JPRN-jRCT2080225037已完成1 期
A Phase I Clinical Trial on the safety of KRN125 in breast cancer patients
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
研究概览
简要总结
This study was conducted in breast cancer patients to evaluate the safety of pegfilgrastim administered subcutaneously via the OBI. No serious adverse events or febrile neutropenia occurred, and no safety concerns associated with OBI function arose. For outpatients requiring pegfilgrastim following cancer chemotherapy, the use of an OBI was considered to be a safe option to reduce the need for outpatient visits that restrict their activities of daily living.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 70age old（—）
- 性别
- Female
入选标准
- •1) Written informed consent must be obtained prior to performing any study-related procedure
- •2) Japanese women aged 20 to <70 years at the time of informed consent
- •3) Patients diagnosed with primary invasive breast cancer
- •4) In the women of childbearing potential*, patients who agreed to use highly effective methods of contraception from the time of obtaining informed consent to 6 months after completion of administration of the investigational drug. Women of childbearing potential should have a negative pretest serum pregnancy test result
- •* Women of childbearing potential do not include women who have undergone permanent contraception, postmenopausal women (if no menstruation occurs for at least 12 months without another medical reason), or women who are not anatomically of childbearing potential.
排除标准
- •1) Patients who received cancer chemotherapy in the past
- •2) Patients with a ECOG PS of 2 or greater
- •3) Patients who meet any of the following conditions as a result of preliminary examination (examination within 3 months before the date of registration including before obtaining informed consent) and have active hepatitis B infection
- •- HBsAg positive
- •- Positive for HBc antibody and/or HBs antibody and positive for HBV-DNA
- •Patients who are actively antibody-positive due to hepatitis B vaccination and who are not affected by hepatitis B at the time of the screening test do not require HBV-DNA determination and can be enrolled in this study.
- •4) Patients who were positive for HCV antibody as a result of preliminary examination (examination within 3 months before the date of enrollment including before obtaining informed consent) and confirmed to be infected with HCV by RNA or other tests
- •5) Patients with HIV infection or HIV antibody positive as a result of a preliminary examination (examination within 3 months before the date of enrollment including before obtaining informed consent is acceptable). Patients with acquired, unclassifiable or hereditary, primary or secondary immunodeficiency
- •6) Patients with significant complications or a history of such complications that are judged by the principal investigator or the subinvestigator to affect the conduct and evaluation of the study. Including, but not limited to, the following. Severe cardiovascular disease (e.g. New York Heart Association functional class includes vascular lesions requiring inpatient treatment such as congestive heart failure or myocardial infarction with class III or IV), uncontrolled hypertension, poorly controlled diabetes mellitus (>=HbA1c 9%), and hepatic diseases (e.g. Class B or C according to Child-Pugh category), renal disease, respiratory disease, hematologic disease, central nervous system disease, psychiatric disease, autoimmune disease, etc.
- •7) Patients with infections that may become severe after participation in the study.
- •8) Patients who received radiation therapy within 28 days before obtaining informed consent
- •9) Patients with a history of onset or treatment of malignancy other than the primary disease within 5 years before obtaining informed consent (excluding curatively treated cervical carcinoma in situ, basal cell carcinoma of the skin, and squamous cell carcinoma of the skin)
- •10) Patients who developed cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.) requiring hospitalization within 6 months before obtaining informed consent
- •11) Patients who have received biologics (including the investigational drug) within 16 weeks before obtaining informed consent or within 5 times the half-life (whichever is longer).
- •12) Patients who have participated in a clinical trial or an equivalent clinical trial of a drug and have received administration of an investigational product (excluding biological products) or use of an unapproved medical device within 16 weeks before obtaining informed consent or within 5 times the half-life (whichever is longer).
- •13) Patients who have received KRN125 (dilastic)
- •14) Patients who have received G-CSF products within 14 days prior to obtaining informed consent
- •15) Patients with a history of significant immune reactions (serologic sickness, anaphylaxis, anaphylactoid reaction) to other biological agents or to any excipient of KRN125 (dilasta)
- •16) Patients with a history of alcohol or drug abuse within 1 year b
研究者
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