CTRI/2013/02/003435已完成未知
A multicenter, open label, randomized, balanced, two treatment,two period, two sequence, two way crossover, multiple dose,comparative oral bioavailability study of Imatinib mesylate tablets400mg of Onco Therapies Limited (a subsidiary of Strides ArcolabLtd.), India with Gleevec® (Imatinib Mesylate) Tablets 400mg ofNovartis Pharmaceuticals Corporation, East Hanover, New Jerseyin adult human patients with Chronic Myeloid Leukemia and/orGastrointestinal Stromal Tumor under fed steady-state condition
Onco Therapies Limited A subsidiary of Strides Arcolab Ltd0 个研究点目标入组 32 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •Men and women 18 years of age or older.
- •2. Ability to provide written informed consent prior to
- •participation in the study
- •3. Women of childbearing potential must have a
- •negative serum or urine pregnancy test must be
- •using an adequate method of contraception.
- •4. Patients with
- •Chronic Phase Philadelphia positive CML who are on stable dose
- •regimen of 400mg daily dose
- •Gastrointestinal Stromal Tumor (GIST) who are on
- •a stable dose regimen of 400 mg daily dose
- •5. Documented chronic phase CML as defined by
- •< 15 % blasts in peripheral blood and bone marrow
- •< 30% blasts plus promyelocytes in peripheral bloodand bone marrow
- •< 20% basophils in the peripheral blood
- •>= 100 x 109/L (>= 100,000 /mm3) platelets
- •No evidence of extramedullary leukemic
- •involvement with the exception of
- •hepatosplenomegaly
- •6. Adequate organ function, defined as the following:
- •total bilirubin < 1.5 x upper limit of normal (ULN)
- •SGOT and SGPT < 2.5 x ULN
- •Creatinine < 1.5 x ULN
- •Absolute neutrophil count (ANC) > 1.5 x 109/L
- •Platelets > 100 x 109/L
- •7. Patients for whom a titration away from 400 mg
- •dose is unlikely, such as patients with
- •gastrointestinal stromal tumors and patients in their
- •first three months of treatment for chronic
- •myeloid leukemia (CML).
排除标准
- •Patients in accelerated phase or blastic phase are
- •2. Patients who require 400mg daily dose of Imatinib
- •3. Patient received any treatment for CML prior to
- •study entry for longer than 2 weeks with the
- •exception of hydroxyurea and/or anagrelide
- •4. Patients with another primary malignancy except if
- •the other primary malignancy is neither currently
- •clinically significant or requiring active intervention
- •5. Patients who are:
- •Breast feedingOf childbearing potential without a negative
- •pregnancy test prior to baseline
- •Male or female of childbearing potential unwilling
- •to use barrier contraceptive precautions throughout
- •Patient had major surgery within 4 weeks prior to
- •study entry, or who have not recovered from prior
- •major surgery
- •Patients with an ECOG Performance Status Score >=
- •Patients with International normalized ratio (INR) or
- •partial thromboplastin time (PTT) 1.5 x IULN,
- •with the exception of patients on treatment with oral
- •anticoagulant
- •Patients with known positivity for human
- •immunodeficiency virus (HIV)
- •Patients with any significant history of noncompliance
- •to medical regimens or with inability to
- •grant a reliable informed consent
研究者
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