stimulating factorpegfilgrastim

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2016

First Posted

June 17, 2016

Study Start

April 1, 2013

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

June 17, 2016

Record last verified: 2016-06