Clinical trial NCT04466137: Phase 3 Study to Evaluate the Safety and Efficacy of YPEG-rhG-CSF in Malignancies Receiving Chemotherapy
Official title: A Multi-centers, Randomized, Open-labeled, Positive-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of YPEG-rhG-CSF, Once-per-cycle, in Patients With Malignancies Receiving Myelosuppressive Chemotherapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Myeloid Malignancy
Keywords: G-CSF
Human Granulocyte Colony-Stimulating Factor
Febrile Neutropenia
Neutropenia
Myelosuppressive Chemotherapy
FN
Lead sponsor: Xiamen Amoytop Biotech Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
First posted: 2020-07-10
Enrollment: 398
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean Duration of Severe Neutropenia (DSN) During Cycle 1.
timeFrame: At the end of Cycle 1 (21 days one cycle)
Secondary outcomes:
measure: Incidence of Febrile neutropenia(FN).
timeFrame: Cycle1 to Cycle 4(21 days one cycle)
measure: Mean duration of DSN.
timeFrame: Cycle2 to Cycle 4 (21 days one cycle)
measure: Incidence of Grade 3 neutropenia.
timeFrame: Cycle1 to Cycle 4 ( 21 days one cycle)
measure: Mean duration of grade 3 neutropenia.
timeFrame: Cycle1 to Cycle 4(21 days one cycle)
measure: Neutrophils dynamic changes from baseline.
timeFrame: Cycle1 to Cycle 4 ( 21 days one cycle)
measure: Time of neutrophils recovering to over 2.0×10^9 cells/L after nadir.
timeFrame: Cycle1 to Cycle 4 (21 days one cycle)
measure: Proportion of patients with antibiotic usage.
timeFrame: Cycle1 to Cycle 4 ( 21 days one cycle)
measure: Proportion of patients experienced infection.
timeFrame: Cycle1 to Cycle 4 ( 21 days one cycle)
measure: Proportion of patients fulfilling expected chemotherapy.
timeFrame: Cycle1 to Cycle 4 (21 days one cycle)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
Study officials:
References: