EUCTR2009-014463-39-BG进行中（未招募）1 期
A Double-blind Randomised, Parallel Phase I/IIb Study to Evaluate Initial Safetyand Efficacy, Comparative Pharmacokinetics and Immunogenicity for CT-P6 andHerceptin in Metastatic Breast Cancer
Celltrion, Inc.0 个研究点目标入组 170 人开始时间: 2010年2月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 170
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Written and signed informed consent, obtained prior to starting any protocol-specific procedures.
- •2. Are females over 18 years of age.
- •3. Have pathologically confirmed, uni-dimensionally measurable metastatic breast
- •4. Have a strong Her-2 over-expression as described by a 3+ score by immunohistochemistry (IHC) or a positive fluorescence in-situ hybridisation (FISH) or chromogenic in-situ hybridisation (CISH) result.
- •5. Have target lesions outside prior radiation fields.
- •6. Have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- •7. Have at least 4 weeks since last surgery or radiation therapy, with full recovery.
- •Patients must have received no radiotherapy for the treatment of metastatic disease.
- •However, patients who have received adjuvant radiotherapy as part of the treatment of early breast cancer
- •are eligible if the last fraction of radiotherapy was administered at least 6 months prior to randomisation.
- •Radiotherapy administered
- •for the relief of metastatic bone pain other than the sole site of measurable diseases
- •is allowed, but:
- •o no more than 25% of marrow-bearing bone should have been irradiated,
- •o the last fraction of radiotherapy should not have been administered within
- •4 weeks prior to randomisation,
- •o patients must have recovered from all treatment-related toxicities prior to
- •randomisation.
- •8. Regarding trastuzumab treatment;
- •o Have never been treated with trastuzumab, or
- •o Prior trastuzumab and chemotherapy (taxane included) or trastuzumab alone as
- •neoadjuvant/adjuvant treatment is discontinued >12 months prior to randomisation.
- •9. Bisphosphonate therapy for bone metastases is allowed; however, treatment must be initiated prior to the first
- •dose of randomised therapy. Prophylactic use of
- •bisphosphonates in patients without bone diseases is not permitted, except for the
- •treatment of osteoporosis.
- •10. Laboratory requirements as defined below:
- •Haematology: Absolute neutrophil count (ANC): = 1,500/mm EXP 3 (1.5 x 10 EXP 9 cells/L); Platelets: =
- •100,000/mm EXP 3 (100 x 10 EXP 9 cells/L); Haemoglobin:
- •= 9.0 g/dL;
- •Liver function: Total bilirubin: = 1.5 x upper limit of normal (ULN); Aspartate aminotransferase (AST) and
- •alanine aminotransferase (ALT): = 2.5 x ULN, or = 5.0 x ULN in the case of liver metastasis;
- •Renal function: Serum creatinine: =2 mg/dL
- •11. Are expected to survive for at least 6 months.
- •12. Are not pregnant and do not plan to become pregnant during the study.
- •For females of childbearing potential, pregnancy tests must be performed via serum
- •pregnancy test at baseline (within 7 days prior to starting study drug) and at the end
- •of treatment. Further tests are only required if there is a suspicion of pregnancy. If
- •sexually active, must be using at least one reliable method of contraception (e.g., a
- •barrier method [condom or occlusive cap] with spermicidal
- •foam/gel/film/cream/suppository, an intrauterine device [IUD] or intrauterine
- •system [IUS], oral or injectable contraception, sterilisation of sole male partner,
- •abstinence) throughout the study period and for 6 months after the last study drug
- •Non-childbearing potential is defined as:
- •- aged =50 years and naturally amenorrhoeic for at least 1 year*, or
- •- premature ovarian failure confirmed by a specialist gynaecologist, or
- •- previous bilateral salpingo-oophorectomy or hysterectomy, or
- •- XY genotype, Turner’s syndrome, uterine agenesis.
- •* Amenorrhoea following cancer therapy does not rule out childbearing potential.
- •Are the tri
排除标准
- •1. Have received prior chemotherapy for metastatic breast cancer.
- •2. Current clinical or radiographic evidence of central nervous system (CNS)
- •metastases. A computerised tomography (CT) or magnetic resonance imaging
- •(MRI) scan of the brain is mandatory in cases of clinical suspicion of brain
- •metastases within 21 days of randomisation. Eligible patients must be
- •asymptomatic and cannot be receiving steroids.
- •3. Are receiving concurrent immunotherapy or hormonal therapy.
- •4. Have a history of congestive heart failure (CHF) of any New York Heart
- •Association (NYHA) criterion, or serious cardiac arrhythmia requiring treatment
- •(except for atrial fibrillation and/or paroxysmal supraventricular tachycardia).
- •5. Have an abnormal LVEF (=50%) at baseline, as determined by either
- •two-dimensional echocardiogram (ECHO) or multiple-gated acquisition (MUGA)
- •scan. If the patient is randomised, the same method of LVEF assessment, ECHO
- •or MUGA, must be used throughout the study.
- •6. History of myocardial infarction within 6 months before randomisation.
- •7. Current uncontrolled hypertension (systolic blood pressure >150 mmHg and/or
- •diastolic blood pressure >100 mmHg), or unstable angina.
- •8. Have severe dyspnoea at rest due to complications of advanced malignancy or
- •requiring supplementary oxygen therapy.
- •9. Have had a prior malignancy within the last 5 years that might affect breast
- •cancer diagnosis or assessment.
- •10. Have had prior mediastinal irradiation (except internal mammary-node irradiation
- •for the present breast cancer).
- •11. Have received cumulative doses of anthracycline exceeding 360 mg/m2 of body
- •surface area for doxorubicin, 720 mg/m2 for epirubicin, 120 mg/m2 for
- •mitoxantrone, 90 mg/m2 for idarubicin, or the equivalent of 360 mg/m2 of
- •doxorubicin for other anthracyclines such as liposomal doxorubicin. If more than
- •one anthracycline has been used, then the cumulative dose must not exceed the
- •equivalent of 360 mg/m2 of doxorubicin.
- •12. Have a history of hypersensitivity to the trastuzumab or to drugs with similar
- •chemical structures, or to any of the excipients, or to murine proteins.
- •13. Have a history of severe hypersensitivity reaction to paclitaxel, or to any of the
- •excipients.
- •14. Have peripheral neuropathy of grade 2 or greater
- •15. Have active or uncontrolled infection
- •16. Have any other medical or psychiatric condition that could compromise study
- •participation.
- •17. Have received treatment with any other investigational drug in the last 30 days
- •before study entry, or within less than five half-lives after receiving the previous
- •investigational drug.
- •18. Current known infection with human immunodeficiency virus (HIV), hepatitis B
- •virus (HBV) or hepatitis C virus (HCV).
- •19. Are pregnant or a nursing mother.
- •20. Have a history or suspicion of unreliability, poor cooperation or non-compliance
- •with medical treatment.
- •21. Have any concurrent disease or condition that, in the opinion of the investigator,
- •would make the patient unsuitable for participation in the study.
- •22. Have previously been randomosed in this study.
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