EUCTR2008-005578-12-GB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 or Locally Advanced Cervical Cancer
ektar Therapeutics0 个研究点目标入组 70 人开始时间: 2009年4月28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
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 cervical cancer
- •4)Inoperable metastatic or locally advanced disease
- •5)Patients must not have received prior chemotherapy given in the metastatic / locally advanced setting; one prior concomitant chemotherapy regimen is permissible provided it did not include a camptothecin
- •6)Measurable disease as defined by RECIST 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 GCSF support for 21 days preceding the lab assessment
- •b White blood cell (WBC) count = 3,000/mm3 without GCSF 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 within 7 days preceding the lab assessment
- •e Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) = 3 × upper limit of normal (ULN) (= 5 × ULN if the presence of liver metastasis is confirmed). Bilirubin must be within normal limits.
- •f Serum creatinine = 1.5 times ULN or creatinine clearance = 60 mL/min
- •g Albumin = 3 g/dL (30 g/L)
- •9)Patients who are women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at the predose visit of each cycle
- •10)Patients who are 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 by the male partner, during the treatment period and for at least 3 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
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 CTC Grade 1 toxicity (any CTC 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) inducer or inhibitor: 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 who have been treated with an investigational agent within 4 weeks prior to Day 1 of Cycle 1
- •5)Prior treatment with a camptothecin
- •6)Concomitant use of biological agents including growth factors
- •7)Known or suspected central nervous system metastases
- •8)Pregnant or lactating
- •9)Other malignancy within the past 3 years except for any of the following: non-melanoma skin cancer, or any another malignancy with no evidence of recurrence for more than 5 years
- •10)Any other significant co-morbid conditions that in the opinion of the Investigator would impair study participation or cooperation
- •11)Patients with a history of hypersensitivity to other PEGylated drugs
- •12)Patients with inflammatory bowel disease
- •13)Patients with unresolved bowel disease
研究者
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