Phase 3 Study to Evaluate the Safety and Efficacy of YPEG-rhG-CSF in Malignancies Receiving Chemotherapy

Xiamen Amoytop Biotech

Status and phase: Completed; Phase 3

Conditions: Non-Myeloid Malignancy

Treatments: Drug: rhG-CSF/PEG-rhG-CSF; Drug: YPEG-rhG-CSF

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04466137

TB1801CSF

Details and patient eligibility

About

This phase 3 study is aimed to evaluate the safety and efficacy of YPEG-rhG-CSF in reducing the infection manifested by febrile neutropenia in patients with non-myeloid malignancy who receiving Myelosuppressive Chemotherapy which is likely to cause clinically significant febrile neutropenia.

Enrollment: 398 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histopathology and/or cytology diagnosed as breast cancer (BC) or non-small cell lung cancer (NSCLC), and patients with breast cancer is suitable to receive TAC(Docetaxel,Doxorubicin combined with Cyclophosphamide) chemotherapy, while patients with NSCLC is suitable to receive DC(Docetaxel combined with Carboplatin) chemotherapy.
• Age ≥18 yrs.
• Weight ≥45 kg.
• Karnofsky Score ≥ 70.
• Life Expectancy ≥ 3 months.
• Peripheral blood test: WBC≥3.5×10^9 cells/L, PLT≥100×10^9 cells/L. ANC≥1.5×10^9 cells/L.
• Understand and voluntarily sign the informed consent form.

Exclusion criteria

• Receiving chemotherapy within two months prior to screening.
• Previously or plan to receive radiotherapy (>25% total bone marrow volume).
• Evidence of tumor metastasis in bone marrow.
• Lack of awareness.
• Uncontrolled infection or using of antibiotics within 72hrs prior to screening.
• Previously received or plan to undergoing bone marrow or organ transplants.
• Patients with bleeding tendency, e.g. prolonged prothrombin time of more than 3 seconds.
• Dysfunction in heart,lung, liver, kidney, or other major organs or systems; ALT>2.5 ULN (upper limit of normal), TBil >2.5 ULN (ALT>2.5 ULN, total bilirubin >2.5 ULN for patients with liver metastasis), HBsAg positive, anti-HCV positive, evidence of liver decompensation, or Cr >1.5 ULN.
• Pregnant or lactating females.
• Malignancy other than BC or NSCLC.
• Hypersensitivity to rhG-CSF or any component of the investigational Products.
• Subject enrolled in any other studies within 3 months prior to screening.
• Drug abuser or alcoholics.
• Any other conditions which in the opinion of the investigator precluded enrollment into the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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398 participants in 3 patient groups

YPEG-rhG-CSF 2mg

Experimental group

Description:

YPEG-rhG-CSF 2mg

Treatment:

Drug: YPEG-rhG-CSF

Drug: YPEG-rhG-CSF

YPEG-rhG-CSF 33μg/kg

Experimental group

Description:

YPEG-rhG-CSF 33μg/kg

Treatment:

Drug: YPEG-rhG-CSF

Drug: YPEG-rhG-CSF

Positive Control Group

Active Comparator group

Description:

rhG-CSF/PEG-rhG-CSF

Treatment:

Drug: rhG-CSF/PEG-rhG-CSF