This is comparative study for the Imatinib Mesylate 400mg tablets with Imatinib Mesylate 400mg tablets of ( Gleevec)Novartis Pharmaceuticals Corporation, East Hanover, New Jersey in patients with Chronic Myeloid Leukemia and/or Gastrointestinal Stromal Tumor under fed steady-state condition.

Not Applicable

Completed

• Conditions: Health Condition 1: null- Cancer Patients

• Registration Number: CTRI/2013/02/003435
• Lead Sponsor: Onco Therapies Limited A subsidiary of Strides Arcolab Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 32

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

< 15 % blasts in peripheral blood and bone marrow

< 30% blasts plus promyelocytes in peripheral bloodand bone marrow

< 20% basophils in the peripheral blood

>= 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 < 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 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

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

Study & Design

• Study Type: BA/BE
• Study Design: Not specified