Health Condition 1: null- Adult human patients with Chronic Myeloid Leukemia and/or Gastrointestinal Stromal Tumor
Conditions
Interventions
Intervention1: Imatinib Mesylate Tablets 400mg once daily for 7
days.Overall treatment period in the study is of 14
days i.e. 7 days of period I and 7 days of period II.
Patient will be administered I
Sponsors
Dr Reddys Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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. 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 chromosome positive Chronic Myeloid Leukemia who are on stable dose regimen of 400mg daily dose of Imatinib And/Or Gastrointestinal Stromal Tumor (GIST) who are on a stable dose regimen of 400 mg daily dose of Imatinib 5. Documented evidence of chronic phase CML & positive for Philadelphia chromosome 6. Adequate organ function, defined as the following: ï?? Total bilirubin ï?? SGOT and SGPT ï?? Serum Creatinine ï?? Absolute neutrophil count (ANC) >= 1.5 x 109/L ï?? Platelets >= 100 x 109/L 7. Patients for whom a titration away from 400 mg dose is unlikely. 8. No history of addiction to any recreational drug or drug dependence 9. No history of participation in any clinical study within the past 90 days
Exclusion criteria
Exclusion criteria: 1. Patients in accelerated phase or blastic phase are excluded 2. History of 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. History of patients with another primary malignancy except if the other primary malignancy is neither currently clinically significant or requiring active intervention 5. Patients who are: ï?? Pregnant ï?? Breast feeding ï?? Of childbearing potential without a negative pregnancy test prior to baseline ï?? Male or female of childbearing potential unwilling to use barrier contraceptive precautions throughout the trial 6. Patient having history of major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery 7. Patients with an ECOG (Eastern Cooperative Oncology group) Performance Status Score >= 3 8. Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent 9. Patients with identified sibling donors where allogeneic bone marrow transplant is elected as first line treatment 10. Taking CYP3A4 inhibitors and/or inducers which is as per the detailed drug list in Annexure IV. 11. Having History of Hematopoietic stem cell transplantation. 12. History of hypersensitivity to Imatinib or any of its excipients or related group of drugs. 13. Patients who are eligible and willing to undergo transplantation during the screening period. 14. History of patients taking certain medications that are accepted to have a risk of causing Torsades de Pointes. 15. History of patients taking medications that irreversibly inhibit platelet function or anticoagulants. 16. History of Uncontrolled diseases, such as thyroidal dysfunction, diabetes mellitus, angina pectoralis, serious heart failure, neuropsychiatric infection or disease. 17. History of alcohol and/or drug addiction. 18. Patients with known positivity for human immunodeficiency virus (HIV), HBsAg and HCV 19. History of ascites and rapid weight gain with or without superficial edema 20. Grade 3 or 4 neutropenia and thrombocytopenia as per the screening laboratory reports. 21. History of hematopoietic stem cell transplantation. 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. 27. An unusual or abnormal diet, for whatever reason e.g. religious fasting. 28. High caffeine (more than 5 cups of coffee or tea/day) or tobacco (more than 9 cigarettes/ beedies/ cigars per day) consumption. 29. History of patient for whom oral administration of drug is not possible. 30. History of donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product in the study. 31. Any other condition or abnormal baseline findings that, in the investigatorâ??s judgment, migh
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ To assess the bioequivalence of Imatinib Mesylate Tablets 400mg of Dr. Reddyâ??s Laboratories Limited, India with Gleevec® (Imatinib Mesylate) Tablets 400mg of Novartis Pharmaceuticals Corporation, East Hanover, New Jersey in adult human patients with Chronic Myeloid Leukemia and/or Gastrointestinal Stromal Tumor stabilized on Imatinib Mesylate 400 mg under fed condition.Timepoint: The pre-dose blood sample of 3.0mL (0.00) will be collected within one hour prior to the dosing time on Day 1.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 3.0mL 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the adverse events and to ensure the safety of the patientsTimepoint: Adverse events/ Serious Adverse Events will be recorded from the time of first administration of the IMP until 30 days after the last dose of study drug administration. | — |
Countries
India
Contacts
Public ContactDr Brijesh Wadekar
Veeda Clinical Research Pvt. Ltd.
Outcome results
None listed