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Chemotherapy Induced NeutropeniaPhase 2/3NCT01328938

GCPGC in Chemotherapy-induced Neutropenia

A Phase 2/3 study testing GCPGC 3.6mg, GCPGC 6mg and Neulasta (pegfilgrastim) 6mg in people with Chemotherapy Induced Neutropenia, run by Green Cross Corporation at 15 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is adaptive design and it consists of stage I and stage II. Stage I is multi-center, parallel-group, single-blind, phase II study to determine the adequate dose of GCPGC in chemotherapy-induced neutropenia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chemotherapy Induced Neutropenia
What is being tested?
GCPGC 3.6mg, GCPGC 6mg and Neulasta (pegfilgrastim) 6mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
177 participants
Where
15 sitesSouth Korea
Study dates
Oct 2010to May 2013
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • women(≥ 18 years old) diagnosed with breast cancer who are receiving chemotherapy inducing neutropenia
  • body weight of 45kg and more
  • ECOG performance status 2 and less
  • ANC ≥1,500mm3 and Platelet ≥100,000/mm3
  • life expectancy of 3 months and more
  • given written informed consent

Who cannot join

  • had previous exposure to pegfilgrastim or filgrastim
  • had received systemic antibiotics within 72hrs of chemotherapy
  • prior total cumulative lifetime exposure to doxorubicin more than 240 mg/m or epirubicin more than 600 mg/m

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

South Korea15 sites

  • Chungbuk National University Hospital

    Chungju, Chungchungbuk

  • Keimyung University Dongsan medical Center

    Daegu

  • National Cancer Center

    Ilsan, KyungKi

  • Gachon University Gil Hospital

    Incheon, KyungKi

  • Pusan National University Hospital

    Pusan

  • Chung-Ang University Hospital

    Seoul

  • Inha University Hospital

    Seoul

  • Konkuk University Medical Center

    Seoul

  • Kyung Hee University Medical Center

    Seoul

  • Seoul Asan Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

  • Seoul St.Mary's Hospital

    Seoul

  • SMG-SNU Boramae Medical Center

    Seoul

  • Seoul National University Bundang Hospital

    Sungnam, Kyungki

  • Ulsan University Hospital

    Ulsan

Other trials in South Korea

About this study

Official title: A Randomized,Multi-center,Parallel-group, Phase II(Single-blind)/Phase III(Double- Blind)Study to Determine the Optimal Dose and to Evaluate the Efficacy and Safety of GCPGC on Chemotherapy-induced Neutropenia Compared to Neulasta(Pegfilgrastim)

This study is adaptive design and it consists of stage I and stage II.

Stage I is multi-center, parallel-group, single-blind, phase II study to determine the adequate dose of GCPGC in chemotherapy-induced neutropenia. 2 Different doses of GCPGC will be investigated in a total of 60 Breast cancer patients who are receiving chemotherapy.

Stage II is multi-center, parallel-group, double-blind,phase III study to evaluate the efficacy and safety of once per cycle GCPGC in chemotherapy-induced neutropenia compared to Neulasta (pegfilgrastim). A total of 120 patients receiving chemotherapy will participate into this phase.

Read the detailed description

GCPGC ia a solution for containing pegfilgrastim. Pegfilgrastim is a covalent conjugate of recombinant human granulocyte colony-stimulating factor (G-CSF) with a polyethylene glycol (PEG) which has long half life compared to filgrastim, resulting in dosing advantage.

Being tested
GCPGC 3.6mg, GCPGC 6mg, Neulasta (pegfilgrastim) 6mg
Keywords
Pegfilgrastim, neutropenia
Medical subject headings
Neutropenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GCPGC 3.6mgBiological

    Also called Pegfilgrastim

    Stage I:Single blinded

  • GCPGC 6mgBiological

    Also called Pegfilgrastim

    Stage I: Single blinded;

  • Neulasta (pegfilgrastim) 6mgBiological

    Stage II: Active comparator, double blinded

  • GCPGC 6mgBiological

    Also called Pegfilgrastim

    Experimental: Stage II

Study groups in NCT01328938
Study groupRoleWhat they receive
Stage I - Arm I: GCPGC I (3.6mg)ExperimentalGCPGC 3.6mg, sc, once at Day 2 per cycle (in patients receiving chemotherapy at Day 1)
Receives: Biological: GCPGC 3.6mg
Stage I - Arm II: GCPGC II (6mg)ExperimentalGCPGC 6mg, sc, once at Day 2 per cycle (in patients receiving chemotherapy at Day 1)
Receives: Biological: GCPGC 6mg
Stage II - Arm I: GCPGCExperimentalGCPGC 6mg, sc, once at Day 2 per cycle (in patients receiving chemotherapy at Day 1). The recommended dose in Stage II was determinated as GCPGC 6mg in Stage I.
Receives: Biological: GCPGC 6mg
Stage II - Arm II: NeulastaActive comparatorNeulasta 6mg, sc, once at Day 3 per cycle (in patients receiving chemotherapy at Day 1)
Receives: Biological: Neulasta (pegfilgrastim) 6mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration of grade 4 neutropenia(ANC<500mm3) for cycle 1

    Stage I: The difference in mean duration of grade 4 neutropenia between GCPGC 3.6mg and GCPGC 6mg is measured by check ANC in cycle I.

    Stage II : The difference in mean duration of grade 4 neutropenia between GCPGC which dose was determined at Stage I and Neulasta is measured by check ANC in cycle 1.

    Measured: in cycle 1

Secondary outcomes (8)

  1. Time to ANC recovery (≥2,000/mm3) after nadir in cycle 1

    Measured: in cycle 1

  2. Depth of ANC nadir in cycle 1

    Measured: in cycle 1

  3. Rates of Febrile neutropenia in all cycles

    Stage I: only in cycle 1; Stage II: in all cycles

    Measured: in all cycles

  4. Rates of severe neutropenia persisting more than 3 days in cycle 1 (only for Stage II)

    Measured: in cycle 1

  5. ANC values at Day 7 in all cycles (only for Stage II)

    Measured: Day 7 in alll cycles

  6. Rates of delay or dose-reduction of chemotherapy due to neutropenia (only for Stage II)

    Measured: all cycles

  7. Number of hospitalization due to febrile neutropenia in cycle 2 and after (only for Stage II)

    Measured: in clycle 2-6

  8. Number of intravenous antimicrobial treatments due to febrile neutropenia

    Measured: in all cycles

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2011 (estimated)
  2. Study startOct 2010
  3. Primary completionNov 2012
  4. Study completionMay 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
177 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01328938
Sponsor's protocol ID
GCPGC P2/3
Status last verified
Nov 2013
First submitted
6 Feb 2011
Last updated
6 Nov 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing GCPGC 3.6mg, GCPGC 6mg and Neulasta (pegfilgrastim) 6mg in people with Chemotherapy Induced Neutropenia, run by Green Cross Corporation at 15 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of grade 4 neutropenia(ANC<500mm3) for cycle 1 (time frame: in cycle 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01328938.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2013.

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