NCT03246009

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2017

Completed
Last Updated

August 11, 2017

Status Verified

August 1, 2017

Enrollment Period

1.2 years

First QC Date

August 8, 2017

Last Update Submit

August 9, 2017

Conditions

Chemotherapy-induced NeutropeniaCancer, Breast

Keywords

NeutropeniaChemotherapyrHSA/GCSF

Outcome Measures

Primary Outcomes (1)

  • Number of adverse events

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

    14 days

Secondary Outcomes (1)

  • AUC

    14 days

Study Arms (6)

single injection-1.8mg

EXPERIMENTAL

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

Drug: rHSA/GCSF

single injection-2.1mg

EXPERIMENTAL

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

Drug: rHSA/GCSF

single injection-2.4mg

EXPERIMENTAL

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

Drug: rHSA/GCSF

multiple injection-1.8mg

EXPERIMENTAL

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-2.1mg

EXPERIMENTAL

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-2.4mg

EXPERIMENTAL

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

Drug: rHSA/GCSF

Interventions

rHSA/GCSFDRUG

single injection-1.8mg

single injection-1.8mg

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese Academy of Medical Sciences Cancer Hospital

Beijing, Beijing Municipality, 100021, China

Location

Related Publications (1)

  • 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.

    PMID: 33789616DERIVED

MeSH Terms

Conditions

Breast NeoplasmsNeutropenia

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte Disorders

Study Officials

  • Binghe XU, MD

    chinese academy of medical sciences tumor hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2017

First Posted

August 10, 2017

Study Start

January 21, 2016

Primary Completion

April 10, 2017

Study Completion

April 10, 2017

Last Updated

August 11, 2017

Record last verified: 2017-08

Locations

CN(1)