Health Condition 1: null- Chronic Myeloid Leukemia and or Gastrointestinal Stromal Tumor
Conditions
Interventions
Intervention1: Imatinib Mesylate Tablets 400 mg: Manufactured by: Natco Pharma Limited, India
Control Intervention1: Gleevec® (Imatinib Mesylate) Tablets 400 mg: Distributed by: Novartis Pharmaceutic
Sponsors
Natco Pharma 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. 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 SGOT and SGPT Serum Creatinine Absolute neutrophil count (ANC) >=1.5 x 109/L Platelets >= 100 x 109/L HbA1c 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.
Exclusion criteria
Exclusion criteria: 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 Investigatorâ??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 > 3. 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). 10. History of hematopoietic stem cell transplantation. 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 investigatorâ??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. 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. Any other condition or abnormal baseline findings that, in the investigatorâ??s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data ne
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the adverse events and to ensure the safety of the patients.Timepoint: 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. | — |
Countries
India
Contacts
Public ContactDr Ashoka Kumar Singh
Veeda Clinical Research Pvt. Ltd.
Outcome results
None listed