NL-OMON40403已完成不适用
An Open Label Study to Investigate the Pharmacokinetics (Absorption, Distribution, Metabolism, and Excretion) of Omacetaxine Mepesuccinate Following Subcutaneous Administration of [14C]c in Patients with Relapsed and/or Refractory Hematologic Malignancies or Advanced Solid Tumors. - TEVA C41443/1103
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- TEVA Pharma
- 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) Written informed consent is obtained.
- •(b) The patient is at least 18 years of age at the time of informed consent.
- •(c) The patient has a histologically or cytologically confirmed diagnosis of:
- •- Relapsed or refractory leukemia, including Philedelphia chromosome-positive (Ph+), chronic myelogenous leukemia (CML), acute promyelocytic leukemia (APL), acute myelogenous leukemia (AML), or myelodysplastic syndrome (MDS).
- •- Advanced solid tumors (ie, breast, lung, head/neck, colorectal, melanoma, and sarcoma). The malignancy must be considered unresponsive to accepted available therapies.
- •(d) The patient has an estimated life expectancy of at least 3 months.
- •(e) The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of <=2.
- •(f) The patient, if a man, is surgically sterile, or, if capable of producing offspring, is currently using a medically acceptable method of birth control and agrees to continued use of this method for the duration of the study (and for 90 days after the last dose of study medication). Acceptable methods of contraception include abstinence, surgical sterility, 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).
- •(g) The patient, if a woman, must be surgically sterile or 2 years postmenopausal.
- •(h) The patient has QTc <450 msec (using Bazett*s and Fridericia*s correction).
- •(i) The patient has adequate hepatic function (normal to mild dysfunction). Normal hepatic function, is defined as *upper limit of the normal range (ULN) for aspartate aminotransferase (AST) and total bilirubin. Mild hepatic dysfunction is defined as follows: (a) >ULN for AST and <=1.5x ULN for total bilirubin or (b) any for AST and >1.0-1.5xULN for total bilirubin. Patients with nonclinically significant elevations of bilirubin up to 5.0 g/dL (85500 µmol/L) 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 adequate renal function (normal to mild dysfunction), with a calculated creatinine clearance (CLCR) of >=60 mL/minute (>=1.0 mL/s), as determined by the Cockroft-Gault equation.
- •(k) The patient must be willing and able to comply with study restrictions and to remain at the study center for the required duration during assessment period A.;Patients with non-hematologic malignancies
- •(l) The patient has an absolute neutrophil count (ANC) of >=1000 cells/mm3, a platelet count >=100000 cells/mm3, and a hemoglobin value >=8 g/dL.;Patients with hematologic malignancies
- •(m) The patient has a hemoglobin value which is, in the opinion of the investigator, adequate given the blood draw requirements of the study.
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 is receiving any other treatment for hematologic/nonhematologic malignancy.
- •(c) The patient has had previous treatment with omacetaxine mepesuccinate.
- •(d) The patient has been treated with any hematopoietic growth factors within 14 days of study entry (patients on chronic erythropoiesis stimulating agents are allowed).
- •(e) The patient has New York Heart Association (NYHA) Class 3 or 4 heart disease, active ischemia, or any uncontrolled, unstable cardiac condition for which treatment for the condition is indicated but is not controlled despite adequate therapy, including angina pectoris, cardiac arrhythmia, hypertension, or congestive heart failure.
- •(f) The patient has experienced a myocardial infarction within the previous 12 weeks.
- •(g) The patient has a solid tumor with symptomatic central nervous system (CNS) metastases.
- •(h) The patient has an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment.
- •(i) The patient is pregnant or lactating.
- •(j) The patient has had a serious medical or psychiatric condition that, in the opinion of the investigator, should preclude the patient from participating in the study.
- •(k)The patient has
- •* a positive test result for hepatitis B surface antigen (HBsAg) or
- •antibodies to hepatitis C (serology tests for HBsAg and hepatitis C
- •antibodies must be negative), and/or
- •* a known positive test result for human
- •immunodeficiency virus (HIV) or a history of
- •HIV disease (if HIV status is unknown it is assumed
- •that it is negative).
- •(l) 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 gastrointestinal tract.
- •(m) The patient has any condition resulting in a clinically significant obstruction of the urinary tract.
- •(n) The patient has known hypersensitivity to omacetaxine mepesuccinate, mannitol, or any other components of the study drug.
- •(o) The patient is considered unsuitable for any other reason, as judged by the investigator.
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