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Trial record 1 of 1 for:    NCT03246009
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Fusion Protein rHSA/GCSFclinical Study on Breast Cancer Patients

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ClinicalTrials.gov Identifier: NCT03246009
Recruitment Status : Completed
First Posted : August 10, 2017
Last Update Posted : August 11, 2017
Sponsor:
Information provided by (Responsible Party):
Tianjin SinoBiotech Ltd.

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


Condition or disease Intervention/treatment Phase
Chemotherapy-induced Neutropenia Cancer, Breast Drug: rHSA/GCSF Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 21, 2016
Actual Primary Completion Date : April 10, 2017
Actual Study Completion Date : April 10, 2017

Resource links provided by the National Library of Medicine


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

Experimental: single injection-2.1mg
rHSA/GCSF,injection,2.1mg,Single subcutaneous injection,Duration 1 day
Drug: rHSA/GCSF
single injection-2.1mg

Experimental: single injection-2.4mg
rHSA/GCSF,injection,2.4mg,Single subcutaneous injection,Duration 1 day
Drug: rHSA/GCSF
single 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
multiple injection-1.8mg

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
multiple injection-2.1mg

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
multiple injection-2.4mg




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. AUC [ Time Frame: 14 days ]
    AUC after single and multiple dose of rHSA/GCSF



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03246009


Locations
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China, Beijing
Chinese Academy of Medical Sciences Cancer Hospital
Beijing, Beijing, China, 100021
Sponsors and Collaborators
Tianjin SinoBiotech Ltd.
Investigators
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Principal Investigator: Binghe XU, MD chinese academy of medical sciences tumor hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tianjin SinoBiotech Ltd.
ClinicalTrials.gov Identifier: NCT03246009    
Other Study ID Numbers: RG01N-1399
First Posted: August 10, 2017    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tianjin SinoBiotech Ltd.:
Neutropenia
Chemotherapy
rHSA/GCSF
Additional relevant MeSH terms:
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Breast Neoplasms
Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs