Health Condition 1: null- Cancer Patients
Conditions
Interventions
Intervention1: Imatinib mesylate 400 mg tablet once daily for 8 days (Period I or Period II)during the study.: Onco Therapies Limited a subsidiary of Strides Arcolab Ltd
Control Intervention1: Imatini
Sponsors
Onco Therapies Limited A subsidiary of Strides Arcolab Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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 Philadelphia positive 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 >= 100 x 109/L (>= 100,000 /mm3) platelets No evidence of extramedullary leukemic involvement with the exception of hepatosplenomegaly 6. Adequate organ function, defined as the following: total bilirubin SGOT and SGPT Creatinine Absolute neutrophil count (ANC) > 1.5 x 109/L Platelets > 100 x 109/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).
Exclusion criteria
Exclusion criteria: Patients in accelerated phase or blastic phase are excluded 2. 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. 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 feedingOf 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 >= 3 Patients with International normalized ratio (INR) or partial thromboplastin time (PTT) 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
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 and Gleevec®(imatinib mesylate)Tablets 400mg of Novartis Pharmaceuticals Corporation,East Hanover, New Jersey in CML and/or Gastrointestinal Stromal Tumor patients under fed steady-state conditions as well as to monitor the safety of Patients. Timepoint: The pre-dose blood sample of 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 samples of will be drawn at 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the adverse events and to ensure the safety of PatientTimepoint: NA | — |
Countries
India
Contacts
Public ContactDr Brijesh Wadekar
Veeda Clinical Research Pvt. Ltd.
Outcome results
None listed