An open label, multicenter, balanced, randomized, two-treatment, two-period, two-sequence, two-way crossover, multiple-dose, steady state, comparative oral bioavailability study of Imatinib Mesylate Oral Solution 400mg/5ml of Shilpa Medicare Limited, India with Gleevec® (Imatinib mesylate) Tablets 400mg of Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936, in adult human patients with Chronic Myeloid Leukemia or Gastrointestinal Stromal Tumors under fed condition.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 6
- 主要终点
- To compare and evaluate the multiple dose oral bioavailability of Imatinib Mesylate Oral Solution 400mg/5ml of Shilpa Medicare Limited with Gleevec® (Imatinib mesylate) Tablets 400mg of Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936, in adult human patients with Chronic Myeloid Leukemia or Gastrointestinal Stromal Tumors under fed condition.
研究概览
简要总结
The Study is an open label, multicenter, balanced, randomized, two-treatment, two-period, two-sequence, two-way crossover, multiple-dose, steady state, comparative bioavailability study of Imatinib Mesylate Oral Solution 400mg/5ml of Shilpa Medicare Limited, India with Gleevec® (Imatinib mesylate) Tablets 400mg of Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936, in adult human patients with Chronic Myeloid Leukemia or Gastrointestinal Stromal Tumors under fed condition.
Primary Objective: To compare and evaluate multiple dose oral bioavailability of Imatinib Mesylate Oral Solution 400mg/5ml of Shilpa medicare Limited, India with Gleevec® (Imatinib mesylate) Tablets 400mg of Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936, in adult human patients with Chronic Myeloid Leukemia or Gastrointestinal Stromal Tumors under fed condition.
Secondary Objective: To monitor the adverse events and to ensure the safety of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Willing and able to provide voluntary informed consent and to follow the protocol requirements Male or Female aged 18 to 65 years both inclusive having body mass index BMI at least 17.00 calculated as weight in kg/height in m2 Patients with Philadelphia chromosome positive Chronic Myeloid Leukemia ph+ CML in their first three months of treatment in chronic phase and who are on a stable dose of 400mg of Imatinib and requiring a daily dose of Imatinib monotherapy OR Patients with Kit CD117 positive unresectable and/or metastatic malignant Gastrointestinal Stromal Tumor GIST who are on a stable dose of 400mg of Imatinib and requiring a daily dose of Imatinib monotherapy Eastern Cooperative Oncology Group ECOG performance status less or equal to 2 Acceptable hematology status Hemoglobin greater or equal to 9 g per dL Absolute neutrophil count ANC greater or equal to 1500 cells per mm3 Platelet count greater or equal to 100,000 cells per mm3 Acceptable liver function: Alanine aminotransferase less or equal to 2.5 X ULN Aspartate aminotransferase AST less or equal t 2.5 X ULN Bilirubin less or equal to 1.5 X ULN alkaline phosphatase less or equal to 2.5 X ULN Patients with creatinine clearance greater or equal to 60 mL per minute Patients with life expectancy of at least 3 months at the time of enrolment Female Patients with negative serum pregnancy test at Screening Women of child bearing potential, defined as women physiologically capable of becoming pregnant, unless they are using effective method of contraception during dosing of the investigational product practicing two acceptable methods of contraception Acceptable methods of contraception are Oral or parenteral injection, patch or implant hormonal contraception which has been used continuously for at least one month prior to the first dose of study medication Intrauterine device IUD or intrauterine system IUD per IUS Double barrier method of contraception Condom and occlusive cap or condom and spermicidal agent Male sterilization at least 6 months prior to the screening, should be the sole male partner for that Patient Female sterilization (surgical bilateral oophorectomy) or tubal ligation within at least 6 weeks prior to study participation Total abstinence, partial abstinence is not acceptable No history of addiction to any recreational drug or drug dependence or alcohol addiction.
排除标准
- •Known hypersensitivity or contraindication to Imatinib or to any of the components of investigational product
- •Patients with Ph+Chronic Myeloid Leukemia in accelerated phase or blastic phase
- •Patients with previous/current history of hematopoietic stem cell transplantation
- •Patients who have undergone Thyroidectomy
- •Patients on concomitant medication with drugs known to be inhibitors and/or inducers of CYP3A4 (Refer Appendix B)
- •Patients taking medications that irreversibly inhibit platelet function or anticoagulants
- •Patients with GI hemorrhage
- •Known CNS metastasis
- •Major surgical procedure (including periodontal) within 28 days of first dose of investigational product
- •Surgical or other non-healing wounds
- •Patients with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV)
- •Patients with positive urine screen for Drugs of Abuse
- •Patients with positive alcohol breath test
- •Has not recovered to Grade 0 or 1 toxicity from previous anticancer treatments or previous investigational agents.
- •Exceptions are alopecia (any grade is acceptable), Haemoglobin greater or equal to 9.0 g/dL, fatigue (Grade 2 is acceptable), and peripheral neuropathy (stable Grade 2 is acceptable) (Per National Cancer Institute [NCI]Common Terminology Criteria for Adverse Events [CTCAE], V5.0)
- •Participation in any clinical study within 90 days prior to receiving the first dose of Investigational Product
- •Loss of greater or equal to 350 ml of blood within 90 days prior to receiving the first dose of investigational product for the current study
- •Any other medical condition or uncontrolled systemic disease (e.g. cardiovascular disease, hypertension, diabetes mellitus etc.) that, in the opinion of the Investigator, may make it undesirable for the patient to participate in the study
- •Any other condition(s) which could significantly interfere with protocol compliance including, but not limited to, dementia, psychosis, cognitive impairment, altered mental status, or other major psychiatric disorder
- •Lactating women.
结局指标
主要结局
To compare and evaluate the multiple dose oral bioavailability of Imatinib Mesylate Oral Solution 400mg/5ml of Shilpa Medicare Limited with Gleevec® (Imatinib mesylate) Tablets 400mg of Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936, in adult human patients with Chronic Myeloid Leukemia or Gastrointestinal Stromal Tumors under fed condition.
时间窗: Day:1-Pre-dose blood sample within 1.00 hour prior to dosing, Day:6 and 14- Pre-dose blood sample (-48.0) and Day:7 and 15- Pre-dose blood sample (-24.0) within 1.00 hour prior to dosing, Day:8and16- Pre-dose blood sample (0.0) within 1 hour prior to dosing for 0.5 hours, 1.0 hrs., 1.5 hrs., 2.0 hrs., 2.5 hrs., 3.0 hrs., 3.5 hrs., 4.0 hrs., 5.0 hrs., 6.0 hrs., 8.0 hrs., 10.0 hrs., 12.0 hrs., 16.0 hrs. within ± 02 minutes, Day:09and17 – 24 hrs. within ± 02 minutes
次要结局
- To monitor the adverse events and to ensure the safety of patients.(Day:1-Pre-dose blood sample within 1.00 hour prior to dosing, Day:6 and 14- Pre-dose blood sample (-48.0) and Day:7 and 15- Pre-dose blood sample (-24.0) within 1.00 hour prior to dosing, Day:8and16- Pre-dose blood sample (0.0) within 1 hour prior to dosing for 0.5 hours, 1.0 hrs., 1.5 hrs., 2.0 hrs., 2.5 hrs., 3.0 hrs., 3.5 hrs., 4.0 hrs., 5.0 hrs., 6.0 hrs., 8.0 hrs., 10.0 hrs., 12.0 hrs., 16.0 hrs. within ± 02 minutes, Day:09and17 – 24 hrs. within ± 02 minutes)