EUCTR2008-004128-22-GB进行中（未招募）不适用
An exploratory study to evaluate the biological activity of R1507, a human monoclonal antibody, antagonist of the insulin-like growth factor receptor (IGF-1R) in women with operable breast cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
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. Female only
- •2. Age = 18 years
- •3. Able to comply with the protocol
- •4. Histological diagnosis of invasive breast cancer
- •5. Operable breast cancer
- •6. Availability of liquid nitrogen-stored breast tissue samples from the breast cancer diagnostic biopsy
- •7. Written informed consent (Informed Consent document to be approved by the institution’s Independent Ethics committee [IEC]) for study participation including use of diagnostic breast lesion biopsy and excised tissue at definitive breast surgery, obtained from all subjects prior to any study specific screening
- •8. ECOG Performance Status of 0 or 1
- •9. Life expectancy >4 months
- •10. INR = 1.5 and APTT = 1.5 x ULN for the reference lab
- •11. Adequate bone marrow function as evidenced by:
- •- ANC =1500/mm3
- •- Platelet count = 100,000/mm3
- •- Hemoglobin = 9.0 g/dL (after transfusion, if needed)
- •12. Adequate renal function as evidenced by serum creatinine =1.5 x ULN for the reference lab
- •13. Adequate hepatic function as evidenced by:
- •- Serum albumin = 2.5 mg/dL
- •- Serum total bilirubin =2.0 mg/dL
- •- ALT/AST= 2.5 x ULN for the reference lab
- •- Alkaline phosphatase =2.5 x ULN for the reference lab
- •14. HbA1c = 7%
- •15. Negative pregnancy test within 7 days of starting study treatment in pre-menopausal women and women < 2 years after the onset of menopause
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Evidence of metastatic disease
- •2. Prior hormonal or systemic therapy for breast cancer
- •3. Prior treatment with an agent targeting the IGF-1R pathway
- •4. Inflammatory breast cancer
- •5. Patients with history of organ (including bone marrow) transplantation
- •6. Major surgical procedure or significant traumatic injury within 14 days prior to start of study treatment
- •7. Patients who have known hypersensitivity to any of the components of R1507 or who have had prior hypersensitivity reactions to monoclonal antibodies
- •8. Patients who have received investigational agent therapy within 30 days or a period of 5 half-lives (whichever is longer) of the investigational agent therapy in question (or longer, at the discretion of the investigator) prior to the first scheduled day of dosing (investigational agent therapy is defined as treatment for which there is currently no regulatory authority approved indication)
- •9. Patients who are receiving concurrent radiotherapy or who have received radiotherapy for current active disease.
- •10. Patients who are receiving concurrent antibody or immunotherapy (i.e., interferon-alpha, interferon-beta, interleukin-2, etanercept, infliximab, tacrolimus, cyclosporine, mycophenolic acid, alefacept, or efalizumab) or have received antibody or immunotherapy within 4 weeks prior to receipt of study drug
- •11. Administration of high doses of systemic corticosteroids High dose is considered as > 20 mg of dexamethasone a day (or equivalent) for > 7 consecutive days
- •12. Patients who are receiving concurrent warfarin anticoagulant therapy
- •13. Any disease [including psychotic/mental disorders, drug abuse, active infection, uncontrolled hypertension, clinically significant cardiovascular disease [for example CVA (= 6 months before the start of treatment), myocardial infarction (= 6 months before the start of treatment), unstable angina, NYHA = Grade 2 CHF, unstable arrhythmia requiring medication], hepatic, renal or metabolic disease (including uncontrolled diabetes mellitus), metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contra-indicates the use of an investigational drug or puts the patient at high risk for treatment-related complications
- •14. Uncontrolled CNS disease (e.g., seizures not controlled with standard medical therapy)
- •15. Women of childbearing potential (WCBP) (<2 years after last menstruation) not using effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile)
- •16. Known HIV or Hepatitis B or C (active, previously treated or both)
研究者
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