EUCTR2007-004671-19-FR进行中（未招募）不适用
A Phase 2, Single-Arm Study of Pralatrexate in Patients with Advancedor Metastatic Relapsed Transitional Cell Carcinoma of the Urinary Bladder
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
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
- All
入选标准
- •1. Histologically confirmed TCC (> 50% TCC in tumor) of the urinary bladder. Fine needle aspirate will not be accepted.
- •2. Relapsed after treatment with no more than 1 platinum-based systemic chemotherapy regimen for metastatic disease or relapsed within 6 months of previous platinum-based neoadjuvant/adjuvant therapy. Patient has recovered from the toxic effects of prior therapy. Previous intravesical therapy is allowed. Prior surgical resection is allowed, as long as the patient has recovered.
- •3. Measurable disease, outside a previously irradiated region, per Response Evaluation Criteria in Solid Tumors (RECIST).
- •4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •5. = 18 years of age.
- •6. Adequate hematologic, hepatic, and renal function as defined by: Hgb = 10 g/dL (= 100 g/L); WBC count = 2500 cells/mm3 (= 2.5 x 109 cells/L); absolute neutrophil count (ANC)= 1500 cells/mm3 (= 1.5 x 109 cells/L); platelet count = 100,000/mm3; calculated CrCl of = 50 mL/min; total bilirubin = 1.5 x upper limit of normal (ULN); and aspartate aminotransferase (AST, serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT, serum glutamic-pyruvic transaminase [SGPT]) = 3 x ULN.
- •7. The patient has been on a regimen of 1-1.25 mg PO QD of folic acid for at least 7 days prior to enrollment and has received 1 mg IM of vitamin B12 within 10 weeks of enrollment.
- •8. Women of childbearing potential have a negative serum pregnancy test within 14 days prior to enrollment and must agree to practice a medically acceptable 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.
- •9. Men who are not surgically sterile and whose partner is of childbearing potential must be practicing a medically safe and effective contraceptive regimen from the time of pralatrexate initiation, and agree to continue practicing until at least 90 days after the last administration of pralatrexate.
- •10. Accessible for repeat dosing and follow-up.
- •11. 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. Active concurrent primary malignancy (except non-melanoma skin cancer, in situ carcinoma of the cervix, or occult, indolent carcinoma of the prostate [undetectable prostate-specific antigen, Gleason score = 7, no seminal vesicle invasion, and no extraprostatic extension]). If there is a history of prior malignancy, the patient must be disease-free for = 5 years. In the case of a single extrapelvic metastatic site, irrespective of the patient having a history of previous malignancy, a biopsy proof of the metastatic diseased organ will be necessary.
- •2. More than one previous regimen for either neoadjuvant/adjuvant or advanced disease (except simultaneous chemoradiotherapy).
- •3. Evidence of clinically significant active thirdspace phenomenon; ie, peripheral edema (= +2), active pleural effusions, or ascites.
- •4. Use of any investigational drugs, biologics, or devices within 28 days prior to study
- •enrollment.
- •5. Previous exposure to other antifolates (eg, methotrexate, pemetrexed [Alimta]). Previous methotrexate is allowed, only if it was part of a M-VAC or MCV regimen and provided that 6 months has elapsed since treatment with M-VAC or MCV.
- •6. Previous exposure to pralatrexate.
- •7. Women who are pregnant or breastfeeding.
- •8. Congestive Heart Failure Class III/IV according to New York Heart Association (NYHA) Functional Classification.
- •9. Uncontrolled hypertension.
- •10. Known human immunodeficiency virus (HIV)-positive status.
- •11. CNS metastatic disease.
- •12. Major surgery within 2 weeks of study enrollment.
- •13. Receipt of any conventional systemic chemotherapy or RT within 4 weeks (6 weeks for nitrosoureas, mitomycin C) prior to study enrollment.
- •14. Active infection or any serious underlying medical condition, which would impair the ability of the patient to receive protocol treatment.
- •15. Dementia or significantly altered mental status that would prohibit the understanding and giving of IC or limit study compliance.
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