EUCTR2005-004941-33-DE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
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. 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. Patients whose tumors are Her-2-positive must have received prior trastuzumab therapy. 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 more than/or 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 less
- •than/equal to 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.
- •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]) less than/equal to 2.5 x laboratory
- •upper limit of normal (ULN). If liver function abnormalities are due to
- •underlying malignancy, then AST and ALT may be less than/equal to
- •5 x CL-ULN
- •Total serum bilirubin less than /equal to 1.5 x ULN
- •Prothrombin time (PT) and partial thromboplastin time (PTT) less
- •than /equal to 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 less than/equal to 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
- •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 (such as implants, injectables, combined oral contraceptives,
- •hormonal IUDs, sexual abstinence or vasectomised partner) to prevent
- •pregnancy during the study. All patients with reproductive potential must have
- •a negative pregnancy test prior to study treatment .
- •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.
- •13. History of myopathy.
研究者
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