Phase 3 Study to Evaluate the Safety and Efficacy of YPEG-rhG-CSF in Malignancies Receiving Chemo… (NCT04466137) | Clinical Trial Compass
CompletedPhase 3
Phase 3 Study to Evaluate the Safety and Efficacy of YPEG-rhG-CSF in Malignancies Receiving Chemotherapy
China398 participantsStarted 2020-10-16
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 in…
What they're measuring
1
Mean Duration of Severe Neutropenia (DSN) During Cycle 1.
Timeframe: At the end of Cycle 1 (21 days one cycle)