Health Condition 1: C921- Chronic myeloid leukemia, BCR/ABL-positive
Conditions
Interventions
Intervention1: Imatinib Mesylate 400 mg: Natco Pharma Limited India
Natco House
Road No2 Banjara Hills
Hyderabad 500 034 India
Intervention2: Imatinib Mesylate
400 mg: Natco Pharma Limited India
Co
Sponsors
Natco Pharma Limited
CliNovi Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Men and women of age in between 18 years to 65 years both inclusive Ability to provide written informed consent prior to participation in the study 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 mesylate And Or Kit CD117 positive Gastrointestinal Stromal Tumor GIST with documented evidence who are on a stable dose regimen of 400 mg once daily dose of Imatinib mesylate Adequate organ function defined as the following Hemoglobin 9 mg dL Total bilirubin 1.5 upper limit of normal ULN SGOT and SGPT 2.5 ULN Serum Creatinine 1.5 ULN Absolute neutrophil count ANC 1.5 109 L Platelets 100 109 L HbA1c 9 percent 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 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 Patients agree 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 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 childbearing potential Male patient must agree to use an acceptable method of birth control such as sexual abstinence or barrier method of contraception condom from screening until 14 days after last dose of study drug Patients agree to accept the risk that pregnancy in female partner could still result despite using birth control devices No history of participation in any clinical study within the past 90 days Patients should be screened for hepatotoxicity prior to enrollment and the protocol should include procedures to monitor hepatotoxicity during the course of the study
Exclusion criteria
Exclusion criteria: The patient will be excluded based on the following criteria Patients in accelerated phase or blast crisis phase Patients for whom a titration away from 400 mg dose is likely during the entire study period as per Investigators judgement 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 mesylate History of patient with another primary malignancy except if the primary malignancy is neither currently clinically significant or requiring active intervention Patients having history of major surgery within 4 weeks prior to study entry or who have not recovered from prior major surgery Patients with an ECOG Eastern Cooperative Oncology group Performance Status Score 3 Patients with any significant history of non-compliance 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 Patients who are on or may require concomitant medications which are known to be inhibitors and or inducers of CYP3A4 family History of hematopoietic stem cell transplantation History of Hypersensitivity to imatinib mesylate or any of its excipient or related group of drugs Patients who are eligible and willing to undergo transplantation during the entire study period History of patients taking certain medications that are accepted to have a risk of causing Torsades de Pointes History of patients taking medications that irreversibly inhibit platelet function or anticoagulants History of uncontrolled diseases such as thyroidal dysfunction diabetes mellitus angina pectoris heart failure neuropsychiatric disorders Patients who are at clinically high risk of developing Tumor Lysis Syndrome as per the investigator evaluation Patients who have undergone thyroidectomy or patients receiving levothyroxine Patients with history of bullous dermatologic reaction including erythema multiforme and Stevens Johnson syndrome during the prior therapy with imatinib mesylate or any other drug Recent history within 6 months of alcohol and/or drug addiction Patients who are human immunodeficiency virus and HCV Antibody positive History of ascites and rapid weight gain with or without superficial edema History of prior radiotherapy to bone marrow Use of other concurrent anticancer agents other than Imatinib mesylate including chemotherapy or biological agent Positive results for drugs of abuse benzodiazepines opioids amphetamines cannabinoids cocaine and barbiturates in urine Positive results for alcohol in urine History of difficulty with donating blood or difficulty in accessibility of veins An unusual or abnormal diet for whatever reason religious fasting High caffeinemore than 5 cups of coffee or tea day or tobacco more than cigarettes beedis cigars per day consumption History of patient for whom oral administration of drug is not possible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the rate and extent of absorption of Test Product Imatinib Mesylate 400 mg Tablets of Natco Pharma Limited India with Reference Product Gleevec Imatinib Mesylate Tablet 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 conditionsTimepoint: 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of Imatinib Mesylate 400 mg tabletsTimepoint: 6 Months safety | — |
Countries
India
Contacts
Public ContactRadhika Inapakolla
CliNovi Research Pvt. Ltd.
Outcome results
None listed