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Fusion Protein rHSA/GCSFclinical Study on Breast Cancer Patients

Primary Purpose

Chemotherapy-induced Neutropenia, Cancer, Breast

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
rHSA/GCSF
rHSA/GCSF
rHSA/GCSF
rHSA/GCSF
rHSA/GCSF
rHSA/GCSF
Sponsored by
Tianjin SinoBiotech Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chemotherapy-induced Neutropenia focused on measuring Neutropenia, Chemotherapy, rHSA/GCSF

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-65.
  • Diagnosed breast cancer,received chemotherapy.
  • ECOG performance status 0 or 1.
  • ANC≥1.5×10 9/L, PLT≥100×10 9/L. No bone marrow metastasis,blood coagulation function normally, no Hemorrhagic tendency.
  • Leukocyte reduction occurred after chemotherapy,WBC≤3.0x109/L or ANC≤1.5x109/L.
  • No obvious abnormal ecg examination.
  • Cr,TBIL, AST, ALT≤1.5×ULN,no serious underlying disease.
  • Signed informed consent.

Exclusion Criteria:

  • 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.
  • Allergic disease or allergic constitution. History of protein allergy.
  • History of drug addiction and alcoholism.
  • Hematopoietic stem cell transplantation or organ transplantation.
  • Received antibiotic treatment within 72 hours before chemotherapy.
  • Long-term use of hormones or immunosuppressive agents.
  • Severe mental or neurological disorders.
  • Chronic disease of severe cardiac, kidney and liver.
  • Other conditions that would be excluded from this study according to doctors'judgment.

Sites / Locations

  • Chinese Academy of Medical Sciences Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

single injection-1.8mg

single injection-2.1mg

single injection-2.4mg

multiple injection-1.8mg

multiple injection-2.1mg

multiple injection-2.4mg

Arm Description

rHSA/GCSF,injection,1.8mg,Single subcutaneous injection,Duration 1 day

rHSA/GCSF,injection,2.1mg,Single subcutaneous injection,Duration 1 day

rHSA/GCSF,injection,2.4mg,Single subcutaneous injection,Duration 1 day

rHSA/GCSF,injection,1.8mg, subcutaneous injection,Duration 4 day,A total of 2 injections, each interval of 3 days.

rHSA/GCSF,injection,2.1mg, subcutaneous injection,Duration 4 day,A total of 2 injections, each interval of 3 days.

rHSA/GCSF,injection,2.4mg, subcutaneous injection,Duration 4 day,A total of 2 injections, each interval of 3 days.

Outcomes

Primary Outcome Measures

Number of adverse events
Number of participants with AE as a measure for safety and tolerability after single and multiple dose of rHSA/GCSF

Secondary Outcome Measures

AUC
AUC after single and multiple dose of rHSA/GCSF

Full Information

First Posted
August 8, 2017
Last Updated
August 9, 2017
Sponsor
Tianjin SinoBiotech Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03246009
Brief Title
Fusion Protein rHSA/GCSFclinical Study on Breast Cancer Patients
Official Title
Efficacy and Safety Phase Ib Study of Recombinant Human Serum Albumin/ Granulocyte Colony-Stimulating Factor Fusion Protein for Injection to Prevent Neutrophilic Granulocytopenia Among Chemotherapy Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 21, 2016 (Actual)
Primary Completion Date
April 10, 2017 (Actual)
Study Completion Date
April 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin SinoBiotech Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the tolerance and safety of the rHSA/GCSF in breast cancer patients with different doses and multiple injections. To observe the pharmacokinetic characteristics of recombinant human serum albumin /granulocyte colony-stimulating factor fusion protein after single and multiple administration
Detailed Description
This experiment adopts the method of multicenter, open, dose escalation study injection with recombinant human blood clean protein/granulocyte stimulating factor fusion protein after single and multiple doses of tolerance, security, and pharmacokinetic characteristics. Breast cancer patients with reduced white blood cells after chemotherapy were selected as subjects of this study. The three research doses that were to be incremented were 1.8 mg, 2.1mg and 2.4mg respectively, each of which was studied by single and multiple doses. Single dose of medicine, dose-climbing study.Two doses of the drug, dose-climbing study

