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临床试验/CTRI/2017/08/009356
CTRI/2017/08/009356进行中（未招募）不适用

A multicenter, open label, randomized, balanced, steady state, two treatment, two period, two sequence, two-way crossover, multiple dose, bioequivalence study of Imatinib Mesylate Tablet 400 mg of Natco Pharma Limited, India with Gleevec® (Imatinib Mesylate) Tablet 400 mg of Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936 in adult human patients with Chronic Myeloid Leukemia and/or Gastrointestinal Stromal Tumor stabilized on Imatinib Mesylate 400 mg under fed condition.

Natco Pharma Limited7 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年8月21日最近更新:
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试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
40
试验地点
7
主要终点
To assess the bioequivalence of Imatinib Mesylate Tablet 400 mg of Natco Pharma Limited, India with Gleevec® (Imatinib Mesylate) Tab 400 mg of Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936 in adult human patients with Chronic Myeloid Leukemia and/or Gastrointestinal Stromal Tumor stabilized on Imatinib Mesylate 400 mg under fed condition.
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Imatinib mesylate is a protein-tyrosine kinase inhibitor that inhibits the BCR-ABL tyrosine kinase, the constitutive abnormal tyrosine kinase created by the Philadelphia chromosome abnormality in CML. Imatinib inhibits proliferation and induces apoptosis in BCR-ABL positive cell lines as well as fresh leukemic cells from Philadelphia chromosome positive chronic myeloid leukemia. Imatinib inhibits colony formation in assays using ex vivo peripheral blood and bone marrow samples from CML patients. 

In vivo, Imatinib inhibits tumor growth of BCR-ABL transfected murine myeloid cells as well as BCR-ABL positive leukemia lines derived from CML patients in blast crisis.

Imatinib is also an inhibitor of the receptor tyrosine kinases for platelet-derived growth factor (PDGF) and stem cell factor (SCF), c-kit, and inhibits PDGF- and SCF-mediated cellular events. In vitro, Imatinib inhibits proliferation and induces apoptosis in GIST cells, which express an activating c-kit mutation

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
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

  • •1.Men and women, of age in between 18 years to 65 years (both inclusive).
  • •2.Ability to provide written informed consent prior to participation in the study.
  • •3.Chronic phase Chronic Myeloid Leukemia (CML) patients with documented evidence of Philadelphia positive chromosome who are on stable dose regimen of 400 mg once daily dose of Imatinib.
  • •And/Or Kit (CD 117) positive Gastrointestinal Stromal Tumor (GIST) (with documented evidence), who are on a stable dose regimen of 400 mg once daily dose of Imatinib.
  • •4.Adequate organ function, defined as the following: Hemoglobin > 9 mg/dL Total bilirubin < 1.5 x upper limit of normal (ULN) SGOT and SGPT < 2.5 x ULN Serum Creatinine < 1.5 x ULN Absolute neutrophil count (ANC) ≥1.5 x 109/L Platelets ≥ 100 x 109/L HbA1c < 9 % 5.Females of child-bearing potential (FOCP) must have negative pregnancy test at screening and must agree to use an acceptable method of birth control such as sexual abstinence or at least 2 reliable modes of contraception, one of which must be a double-barrier method (e.g., condom with spermicidal gel or diaphragm with spermicidal gel) or IUD or vaginal spermicidal suppository from screening until 14 days after last dose of study drug.
  • •[Note: Use of hormonal contraception (pills/hormonal intrauterine device etc,) is not allowed.] Patient agrees to accept the risk that pregnancy could still result despite using birth control devices.
  • •OR Post-menopausal females defined as 12 consecutive months of amenorrhea.
  • •OR Surgically sterilized females with documented evidence of hysterectomy / bilateral salpingectomy / bilateral oophorectomy.
  • •Females without documented evidence of surgery and those who has undergone tubal ligation will be considered of child bearing potential.
  • •6.Male patient must agree to use an acceptable method of birth control such as sexual abstinence or barrier method of contraception (i.e. condom) from screening until 14 days after last dose of study drug.
  • •Patient agrees to accept the risk that pregnancy in female partner could still result despite using birth control devices.
  • •7.No history of participation in any clinical study within the past 90 days.

