EUCTR2008-005577-36-BE进行中（未招募）1 期
A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Efficacy of NKTR-102 (PEG-Irinotecan) When Given on a Q14 Day or a Q21 Day Schedule in Patients with Metastatic Breast Cancer Whose Disease has Failed Prior Taxane-Based Treatment
ektar Therapeutics0 个研究点目标入组 70 人开始时间: 2009年1月22日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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
- All
入选标准
- •Each patient must meet the following criteria to be enrolled in this study:
- •1)Provide signed and dated informed consent prior to study-specific screening procedures
- •2)= 18 years old
- •3)Histologically or cytologically confirmed diagnosis of breast cancer
- •4)Inoperable metastatic disease
- •5)No more than two prior chemotherapy regimens given in the metastatic setting. Treatment must have included a taxane in the adjuvant or the metastatic setting. The patient may also have received chemotherapy in an adjuvant setting.
- •6)Measurable disease as defined by RECIST version 1.0 in at least one lesion not previously irradiated.
- •7)Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •8)Patients must have adequate organ and bone marrow function at the screening visit as defined below
- •a) Absolute neutrophil count = 1,500/mm3 without myeloid growth factor support for 21 days preceding the lab assessment
- •b) White blood cell (WBC) count = 3,000/mm3 without myeloid growth factor support for 21 days preceding the lab assessment
- •c) Platelet count = 100,000/mm3, without transfusion within 7 days preceding the lab assessment
- •d) Hemoglobin = 9 g/dL, without transfusion support
- •e) Total bilirubin = 2 mg/dL
- •f) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) = 3 × upper limit of normal (ULN) (= 5 × ULN if the presence of liver metastasis is confirmed).
- •g) Serum creatinine = 1.5 times ULN or creatinine clearance = 60 mL/min
- •9)Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at Cycle 1 Day 1
- •10)Women of childbearing potential, or men whose female partners are of childbearing potential, must agree to use at least 2 forms of contraception, 1 of which includes a barrier method (male condom) by the male partner, during the treatment period and for at least 8 months after the last dose of the study drug
- •11)Patients must be able and willing to comply with the study visit schedule and 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 57
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 13
排除标准
- •Patients who meet any of the following criteria will not be permitted entry to the study:
- •1)Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to Day 1 of Cycle 1, and must have, as determined by the Investigator, recovered to NCI-CTCAE Grade 1 toxicity (any NCI-CTCAE grade of alopecia is allowed) associated with previous treatments irrespective of the interval from the last treatment
- •2)Patients who have had any major surgery within 4 weeks prior to Day 1 of Cycle 1 or minor surgery within 2 weeks prior to Day 1 of Cycle 1
- •3)Administration of any of the following cytochrome P450 3A4 (CYP3A4) inducers or inhibitors: phenytoin, phenobarbital, carbamazepine, rifampin, rifabutin, St. John’s
- •Wort, ketoconazole, neuromuscular agents or atazanavir sulfate (Section 8.6.2) within
- •2 weeks prior to the first day of study drug treatment
- •4)Patients cannot have concomitant use of biologic agents including antibodies (e.g., bevacizumab, trastuzumab, etc.) as well as investigational agents.
- •5)Patients who have received any treatment with a camptothecin derivative (e.g., irinotecan, topotecan, SN-38 investigational agents, etc.).
- •6)Known or suspected central nervous system metastases
- •7)Pregnant or lactating
- •8)Other malignancy within the past 5 years except for any of the following: nonmelanoma skin cancer, carcinoma in situ of the cervix, or any another malignancy with no evidence of recurrence for more than 5 years. Patients with a history of lowgrade (Gleason score less than or equal to 6) localized prostate cancer will be eligible even if diagnosed less than 5 years previously.
- •9)Any other significant co-morbid conditions that in the opinion of the Investigator would impair study participation or cooperation
- •10)Patients with a history of hypersensitivity or intolerance to other PEGylated drugs
- •11)Patients with inflammatory bowel disease (e.g., Crohn’s disease and ulcerative colitis), unresolved bowel issues (e.g., diverticulitis, ileitis, colitis, complete bowel obstruction etc.) or patients with chronic or acute gastrointestinal disorders with diarrhea as a major symptom
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