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Neutropenia, Cancer, Breast
Keywords
Neutropenia, Chemotherapy, rHSA/GCSF

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
single injection-1.8mg
Arm Type
Experimental
Arm Description
rHSA/GCSF,injection,1.8mg,Single subcutaneous injection,Duration 1 day
Arm Title
single injection-2.1mg
Arm Type
Experimental
Arm Description
rHSA/GCSF,injection,2.1mg,Single subcutaneous injection,Duration 1 day
Arm Title
single injection-2.4mg
Arm Type
Experimental
Arm Description
rHSA/GCSF,injection,2.4mg,Single subcutaneous injection,Duration 1 day
Arm Title
multiple injection-1.8mg
Arm Type
Experimental
Arm Description
rHSA/GCSF,injection,1.8mg, subcutaneous injection,Duration 4 day,A total of 2 injections, each interval of 3 days.
Arm Title
multiple injection-2.1mg
Arm Type
Experimental
Arm Description
rHSA/GCSF,injection,2.1mg, subcutaneous injection,Duration 4 day,A total of 2 injections, each interval of 3 days.
Arm Title
multiple injection-2.4mg
Arm Type
Experimental
Arm Description
rHSA/GCSF,injection,2.4mg, subcutaneous injection,Duration 4 day,A total of 2 injections, each interval of 3 days.
Intervention Type
Drug
Intervention Name(s)
rHSA/GCSF
Intervention Description
single injection-1.8mg
Intervention Type
Drug
Intervention Name(s)
rHSA/GCSF
Intervention Description
single injection-2.1mg
Intervention Type
Drug
Intervention Name(s)
rHSA/GCSF
Intervention Description
single injection-2.4mg
Intervention Type
Drug
Intervention Name(s)
rHSA/GCSF
Intervention Description
multiple injection-1.8mg
Intervention Type
Drug
Intervention Name(s)
rHSA/GCSF
Intervention Description
multiple injection-2.1mg
Intervention Type
Drug
Intervention Name(s)
rHSA/GCSF
Intervention Description
multiple injection-2.4mg
Primary Outcome Measure Information:
Title
Number of adverse events
Description
Number of participants with AE as a measure for safety and tolerability after single and multiple dose of rHSA/GCSF
Time Frame
14 days
Secondary Outcome Measure Information:
Title
AUC
Description
AUC after single and multiple dose of rHSA/GCSF
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-65. Diagnosed breast cancer,received chemotherapy. ECOG performance status 0 or 1. ANC≥1.5×10 9/L, PLT≥100×10 9/L. No bone marrow metastasis,blood coagulation function normally, no Hemorrhagic tendency. Leukocyte reduction occurred after chemotherapy,WBC≤3.0x109/L or ANC≤1.5x109/L. No obvious abnormal ecg examination. Cr,TBIL, AST, ALT≤1.5×ULN,no serious underlying disease. Signed informed consent. Exclusion Criteria: 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. Allergic disease or allergic constitution. History of protein allergy. History of drug addiction and alcoholism. Hematopoietic stem cell transplantation or organ transplantation. Received antibiotic treatment within 72 hours before chemotherapy. Long-term use of hormones or immunosuppressive agents. Severe mental or neurological disorders. Chronic disease of severe cardiac, kidney and liver. Other conditions that would be excluded from this study according to doctors'judgment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Binghe XU, MD
Organizational Affiliation
chinese academy of medical sciences tumor hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese Academy of Medical Sciences Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
33789616
Citation
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.
Results Reference
derived

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Fusion Protein rHSA/GCSFclinical Study on Breast Cancer Patients

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