EUCTR2005-003773-25-BE进行中（未招募）不适用
A PHASE 2 EFFICACY AND SAFETY STUDY OF SU011248 IN COMBINATION WITH TRASTUZUMAB AS TREATMENT FOR METASTATIC DISEASE IN PATIENTS WITH BREAST CANCER
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- PFIZER s.a.
- 入组人数
- 128
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. Histologically or cytologically proven diagnosis of breast cancer with evidence of
- •1) unresectable, locally recurrent, or 2) metastatic disease. Locally recurrent
- •disease must not be amenable to resection or radiation therapy with curative
- •2. Measurable disease as per Response Evaluation Criteria in Solid Tumors
- •(RECIST). Measurable lesions that have been previously radiated will not be
- •considered target lesions unless an increase in size is observed following
- •completion of radiation therapy.
- •3. HER2 positive disease (3+ by immunohistochemistry [IHC] or FISH-positive)
- •4. Candidate for treatment with trastuzumab. Prior treatment with trastuzumab
- •and/or lapatinib in the neoadjuvant, adjuvant or metastatic disease setting is
- •permitted. Treatment with hormone therapy in the adjuvant and/or advanced
- •disease setting is permitted
- •5. Inclusion criterion 5 deleted by Protocol Amendment 2.
- •6. Patients receiving bisphosphonate therapy for metastatic bone disease must
- •have initiated therapy at least 3 weeks prior to the first dose of study drug.
- •7. Female or male, 18 years of age or older.
- •8. ECOG performance status 0 or 1
- •9. Resolution of all acute toxic effects of prior therapy or surgical procedures to
- •grade less thaN/equal to 1 (except alopecia).
- •10. Adequate organ function as defined by the following criteria:
- •Serum aspartate transaminase (AST) and serum alanine transaminase
- •(ALT) = 2.5 x upper limit of normal (ULN), or AST and ALT less = 5 x ULN if liver
- •function abnormalities are due to underlying malignancy
- •Total serum bilirubin =1.5 x ULN
- •Serum albumin =3.0 g/dL
- •Absolute neutrophil count (ANC) =1500/microL
- •Platelets =100,000/microL
- •Hemoglobin =9.0 g/dL
- •Serum creatinine =to 1.5 x ULN
- •11. Signed and dated informed consent document indicating that the patient
- •(or legally acceptable representative) has been informed of all the pertinent
- •aspects of the trial prior to enrollment.
- •12. Willingness and ability to comply with scheduled visits, treatment plans,
- •laboratory tests, and other study procedures.
- •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. Exclusion criterion 1 deleted by Protocol Amendment 2.
- •2. Prior treatment with >1 regimen of cytotoxic therapy in the advanced disease
- •setting therapy is permitted. A regimen is defined as treatment until progression,
- •regardless of therapies included in that regimen prior to progression.
- •3. Exclusion criterion 3 deleted by Protocol Amendment 2.
- •4. Prior exposure to trastuzumab if the patient had developed severe
- •hypersensitivity reactions.
- •5. Exclusion criterion 5 deleted by Protocol Amendment 2.
- •6. Prior treatment on a SU011248 clinical trial.
- •7. Major surgery, radiation therapy, or systemic therapy within 3 weeks of first dose
- •of study treatment except palliative radiotherapy to non-target metastatic lesions.
- •8. Prior high-dose chemotherapy requiring hematopoietic stem cell rescue.
- •9. Prior radiation therapy to >25% of the bone marrow.
- •10. Current treatment on another clinical trial.
- •11. Exclusion criterion 11 deleted by Protocol Amendment 2.
- •12. Uncontrolled brain metastases, spinal cord compression, carcinomatous
- •meningitis, or leptomeningeal disease. Patients should have completed surgery
- •or radiation therapy for existing brain metastases, should not have documented
- •increase in size of lesions over the previous 3 months prior to the first dose of
- •study drug and should be asymptomatic.
- •13. Diagnosis of any second malignancy within the last 3 years, except for
- •adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of
- •the cervix.
- •14. Any of the following within the 12 months prior to starting study treatment:
- •myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
- •graft, congestive heart failure, cerebrovascular accident including transient
- •ischemic attack, or pulmonary embolus.
- •15. Ongoing cardiac dysrhythmias of NCI CTCAE grade =2, atrial fibrillation of any
- •grade, or QTc interval >450 msec for males or >470 msec for females.
- •16. Hypertension that cannot be controlled by medications (>150/100 mmHg
- •despite optimal medical therapy).
- •17. Current treatment with therapeutic doses of Coumadin (low dose Coumadin up
- •to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
- •18. Known human immunodeficiency virus infection.
- •19. Pregnancy or breastfeeding. All female patients with reproductive potential must
- •have a negative pregnancy test (serum or urine) prior to first dose of study
- •20. Other severe acute or chronic medical or psychiatric condition, or laboratory
- •abnormality that would impart, in the judgment of the investigator, excess risk
- •associated with study participation or study drug administration, or which, in the
- •judgment of the investigator, would make the patient inappropriate for entry
- •into this study.
研究者
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