CTRI/2013/04/003546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 tablets 400mg of Onco Therapies Limited (a subsidiary of Strides Arcolab Ltd.), India with GLIVEC® (Imatinib Mesylate) tablets 400 mg film coated tablets marketed by Novartis Europharm LimitedWimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom in adult human patients with Chronic Myeloid Leukemia and/or Gastrointestinal Stromal Tumor under fed steady-state condition.
Onco Therapies Limited which is 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
- •1. 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 Ph+ 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 bonemarrow
- •< 30% blasts plus promyelocytes in peripheral
- •blood and bone marrow
- •< 20% basophils in the peripheral blood
- •>= 100 x 10 to the power of 9/L (>= 100,000 /mm cube) 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
- •SGOT and SGPT < 2.5 x ULN
- •Creatinine < 1.5 x ULN
- •Absolute neutrophil count (ANC) > 1.5 x 10 to the power of 9/L
- •Platelets > 100 x 10 to the power of 9/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).
- •8. No history of addiction to any recreational drug or drug dependence
- •9. No participation in any clinical study within the past 90 days
排除标准
- •1. Patients in accelerated phase or blastic phase are excluded
- •2. Patients who require greater than 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 feeding
- •Of childbearing potential without a negative
- •pregnancy test prior to baseline
- •Male or female of childbearing potential
- •unwilling to use barrier contraceptive
- •precautions throughout the trial
- •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 greater than equal to 3
- •Patients with International normalized ratio
- •(INR) or partial thromboplastin time (PTT) greater than 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
- •Patients with identified sibling donors where
- •allogeneic bone marrow transplant is elected
- •as first line treatment
- •Taking CYP3A4 inhibitors and/or inducers
- •Having History of Hematopoietic stem cell
- •transplantation.
- •6.Intolerance to Imatinib at any dose.
- •7.Subjects who are eligible and willing to undergo transplantation during the screening period.
- •8.Subjects taking certain medications that are accepted to have a risk of causing Torsades de Pointes.
- •9.Subjects taking medications that irreversibly inhibit platelet function or anticoagulants.
- •10.Uncontrolled diseases, such as thyroidal dysfunction, diabetes mellitus, angina pectoralis, serious heart failure, neuropsychiatric infection or disease.
- •11.History of Alcohol and/or drug addiction.
- •12.History of accelerated or blast phase CML
- •13.With history of ascites and rapid weight gain with or without superficial edema
- •14.Grade 3 or 4 neutropenia and thrombocytopenia
- •15.Uncontrolled diabetes mellitus
- •16.History of hematopoietic stem cell transplantation.
- •17.Prior radiotherapy to bone marrow
- •18.Major surgery within 4 weeks of enrolment..
- •19.Use of other concurrent anticancer agents, including chemotherapy or biologic agents.
- •20.Positive results for drugs of abuse (benzodiazepines, opioids, amphetamines, cannabinoids cocaine and barbiturates) in urine
- •21.Positive results for alcohol as detected by Alcohol Breath Analyzer.
- •22.History of difficulty with donating blood or difficulty in accessibility of veins.
- •23.An unusual or abnormal diet, for whatever reason e.g. religious fasting.
- •24.High caffeine (more than 5 cups of coffee or tea/day) or tobacco (more than 9 cigarettes/ beedies/ cigars per day) consumption.
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