EUCTR2008-006425-14-FR进行中（未招募）不适用
Phase 1/2 Study of Pralatrexate in Female Patients with Previously-treated Advanced or Metastatic Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 78
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
- •Inclusion Criteria:
- •1. Histologically and/or cytologically confirmed human epidermal growth factor receptor 2 (HER-2) negative advanced or metastatic breast cancer, as shown by fluorescence in situ hybridization (FISH) or immunohistochemistry (IHC).
- •2. Patients must have failed at least 1 prior chemotherapy regimen for advanced or metastatic disease.
- •3. Patients with advanced or metastatic disease resistant to both a taxane and an anthracycline-containing chemotherapy regimen or resistant to taxanes and for whom further anthracycline therapy is not indicated. Taxane resistance is defined as progressive disease while on or within 3 months from end of treatment, with or without an initial response, or relapse within 6 months of completing treatment with an anthracycline-containing adjuvant regimen.
- •4. Patients with controlled brain metastases must have completed appropriate radiation therapy and if on corticosteroids, be on a stable or tapering dose for at least 28 days prior to study entry.
- •5. Measurable disease according to the Response Evaluation Criteria In Solid Tumors (RECIST): at least 1 uni-dimensionally measurable non-bony target lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) or chest x-ray (= 20 mm with conventional techniques or = 10 mm with spiral CT scan) outside a previously radiated field.
- •6. Female = 18 years of age.
- •7. Eastern Cooperative Oncology Group (ECOG) performance status = 2.
- •8. Life expectancy > 3 months.
- •9. Adequate hematological, hepatic, and renal function as defined by: white blood cell (WBC) count = 2500 cells/µL (= 2.5 x 109 cells/L), absolute neutrophil count (ANC) = 1500 cells/µL (= 1.5 x 109 cells/L); platelet count = 100,000/µL (= 100 x 109/L); hemoglobin = 10 g/dL (= 100 g/L); calculated creatinine clearance (CrCl) of = 50 mL/min; total bilirubin = 1.5 x the upper limit of normal (ULN); aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT), alanine aminotransferase/serum glutamic-pyruvic transaminase (ALT/SGPT), and gamma-glutamyltransferase (?-GT) = 3 x ULN (if clearly attributable to liver metastases, ALT/AST/?-GT = 5 x ULN is permitted).
- •10. Females of childbearing potential have a negative serum pregnancy test within 14 days prior to enrollment and must agree to practice a medically acceptable and effective contraceptive regimen from enrollment until at least 30 days after the last administration of pralatrexate. Patients who are postmenopausal for at least 1 year (> 12 months since last menses) or are surgically sterilized do not require this test.
- •11. Accessible for repeat dosing and follow- up.
- •12. Given written informed consent (IC).
- •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. Patients with bone metastasis only.
- •2. A single metastatic site without histological proof of the lesion being metastatic breast cancer.
- •3. Patients with inflammatory breast cancer.
- •4. Receipt of systemic chemotherapy, hormone therapy, radiation therapy, or other investigational therapy within 3 weeks (6 weeks for nitrosoureas, mitomycin C) prior to enrollment, with the following exceptions noted:
- •Bisphosphonates are permitted if ongoing.
- •Phase 1 only: prior treatment with capecitabine, 5-fluorouracil (5-FU), or antifolates other than methotratrexate is excluded within 6 months prior to enrollment.
- •Prior treatment with methotrexate is excluded.
- •Prior treatment with anti-angiogenics is excluded within 6 months prior to enrollment.
- •5. Prior treatment with > 2 prior chemotherapy regimens (3 prior chemotherapy regimens are allowed if 1 of the treatments was neoadjuvant or adjuvant chemotherapy).
- •6. Previous exposure to pralatrexate.
- •7. Anthracycline maximum cumulative dose exceeded (ie, doxorubicin with no risk factors = 550 mg/m2, otherwise 450 mg/m2; epirubicin = 720 mg/m2).
- •8. Extensive prior radiation therapy on more than 30% of bone marrow reserve or prior bone marrow/stem cell transplantation.
- •9. Congestive Heart Failure Class III/IV according to New York Heart Association (NYHA) Functional Classification.
- •10. Uncontrolled hypertension.
- •11. Active infection or any serious underlying medical condition, which would impair the ability of the patient to receive protocol treatment.
- •12. Females who are pregnant or breastfeeding.
- •13. Major surgery within 14 days of enrollment.
- •14. Active concurrent primary malignancy (except adequately treated in situ cervical cancer and basal cell skin cancer).
- •15. Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent or limit study compliance.
- •16. Human immunodeficiency virus (HIV)-positive diagnosis.
- •17. Known active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
研究者
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