EUCTR2005-004941-33-IT进行中（未招募）不适用
A Phase 2 Study of the Efficacy and Safety of SU-014813 in Patients with Metastatic Breast Cancer - ND
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- PFIZER
- 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. .Histologically or cytologically proven diagnosis of metastatic breast adenocarcinoma that is not amenable to surgery, radiation, or combined modality therapy with curative intent. 2. Must have received prior treatment with an anthracycline and a taxane either concurrently or sequentially in the adjuvant and/or advanced disease treatment settings. Patients may have received as many as 2 other chemotherapy regimens in the advanced disease setting. Prior hormonal therapy or immunotherapy in the adjuvant and/or advanced/metastatic disease settings is permitted. Prior treatment with surgery, radiotherapy, chemoembolization therapy, or cryotherapy is allowed if these therapies did not affect the areas of measurable disease. 3. If patient has only received treatment in the adjuvant setting, patient must have experienced relapse or progression of disease during treatment or within 12 months of the last dose of adjuvant therapy. 4. Completion of all prior chemotherapy, and radiotherapy / 3 weeks prior to study entry, and resolution of all acute toxic effects of any prior cytokine therapy, radiotherapy, or surgical procedure to National Cancer Institute NCI Common Terminology Criteria for Adverse Events version 3.0 grade / 1 5. Patients on bisphosphonate therapy for metastatic bone disease must have initiated therapy 3 months prior to study entry. 6. Evidence of unidimensionally measurable disease according to RECIST criteria. 7. Female 8. Eighteen years of age or older. 9. ECOG Eastern Cooperative Oncology Group performance status 0 or 1. 10. Adequate organ function as defined by the following criteria - Serum aspartate aminotransferase AST; serum glutamate-oxalate transferase SGOT and serum alanine aminotransferase ALT; serum glutamate-pyruvate transferase SGPT / 2.5 x laboratory upper limit of normal ULN . If liver function abnormalities are due to underlying malignancy, then AST and ALT may be /5 x CL-ULN - Total serum bilirubin / 1.5 x ULN - Prothrombin time PT and partial thromboplastin time PTT / 1.5 x ULN - Serum albumin / 3.0 g/dL -Absolute neutrophil count ANC / 1500 mm3 - Platelets / 100,000 mm3 - Hemoglobin / 9.0 g/dL - Serum creatinine / 1.5 x ULN 11. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. 12. Signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of he trial prior to enrollment.
- •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. Prior treatment with / 3 regimens of chemotherapy in the metastatic disease setting beyond those containing anthracyclines and taxanes. 2. Prior treatment with any tyrosine kinase inhibitors, VEGF inhibitors, or other angiogenic inhibitors. 3. Previous high-dose chemotherapy requiring hematopoietic stem cell rescue. 4. Prior radiation therapy to 25 of the bone marrow. 5. Current treatment on another clinical trial. 6. Uncontrolled brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease. Patients should have completed surgery or radiation therapy for existing brain metastases, should not have documented increase in size over the previous 3 months and should be asymptomatic. 7. Diagnosis of any second non-breast malignancy within the last 5 years, except for adequately treated basal cell carcinoma or for in situ carcinoma of the cervix uteri. 8. Any of the following within the 12 months prior to study drug administration severe/unstable angina, symptomatic congestive heart failure, or cerebrovascular accident including ischemic attack or pulmonary embolism. 9. Known human immunodeficiency virus HIV or acquired immunodeficiency syndrome AIDS -related illness. 10. Presence of malabsorption due to prior surgery, gastrointestinal disease or for an unknown reason, or inability to take oral medication. Patients may have had major GI surgery but must not have residual symptomatic manifestation of malabsorption. 11. Pregnancy or breast-feeding. Patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. All patients with reproductive potential must have a negative pregnancy test prior to study treatment . The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate. 12. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
研究者
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