This is comparative study for the Imatinib Mesylate 400mg tablets with Imatinib Mesylate 400mg tablets of (GLIVEC®)Novartis Europharm Limited, United Kingdom in patients with Chronic Myeloid Leukemia and/or Gastrointestinal Stromal Tumor under fed steady-state condition.
- Conditions
- Health Condition 1: null- Chronic Myeloid Leukemia
- Registration Number
- CTRI/2013/04/003546
- Lead Sponsor
- Onco Therapies Limited which is a subsidiary of Strides Arcolab Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 32
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:
< 15% blasts in peripheral blood and bonemarrow
< 30% blasts plus promyelocytes in peripheral
blood and bone marrow
< 20% basophils in the peripheral blood
>= 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 < 1.5 x upper limit of normal
(ULN)
SGOT and SGPT < 2.5 x ULN
Creatinine < 1.5 x ULN
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
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.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method