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Chemotherapy-induced NeutropeniaPhase 2NCT02465801

Study of Recombinant Human Serum Albumin/Granulocyte Colony-Stimulating Factor Fusion Protein

A Phase 2 study testing HSA-GCSF 1.2 mg, HSA-GCSF 1.5 mg and GCSF in people with Chemotherapy-induced Neutropenia, run by Tianjin SinoBiotech Ltd. at 1 site in China.

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

The purpose of this study is to evaluate the dosages of recombinant human serum albumin/granulocyte colony-stimulating factor fusion protein by injection for preventing neutrophilic granulocytopenia among chemotherapy patients. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Chemotherapy-induced Neutropenia
What is being tested?
HSA-GCSF 1.2 mg, HSA-GCSF 1.5 mg and GCSF
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
216 participants
Where
1 siteChina
Study dates
16 Dec 2014to 26 Apr 2016
Phase
Phase 2
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 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-65.
  • Diagnosed breast cancer, suitable for TEC or TE .
  • ECOG performance status 0 or 1.
  • Adjuvant chemotherapy; new adjuvant chemotherapy; newly diagnosed class Ⅳ and prior chemotherapy.
  • ANC≥1.5×10 9/L, PLT≥100×10 9/L. No bone marrow metastasis,blood coagulation function normally, no Hemorrhagic tendency.
  • No obvious abnormal ecg examination.
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  • TBIL, ALT, AST≤2.5×ULN (≤5×ULN if presence of hepatic metastases).
  • Cr, BUN≤2.5×ULN.
  • Signed informed consent.

Who cannot join

  • Chemotherapy within past 4 weeks
  • Uncontrolled inflammatory disease,axillary temperature≥38℃.
  • Merging other malignant tumor
  • Pregnancy or nursing status.
  • Participation in another clinical trial with and investigational product within 3 months prior to study entry.
  • Severe diabetes mellitus, or poor blood sugar controller.
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  • Allergic disease or allergic constitution. History of protein allergy.
  • History of drug addiction and alcoholism.
  • Hematopoietic stem cell transplantation or organ transplantation.
  • Chronic disease of severe cardiac, kidney and liver.
  • Other conditions that would be excluded from this study according to doctors'judgment

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Hospital, Chinese Academy of Medical Scienses

    Beijing, 100021

Other trials in China

About this study

Official title: Efficacy and Safety Phase II Study of Recombinant Human Serum Albumin/Granulocyte Colony-Stimulating Factor Fusion Protein for Injection to Prevent Neutrophilic Granulocytopenia Among Chemotherapy Patients

The purpose of this study is to evaluate the dosages of recombinant human serum albumin/granulocyte colony-stimulating factor fusion protein by injection for preventing neutrophilic granulocytopenia among chemotherapy patients.

Conduct Pharmacokinetics (PK) study on recombinant human serum albumin/granulocyte colony-stimulating factor fusion protein with recombinant human granulocyte colony-stimulating factor injection as a control.

Read the detailed description
  • Brief Protocol: Treat the patients taking Taxotere+Epirubicin+Cyclophosphamide (TEC) treatment or Taxotere+Epirubicin (TE) treatment chemotherapy with the study medicine or positive control during the period between two chemotherapy treatments.
  • Positive control：recombinant human granulocyte colony-stimulating factor injection.
  • Targeted patients: breast cancer
  • Grouping: Group 1: 1.2 mg recombinant human serum albumin/granulocyte colony-stimulating factor fusion protein with TEC or TE treatment; Group 2: 1.5 mg recombinant human serum albumin/granulocyte colony-stimulating factor fusion protein with TEC or TE treatment; Group 3: positive control with TEC or TE treatment.
  • Number of patients: 216
  • Concomitant medicines will be conducted.
Being tested
HSA-GCSF 1.2 mg, HSA-GCSF 1.5 mg, GCSF

