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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02465801
Other study ID # RG01N-0778
Secondary ID
Status Completed
Phase Phase 2
First received November 17, 2014
Last updated July 16, 2017
Start date December 16, 2014
Est. completion date April 26, 2016

Study information

Verified date November 2014
Source Tianjin SinoBiotech Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the dosages of recombinant human serum albumin/granulocyte colony-stimulating factor fusion protein by injection for preventing neutrophilic granulocytopenia among chemotherapy patients.

Conduct Pharmacokinetics (PK) study on recombinant human serum albumin/granulocyte colony-stimulating factor fusion protein with recombinant human granulocyte colony-stimulating factor injection as a control.


Description:

- Brief Protocol: Treat the patients taking Taxotere+Epirubicin+Cyclophosphamide (TEC) treatment or Taxotere+Epirubicin (TE) treatment chemotherapy with the study medicine or positive control during the period between two chemotherapy treatments.

- Positive control:recombinant human granulocyte colony-stimulating factor injection.

- Targeted patients: breast cancer

- Grouping: Group 1: 1.2 mg recombinant human serum albumin/granulocyte colony-stimulating factor fusion protein with TEC or TE treatment; Group 2: 1.5 mg recombinant human serum albumin/granulocyte colony-stimulating factor fusion protein with TEC or TE treatment; Group 3: positive control with TEC or TE treatment.

- Number of patients: 216

- Concomitant medicines will be conducted.


Recruitment information / eligibility

Status Completed
Enrollment 216
Est. completion date April 26, 2016
Est. primary completion date December 23, 2015
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Age 18-65.

- Diagnosed breast cancer, suitable for TEC or TE .

- ECOG performance status 0 or 1.

- Adjuvant chemotherapy; new adjuvant chemotherapy; newly diagnosed class ? and prior chemotherapy.

- ANC=1.5×10 9/L, PLT=100×10 9/L. No bone marrow metastasis,blood coagulation function normally, no Hemorrhagic tendency.

- No obvious abnormal ecg examination.

- TBIL, ALT, AST=2.5×ULN (=5×ULN if presence of hepatic metastases).

- Cr, BUN=2.5×ULN.

- 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.

- Chronic disease of severe cardiac, kidney and liver.

- Other conditions that would be excluded from this study according to doctors'judgment

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
HSA-GCSF 1.2 mg
Human Serum Albumin GCSF 1.2mg at day 3 and Day 7
HSA-GCSF 1.5 mg
Human Serum Albumin GCSF 1.5 mg at day 3 and Day 7
GCSF
GCSF 5 mcg/kg/day

Locations

Country Name City State
China Cancer Hospital, Chinese Academy of Medical Scienses Beijing

Sponsors (1)

Lead Sponsor Collaborator
Tianjin SinoBiotech Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The mean of duration for class IV neutrophilic granulocytopenia 4 weeks
Secondary The mean of duration for class IV neutrophilic granulocytopenia 8 weeks
Secondary The mean of duration for ANC up to 2.0×109/L 8 weeks
Secondary ANC 8 weeks
Secondary The usage of antibiotics 8 weeks
Secondary febrile neutropenia 8 weeks
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