排除标准

  • •1.Patients in accelerated phase or blast crisis phase.
  • •2.Patients for whom a titration away from 400 mg dose is likely during the entire study period as per Investigator’s judgement.
  • •3.Patient received any treatment for CML prior to study entry for longer than 2 weeks with the exception of hydroxyurea and/or anagrelide and/or imatinib.
  • •4.History of patient with another primary malignancy except if the other primary malignancy is neither currently clinically significant or requiring active intervention.
  • •5.Patient having history of major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery.
  • •6.Patients with an ECOG (Eastern Cooperative Oncology group) Performance Status Score >
  • •7.Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent.
  • •8.Patients with identified sibling donors where allogeneic bone marrow transplant is elected as first line treatment.
  • •9.Patients who are on or may require concomitant medications which are known to be inhibitors and/or inducers of CYP3A4 family (Annexure IV).
  • •11.History of hypersensitivity to Imatinib or any of its excipients or related group of drugs.
  • •12.Patients who are eligible and willing to undergo transplantation during the entire study period.
  • •13.History of patients taking certain medications that are accepted to have a risk of causing Torsades de Pointes.
  • •14.History of patients taking medications that irreversibly inhibit platelet function or anticoagulants.
  • •15.History of uncontrolled diseases, such as thyroidal dysfunction, diabetes mellitus, angina pectoris, heart failure, neuropsychiatric disorders.
  • •16.Patients who are at clinically high risk of developing Tumor Lysis Syndrome as per the investigator’s evaluation.
  • •17.Patients who have undergone thyroidectomy or patients receiving levothyroxine.
  • •18.Patients with history of bullous dermatologic reactions, including erythema multiforme and Stevens-Johnson syndrome during the prior therapy with imatinib or any other drug.
  • •19.Recent history (within 6 months) of alcohol and/or drug addiction.
  • •20.Patients who are human immunodeficiency virus (HIV) and HbsAg positive.
  • •21.History of ascites and rapid weight gain with or without superficial edema.
  • •22.History of prior radiotherapy to bone marrow.
  • •23.Use of other concurrent anticancer agents other than Imatinib, including chemotherapy or biologic agents.
  • •24.Positive results for drugs of abuse (benzodiazepines, opioids, amphetamines, cannabinoids cocaine and barbiturates) in urine.
  • •25.Positive results for alcohol as detected by Alcohol Breath Analyzer.
  • •26.History of difficulty with donating blood or difficulty in accessibility of veins.
  • •29.History of patient for whom oral administration of drug is not possible.
  • •30.Any other condition or abnormal baseline findings that, in the investigator’s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.

结局指标

主要结局

To assess the bioequivalence of Imatinib Mesylate Tablet 400 mg of Natco Pharma Limited, India with Gleevec® (Imatinib Mesylate) Tab 400 mg of Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936 in adult human patients with Chronic Myeloid Leukemia and/or Gastrointestinal Stromal Tumor stabilized on Imatinib Mesylate 400 mg under fed condition.

时间窗: A total of thirty-eight (38) blood samples will be collected during study. The pre-dose blood sample | on Day 5 to day 7 and Day 12 to 14 will be collected within 5 minutes before dosing time. On Day 7 | and 14, the post-dose blood samples of 3.0 mL each will be drawn at 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, | 3.50, 4.00, 4.50, 5.00, 6.00, 8.00, 10.00, 12.00, 18.00 and 24.00 hrs following drug administration in each period for each subject.

次要结局

  • To monitor the adverse events and to ensure the safety of the patients.(Physical examination on screening, prior to check-in in each period on day 0, day 4, day 11 and during post study safety assessment after last PK sample in Period II. Oral body temperature, blood pressure, pulse rate at Screening, Day 0, Day 1, Day 5, Day 6 in Period I and on Day 8, Day 12, Day 13 in Period II, On Day 7 & Day 14 at predose & 1 hr, 3 hr, 6 hr, 13 hr post dose and during post study safety assessment after last PK sample in Period II.)

研究者

申办方类型
Pharmaceutical industry-Indian

研究点 (7)

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