NL-OMON33657尚未招募不适用
An Open-Label Study to Investigate the Pharmacokinetics (Distribution, Metabolism, and Excretion) of Bendamustine Hydrochloride Following Intravenous Infusion of [14C]Bendamustine Hydrochloride in Patients With Relapsed or Refractory Malignancy (Hematologic or Nonhematologic) - Pharmacokinetics of bendamustine following infusion of 14C bendamustine
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •(a) The patient must have a histologically or cytologically confirmed, relapsed or
- •refractory malignancy (hematologic or nonhematologic) except for uveal melanoma,
- •sarcoma or primary brain tumors. Additionally, the malignancy must be considered
- •unresponsive or poorly responsive to accepted treatment modalities.
- •(b) The patient has a WHO performance status of 0-2.
- •(c) The patient has an estimated life expectancy of at least 3 months.
- •(d) Written informed consent is obtained.
- •(e) The patient is at least 18 years of age at the time of informed consent.
- •(f) NOTE: This inclusion criterion is no longer effective with the implementation of
- •amendment 3; it is replaced by inclusion criterion (k): The patient, if a woman, is
- •surgically sterile or 2 years postmenopausal.
- •(g) The patient, if a man, is surgically sterile, or, if capable of producing offspring, is
- •currently using an approved method of birth control and agrees to continued use of
- •this method for the duration of the study (and for 90 days after taking the last dose of
- •study medication due to possible effects on spermatogenesis). Acceptable methods
- •of contraception include abstinence, surgically sterile, female partner*s use of
- •steroidal contraceptive in conjunction with a barrier method, female partner*s use of
- •an intrauterine device (known to have a failure rate of less than 1% per year), or
- •female partner is surgically sterile for 2 years or more, or is 2 years postmenopausal.
- •In addition, men may not donate sperm for the duration of the study (and for 90 days
- •after taking the last dose of study medication).
- •(h) ANC >=1000 cells/mm3, platelet count >=100000 cells/mm3 and hemoglobin greater
- •than or equal to 9 g/dL.
- •(i) The patient has adequate hepatic function. For patients without liver metastases,
- •adequate hepatic function is defined as <=2.5 x upper limit of the normal range (ULN)
- •for aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline
- •phosphatase and <=1.5 x ULN for total bilirubin. For patients with liver metastases,
- •adequate hepatic function is defined as <=5xULN for AST and ALT, <=2.5xULN for
- •alkaline phosphatase, and <=1.5xULN for total bilirubin. Patients with nonclinically
- •significant elevations of bilirubin due to known or suspected Gilbert*s disease are
- •eligible; this must be documented on the medical history page of the CRF.
- •(j) The patient has a calculated creatinine clearance of >30 mL/minute as determined by
- •the Cockroft-Gault equation.
- •(k) The patient, if a woman, must be surgically sterile, 2 years postmenopausal, or, if of
- •child-bearing potential, using a medically accepted method of contraception, and
- •agree to continued use of this method for the duration of the study and for 90 days
- •after discontinuation of study drug. Acceptable methods of contraception include
- •abstinence or an intrauterine device (IUD) known to have a failure rate of less than
- •1% per year. NOTE: This inclusion criterion replaces inclusion criterion (f) and is
- •effective with the implementation of amendment 3.
排除标准
- •(a) The patient has had chemotherapy, radiotherapy, radioimmunotherapy, or immunotherapy within 28 days prior to the first dose of study drug or has not recovered from adverse events due to any agents administered previously. For patients who received therapy with mitomycin C, the interval is 42 days.
- •(b) The patient has known cerebral metastases.
- •(c) The patient is receiving treatment other than bendamustine for hematologic/nonhematologic malignancy.
- •(d) The patient has had any previous treatment with bendamustine.
- •(e) The patient has been treated with any hematopoietic growth factors within 14 days of study entry (patients on chronic erythropoiesis stimulating agents are allowed).
- •(f) The patient is pregnant or lactating.
- •(g) The patient has had a serious infection, medical condition, or psychiatric condition that, in the opinion of the investigator, should preclude the patient from participating in the study.
- •(h) The patient has a known positive test result for human immunodeficiency virus (HIV) or a history of HIV disease.
- •(i) The patient has presence of inflammatory bowel disease, occlusion of the gastrointestinal tract, significant constipation, or any condition resulting in clinically significant obstruction of the urinary tract.
- •(j) The patient requires treatment with cytochrome P450 1A2 (CYP1A2) inducers or inhibitors on days 1 through 8 of cycle 1, has used CYP1A2 inhibitors within 14 days before the 1st administration of study drug, or has used CYP1A2 inducers within 30 days before the 1st administration of study drug.
- •(k) NOTE: This exclusion criterion is no longer effective with the implementation of
- •amendment 3; it is replaced by inclusion criterion (m): The patient is a smoker or an ex-smoker who stopped smoking less than 12 months before the 1st dose of study drug or is using or has used topical or oral nicotine preparations for smoking cessation within the past 3 months before the 1st dose of study drug.
- •(l) The patient has known hypersensitivity to bendamustine or any if its components (ie, mannitol).
- •(m) The patient is a smoker or an ex-smoker who stopped smoking less than 3 months before the 1st dose of study drug or is using or has used topical or oral nicotine preparations for smoking cessation within the past 3 months before the 1st dose of study drug. NOTE: This exclusion criterion replaces inclusion criterion (k) and is effective with the implementation of amendment 3.
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