NCT01560195

Brief Summary

Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b and phase 2 trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with filgrastim. The purpose of this study is to determine the safety and effectiveness of pegylated rhG-CSF in preventing neutropenia following chemotherapy in patients with advanced NSCLC.

Trial Health

55
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Trial Health Score

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

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 22, 2012

Completed
10 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Last Updated

November 6, 2012

Status Verified

November 1, 2012

Enrollment Period

9 months

First QC Date

March 8, 2012

Last Update Submit

November 4, 2012

Conditions

NSCLCNeutropeniaFebrile Neutropenia

Keywords

neutropeniafebrile neutropeniachemotherapy

Outcome Measures

Primary Outcomes (1)

  • Rate of grade 3/4 neutropenia in cycle 1

    the rate of ANC lower than 1.0 × 109/L

    21 days

Secondary Outcomes (8)

  • Incidence of febrile neutropenia in cycle 1

    21 days

  • Rate of grade 3/4 neutropenia and incidence of febrile neutropenia in cycle 2 to 4

    Through 2 to 4 cycles

  • Time to neutrophil recovery in the 4 chemotherapy cycles

    Through 4 cycles

  • Duration of 3/4 neutropenia in the 4 chemotherapy cycles

    Through 4 cycles

  • Objective response rate

    Through 4 cycles

  • +3 more secondary outcomes

Study Arms (3)

Pegylated rhG-CSF: 100µg/kg

EXPERIMENTAL

Staged III or IV NSCLC patients receiving chemotherapy and Pegylated rhG-CSF 100µg/kg

Drug: Pegylated rhG-CSF: 100µg/kg

Pegylated rhG-CSF: 6mg

EXPERIMENTAL

Staged III or IV NSCLC patients receiving chemotherapy and pegylated rhG-CSF 6mg

Drug: Pegylated rhG-CSF: 6mg

Placebo

PLACEBO COMPARATOR

Staged III or IV NSCLC patients receiving chemotherapy and placebo in cycle 1 and rhG-CSF in cycle 2 to 4

Drug: placebo and rhG-CSF 5ug/kg/d

Interventions

Pegylated rhG-CSF: 100µg/kgDRUG

Patients were administered pegylated rhG-CSF 100 ug/kg once at the 3rd day of every chemotherapy cycle. Chemotherapy regimen: docetaxel 75 mg/m2; carboplatin area under curve\[AUC\] 5 or cisplatin 75 mg/m2.

Pegylated rhG-CSF: 100µg/kg
Pegylated rhG-CSF: 6mgDRUG

Patients were administered pegylated rhG-CSF 6mg once at the 3rd day of every chemotherapy cycle. Chemotherapy regimen: docetaxel 75 mg/m2; carboplatin area under curve\[AUC\] 5 or cisplatin 75 mg/m2.

Pegylated rhG-CSF: 6mg
placebo and rhG-CSF 5ug/kg/dDRUG

Patients receiving chemotherapy and placebo in cycle 1 and rhG-CSF 5ug/kg/d in cycle 2 to 4. Chemotherapy regimen: docetaxel 75 mg/m2; carboplatin area under curve\[AUC\] 5 or cisplatin 75 mg/m2.

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Investigator diagnosis of staged III or IV NSCLC
  • Age 18 to 70 years
  • ECOG performance status ≤ 1
  • Chemotherapy naïve
  • Body weight ≥ 45kg
  • Hemoglobin ≥ 100g/L; white blood cell ≥ 4.0×109/L; absolute neutrophil count ≥1.5 × 109/L; platelet count ≥ 100 × 109/L
  • Alanine transarninase ≤1.5×ULN; aspartate aminotransferase ≤1.5×ULN; serum creatinine ≤1.5×ULN; total bilirubin ≤1.5×ULN

You may not qualify if:

  • History of systematic chemotherapy or radical radiation therapy
  • Prior bone marrow or stem cell transplantation
  • Received systemic antibiotics treatment within 72 h of chemotherapy
  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Conditions

NeutropeniaFebrile Neutropenia

Condition Hierarchy (Ancestors)

AgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte Disorders

Study Officials

  • Caicun Zhou

    Shanghai Pulmonary Hospital, Shanghai, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Caicun Zhou, M. D.

CONTACT

862165115006caicunzhou@yahoo.com.cn

Haoyuan Jiang, Ph. D.

CONTACT

862168868768jianghy@shhrp.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2012

First Posted

March 22, 2012

Study Start

April 1, 2012

Primary Completion

January 1, 2013

Last Updated

November 6, 2012

Record last verified: 2012-11

Locations

CN(1)