Health Condition 1: C921- Chronic myeloid leukemia, BCR/ABL-positive Health Condition 2: C269- Malignant neoplasm of ill-definedsites within the digestive system
Conditions
Interventions
Intervention1: Imatinib Mesylate 400mg
Manufactured by Eugia Pharma Specialities Limited, India: This study will consists of two periods and is multiple dose study. Eligible patients will be administ
)for 7
consecutive days in each period crossed over without washout.
Control Intervention1: Gleevec(R) -Imatinib Mesylate 400mg
Distributed by Novartis Pharmaceuticals Corporation, USA.: This study w
)for 7 consecutive days in each period crossed over without washout.
Sponsors
Eugia Pharma Specialities Limited A JV of Aurobindo Pharma Limited and Celon Laboratories Limited
AXIS Clinicals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female subject aged between 18 and 65 years of age (both inclusive) at the time of informed consent and should have BMI >= 18.5 to 2.Subject with chronic phase Ph+ CML (Philadelphia chromosome positive Chronic Myeloid Leukemia) in their first three months of treatment and /or Gastro Intestinal Stromal Tumors (GIST) who are on stable dose regimen of Imatinib Mesylate 400 mg daily dose 3.Subject with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase OR Subject with GIST diagnosed histologically with expressing CD117+ or with documented mutation of the KIT or PDGFRA gene 4.Female subject of childbearing potential should be willing to use a reliable method of birth control 5.Female subject must have a negative pregnancy test at Screening. 6.Subject should be otherwise healthy as determined by general and systemic examination, medical history and have no significant abnormality in any of the laboratory parameters including ECG and Chest X-ray. 7.Subject with ECOG (Eastern Cooperative Oncology Group) performance status 0-2 8.Subject with no history of addiction to any recreational drug or drug dependence 9.Subject must be able to adhere to the study visit schedule and other protocol requirements and must have given informed consent prior to any screening procedures.
Exclusion criteria
Exclusion criteria: 1.Subject with history of accelerated or blast phase CML 2.Subject with history of ascites and rapid weight gain with or without superficial edema 3.Subject had uncontrolled diabetes mellitus at the discretion of Principal Investigator 4.Subject with history of hematopoietic stem cell transplantation. 5.Subject had prior radiotherapy to bone marrow 6.Subject undergone major surgery within 4 weeks of enrolment. 7.Subject use of other concurrent anticancer agents, including chemotherapy or biologic agents. 8.Subject had history of hypersensitivity or idiosyncratic reactions to any drug product or its excipients etc 9.History of difficulty with donating blood or difficulty in swallowing the drug or difficulty in accessibility of veins. 10.High caffeine (more than 5 cups of coffee or tea/day) or tobacco (more than 9 cigarettes/ beedies/ cigars per day) consumption. 11.Subject diagnosed to be HIV 1 and 2 or Hepatitis B (HBs Ag) or Hepatitis C (HCV) virus reactive/positive. 12.Female subject who is pregnant or currently breast-feeding. 13.Subject donated blood >= 350 mL within 90 days of screening. 14.Subject participation in another clinical trial within the preceding 90 days of study starts. 15.Use of concomitant medication with drugs known to be inhibitors and/or inducers of CYP3A4 family and acetaminophen (paracetamol) 16.Subject with history of arterial thrombosis or deep vein thrombosis within the past year 17.Subject had significant pre-existing co-morbidities a. Cardiovascular • Congestive heart failure • Uncontrolled hypertension b. Pulmonary • pleural effusion, pulmonary edema c. Neurologic and psychiatric • History of significant neurologic or psychiatric disorder that would preclude study compliance or ability to give informed consent d. Gastrointestinal • Severe Diarrhea and Vomiting • Inflammatory bowel diseases Liver or Kidney disease
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Css-avg: Average concentration over the steady state dosing interval.Timepoint: Day 1, 5, 6, 8, 12 and 13: Venous blood samples will be withdrawn 5 minutes prior to morning dosing to confirm steady state condition. ( 3 days/ 12 mL/ period) Day 7 and 14: Venous blood samples will be withdrawn at 0.00 (pre-dose) and 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 18.00 and 24.00 hours of post dose in each period. | — |
Primary
| Measure | Time frame |
|---|---|
| AUC0-ï?´ -: Area under the plasma concentration â?? time curve over the steady state dosing interval. Cmax-ss: Maximum concentration over the steady state dosing interval. Timepoint: Day 1, 5, 6, 8, 12 and 13: Venous blood samples will be withdrawn 5 minutes prior to morning dosing to confirm steady state condition. ( 3 days/ 12 mL/ period) Day 7 and 14: Venous blood samples will be withdrawn at 0.00 (pre-dose) and 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 18.00 and 24.00 hours of post dose in each period. | — |
Countries
India
Contacts
Public ContactDr Subhra Lahiri
AXIS Clinicals Limited
Outcome results
None listed