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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

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

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

NCT ID

NCT03246009

First Posted

August 8, 2017

Last Updated

August 9, 2017

Sponsor

Tianjin SinoBiotech Ltd.

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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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