Fusion Protein rHSA/GCSFclinical Study on Breast Cancer Patients

August 9, 2017 updated by: Tianjin SinoBiotech Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Chinese Academy of Medical Sciences Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: single injection-1.8mg
rHSA/GCSF,injection,1.8mg,Single subcutaneous injection,Duration 1 day
Drug: rHSA/GCSF
single injection-1.8mg
Drug: rHSA/GCSF
single injection-2.1mg
Drug: rHSA/GCSF
single injection-2.4mg
Drug: rHSA/GCSF
multiple injection-1.8mg
Drug: rHSA/GCSF
multiple injection-2.1mg
Drug: rHSA/GCSF
multiple injection-2.4mg
Experimental: single injection-2.1mg
rHSA/GCSF,injection,2.1mg,Single subcutaneous injection,Duration 1 day
Drug: rHSA/GCSF
single injection-1.8mg
Drug: rHSA/GCSF
single injection-2.1mg
Drug: rHSA/GCSF
single injection-2.4mg
Drug: rHSA/GCSF
multiple injection-1.8mg
Drug: rHSA/GCSF
multiple injection-2.1mg
Drug: rHSA/GCSF
multiple injection-2.4mg
Experimental: single injection-2.4mg
rHSA/GCSF,injection,2.4mg,Single subcutaneous injection,Duration 1 day
Drug: rHSA/GCSF
single injection-1.8mg
Drug: rHSA/GCSF
single injection-2.1mg
Drug: rHSA/GCSF
single injection-2.4mg
Drug: rHSA/GCSF
multiple injection-1.8mg
Drug: rHSA/GCSF
multiple injection-2.1mg
Drug: rHSA/GCSF
multiple injection-2.4mg
Experimental: multiple injection-1.8mg
rHSA/GCSF,injection,1.8mg, subcutaneous injection,Duration 4 day,A total of 2 injections, each interval of 3 days.
Drug: rHSA/GCSF
single injection-1.8mg
Drug: rHSA/GCSF
single injection-2.1mg
Drug: rHSA/GCSF
single injection-2.4mg
Drug: rHSA/GCSF
multiple injection-1.8mg
Drug: rHSA/GCSF
multiple injection-2.1mg
Drug: rHSA/GCSF
multiple injection-2.4mg
Experimental: multiple injection-2.1mg
rHSA/GCSF,injection,2.1mg, subcutaneous injection,Duration 4 day,A total of 2 injections, each interval of 3 days.
Drug: rHSA/GCSF
single injection-1.8mg
Drug: rHSA/GCSF
single injection-2.1mg
Drug: rHSA/GCSF
single injection-2.4mg
Drug: rHSA/GCSF
multiple injection-1.8mg
Drug: rHSA/GCSF
multiple injection-2.1mg
Drug: rHSA/GCSF
multiple injection-2.4mg
Experimental: multiple injection-2.4mg
rHSA/GCSF,injection,2.4mg, subcutaneous injection,Duration 4 day,A total of 2 injections, each interval of 3 days.
Drug: rHSA/GCSF
single injection-1.8mg
Drug: rHSA/GCSF
single injection-2.1mg
Drug: rHSA/GCSF
single injection-2.4mg
Drug: rHSA/GCSF
multiple injection-1.8mg
Drug: rHSA/GCSF
multiple injection-2.1mg
Drug: rHSA/GCSF
multiple injection-2.4mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of adverse events
Time Frame: 14 days
Number of participants with AE as a measure for safety and tolerability after single and multiple dose of rHSA/GCSF
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC
Time Frame: 14 days
AUC after single and multiple dose of rHSA/GCSF
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin SinoBiotech Ltd.

Investigators

  • Principal Investigator: Binghe XU, MD, Chinese Academy of Medical Sciences Tumor Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2016

Primary Completion (Actual)

April 10, 2017

Study Completion (Actual)

April 10, 2017

Study Registration Dates

First Submitted

August 8, 2017

First Submitted That Met QC Criteria

August 8, 2017

First Posted (Actual)

August 10, 2017

Study Record Updates

Last Update Posted (Actual)

August 11, 2017

Last Update Submitted That Met QC Criteria

August 9, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG01N-1399

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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