What participants receive

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

  • HSA-GCSF 1.2 mgDrug

    Human Serum Albumin GCSF 1.2mg at day 3 and Day 7

  • HSA-GCSF 1.5 mgDrug

    Human Serum Albumin GCSF 1.5 mg at day 3 and Day 7

  • GCSFDrug

    GCSF 5 mcg/kg/day

Study groups in NCT02465801
Study groupRoleWhat they receive
Group 1ExperimentalIntervention: HSA-GCSF 1.2 mg Drug: TE or TEC TE: Taxotere+Epirubicin Taxotere (75mg/m2) and Epirubicin (75mg/m2), IV on day 1 of each 21 chemotherapy cycle. TEC:Taxotere+Epirubicin+Cyclophosphamide Taxotere (75mg/m2),Epirubicin (75mg/m2) and Cyclophosphamide (500mg/m2), IV on day 1 of each 21 chemotherapy cycle. Recombinant Human Serum Albumin/Granulocyte Colony-Stimulating Factor Fusion Protein（1.2mg）will be injected subcutaneously at night o'clock a.m. in the 3rd and 7th day of per chemotherapy cycle. After the injection, stop administrating if Absolute Neutrophil Count (ANC) in peripheral blood exceeded 1.5×109/L at two contiguous times at least. If not up to standard, investigator should decide whether or not the third administration.
Receives: Drug: HSA-GCSF 1.2 mg
Group 2ExperimentalIntervention:HSA-GCSF 1.5 mg Drug: TE or TEC TE: Taxotere+Epirubicin Taxotere (75mg/m2) and Epirubicin (75mg/m2), IV on day 1 of each 21 chemotherapy cycle. TEC:Taxotere+Epirubicin+Cyclophosphamide Taxotere (75mg/m2),Epirubicin (75mg/m2) and Cyclophosphamide (500mg/m2), IV on day 1 of each 21 chemotherapy cycle. Recombinant Human Serum Albumin/Granulocyte Colony-Stimulating Factor Fusion Protein（1.5mg）will be injected subcutaneously at night o'clock a.m. in the 3rd and 7th day of per chemotherapy cycle. After the injection, stop administrating if Absolute Neutrophil Count (ANC) in peripheral blood exceeded 1.5×109/L at two contiguous times at least. If not up to standard, investigator should decide whether or not the third administration. Intervention: Drug: TE or TEC
Receives: Drug: HSA-GCSF 1.5 mg
Group 3Active comparatorIntervention: GCSF Drug: TE or TEC TE: Taxotere+Epirubicin Taxotere (75mg/m2) and Epirubicin (75mg/m2), IV on day 1 of each 21 chemotherapy cycle. TEC:Taxotere+Epirubicin+Cyclophosphamide Taxotere (75mg/m2),Epirubicin (75mg/m2) and Cyclophosphamide (500mg/m2), IV on day 1 of each 21 chemotherapy cycle. Recombinant Human Granulocyte Colony-Stimulating Factor Injection (5μg/kg/day) will be injected subcutaneously at night o'clock a.m. from the 3rd of per chemotherapy cycle. After the injection, stop administrating if Absolute Neutrophil Count (ANC) in peripheral blood exceeded 1.5×109/L at two contiguous times at least. The maximum of usage was continuous 14 days. Intervention: Drug: TE or TEC
Receives: Drug: GCSF

What is being measured

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

  1. The mean of duration for class IV neutrophilic granulocytopenia

    Measured: 4 weeks

Secondary outcomes (5)

  1. The mean of duration for class IV neutrophilic granulocytopenia

    Measured: 8 weeks

  2. The mean of duration for ANC up to 2.0×109/L

    Measured: 8 weeks

  3. ANC

    Measured: 8 weeks

  4. The usage of antibiotics

    Measured: 8 weeks

  5. febrile neutropenia

    Measured: 8 weeks

Timeline

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

  1. First posted8 Jun 2015 (estimated)
  2. Study start16 Dec 2014
  3. Primary completion23 Dec 2015
  4. Study completion26 Apr 2016

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
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
216 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02465801
Sponsor's protocol ID
RG01N-0778
Status last verified
Nov 2014
First submitted
17 Nov 2014
Last updated
18 Jul 2017
Results posted
No
Data monitoring committee
No

Publications

  • Chen S, Han Y, Ouyang Q, Lu J, Zhang Q, Yang S, Wang J, Huang H, Liu H, Shao Z, Li H, Chen Z, Sun S, Geng C, Lu J, Sun J, Wang J, Xu B. Randomized and dose-escalation trials of recombinant human serum albumin /granulocyte colony-stimulating factor in patients with breast cancer receiving anthracycline-containing chemotherapy. BMC Cancer. 2021 Mar 31;21(1):341. doi: 10.1186/s12885-021-08093-z.

    PubMed 33789616

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HSA-GCSF 1.2 mg, HSA-GCSF 1.5 mg and GCSF in people with Chemotherapy-induced Neutropenia, run by Tianjin SinoBiotech Ltd. at 1 site in China.

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 9 inclusion and 11 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 18 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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 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.

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?

The mean of duration for class IV neutrophilic granulocytopenia (time frame: 4 weeks). 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 NCT02465801, which also lists 1 linked publication.

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 18 Jul 2017.

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