Health Condition 1: null- Chronic Myeloid Leukemia
Conditions
Interventions
Intervention1: GLIVEC® (Imatinib Mesylate) tablets 400 mg tablet: 400 mg of Onco Therapies Limited
Intervention2: Imatinib mesylate tablets 400mg tablet once daily: Onco Therapies Limited (a subsidia
Sponsors
Onco Therapies Limited which is a subsidiary of Strides Arcolab Ltd
Veeda clinical research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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 And/Or Gastrointestinal Stromal Tumor (GIST) who are on a stable dose regimen of 400 mg daily dose 5. Documented chronic phase CML as defined by: blood and bone marrow >= 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 (ULN) SGOT and SGPT Creatinine 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
Exclusion criteria
Exclusion criteria: 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: Pregnant 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare and evaluate the multiple-dose oral bioavailability 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 of Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom in adult human patients with Chronic Myeloid Leukemia and/or Gastrointestinal StromalTumor under fed steady-state conditionTimepoint: The pre-dose blood sample of 3.0mL (00.00) will be collected within one hour prior to the dosing time on day 1. The pre-dose blood sample on Day 6 to day 8 and on Day 9, Day 14 to 16 will be collected within 5 minutes before dosing time. On day 8 and 16, the post-dose blood samples of 3.0mL each will be drawn at 0.5, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 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 PatientTimepoint: N/A | — |
Countries
India
Contacts
Public ContactDr Brijesh Wadekar
Veeda Clinical Research Pvt. Ltd.
Outcome results
None listed