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Gleevec (Imatinib Mesylate) - Summary

 
 



GLEEVEC SUMMARY

Gleevec® (imatinib mesylate) film-coated tablets contain imatinib mesylate equivalent to 100 mg or 400 mg of imatinib free base.

Gleevec® (imatinib mesylate) is indicated for the treatment of newly diagnosed adult patients with Philadelphia chromosome positive chronic myeloid leukemia (CML) in chronic phase. Follow-up is limited.

Gleevec is also indicated for the treatment of patients with Philadelphia chromosome positive chronic myeloid leukemia (CML) in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. Gleevec is also indicated for the treatment of pediatric patients with Ph+ chronic phase CML whose disease has recurred after stem cell transplant or who are resistant to interferon-alpha therapy. There are no controlled trials in pediatric patients demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.

Gleevec is also indicated for the treatment of patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). (See CLINICAL STUDIES, Gastrointestinal Stromal Tumors.) The effectiveness of Gleevec in GIST is based on objective response rate (see CLINICAL STUDIES). There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.


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NEWS HIGHLIGHTS

Media Articles Related to Gleevec (Imatinib)

Study finds new drug is potent treatment for CML
Source: The Doctors Lounge - Hematology
AMN107, is about 20 times more potent than Gleevec and is effective in treating Gleevec-resistant disease.

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Published Studies Related to Gleevec (Imatinib)

Nilotinib versus imatinib for the treatment of patients with newly diagnosed chronic phase, Philadelphia chromosome-positive, chronic myeloid leukaemia: 24-month minimum follow-up of the phase 3 randomised ENESTnd trial. [2011.09]
BACKGROUND: Nilotinib has shown greater efficacy than imatinib in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukaemia (CML) in chronic phase after a minimum follow-up of 12 months. We present data from the Evaluating Nilotinib Efficacy and Safety in clinical Trials-newly diagnosed patients (ENESTnd) study after a minimum follow-up of 24 months... INTERPRETATION: Nilotinib continues to show better efficacy than imatinib for the treatment of patients with newly diagnosed CML in chronic phase. These results support nilotinib as a first-line treatment option for patients with newly diagnosed disease. FUNDING: Novartis. Copyright (c) 2011 Elsevier Ltd. All rights reserved.

Placental growth factor and soluble c-kit receptor dynamics characterize the cytokine signature of imatinib in prostate cancer and bone metastases. [2011.07]
To assess the hypothesis that the dynamics of plasma angiogenic and inflammatory cytokines after docetaxel chemotherapy with or without the c-kit/abl/platelet-derived growth factor receptor (PDGFR) inhibitor imatinib mesylate for prostate cancer are associated with outcome, the kinetics of 17 plasma cytokines before versus after chemotherapy were assessed and associations with progression-free survival (PFS) examined...

Imatinib as adjuvant therapy for gastrointestinal stromal tumors: a systematic review. [2011.05.01]
The high risk of recurrence in resected gastrointestinal stromal tumor (GIST) highlights the need for effective adjuvant treatment. This review evaluates the clinical efficacy and safety of imatinib for adjuvant treatment of localized KIT (CD117)-positive resected GIST... This study adds to the evidence (based on one RCT and a number of observational studies) that GIST patients treated with adjuvant imatinib therapy show an improvement in recurrence-free survival compared to placebo or no treatment after resection of KIT-positive localized GIST with tolerable toxicity.

Tolerability-adapted imatinib 800 mg/d versus 400 mg/d versus 400 mg/d plus interferon-alpha in newly diagnosed chronic myeloid leukemia. [2011.04.20]
PURPOSE: Treatment of chronic-phase (CP) chronic myeloid leukemia (CML) with imatinib 400 mg/d can be unsatisfactory. Optimization of treatment is warranted... CONCLUSION: Treatment of early-phase CML with imatinib can be optimized. Early high-dose therapy followed by rapid adaptation to good tolerability increases the rate of MMR at 12 months. Achievement of MMR by month 12 is directly associated with improved survival.

Neoadjuvant imatinib in patients with locally advanced non metastatic GIST in the prospective BFR14 trial. [2011.02.15]
BACKGROUND: The role of surgery in the management of patients with advanced gastrointestinal stromal tumors (GIST) in the era of imatinib mesylate (IM) remains debated. We analyzed the outcome of patients with non metastatic locally advanced primary GIST treated with IM within the prospective BFR14 phase III trial... CONCLUSIONS: Following neoadjuvant IM for non metastatic locally advanced GIST 9 of 25 patients (36%) were selected for resection of the primary tumor. OS and PFS figures were close to those of localised intermediate or high risk GIST (70% at 5 years) in the subgroup of operated patients, while the outcome of the non-operated subgroup was similar to that of metastatic GIST.

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Clinical Trials Related to Gleevec (Imatinib)

A Study of Gleevec in Patients With Idiopathic Myelofibrosis or Chronic Myelomonocytic Leukemia (CMML) [Active, not recruiting]
The purpose of this study is to determine the effects (good and bad) of Gleevec in patients with BCR-negative myeloproliferative disorders including myelofibrosis with myeloid metaplasia and chronic myelomonocytic leukemia.

Phase II Trial of Gleevec and Taxotere as a Combined Regimen for Advanced Gastric Adenocarcinoma [Terminated]
The purpose of this trial is to test the combination of GleevecŪ (also known as imatinib mesylate) and Taxotere (also known as docetaxel) in patients with incurable stomach cancer. This study is being performed to see if the combination of Gleevec and Taxotere is an effective treatment for incurable stomach cancer with minimal side effects.

Trial Evaluating Gleevec in Patients With Anaplastic Thyroid Carcinoma [Active, not recruiting]
Anaplastic thyroid cancers are rare, aggressive tumors. Standard treatment options include surgery and chemoradiation. Few treatment options are available once metastases develop. Recent data suggest that Imatinib (Gleevec) may be advantageous in this patient population. Patients who have been treated for anaplastic thyroid cancer with chemoradiation or surgery who develop recurrent or metastatic disease outside of the field of radiation are eligible. Patients will be treated with Imatinib 400 mg two times a day for eight weeks, followed by radiologic assessment. Patients will be treated until disease progression or a complete response is obtained.

GlivecŪ (Imatinib Mesylate, STI571) in Monotherapy Versus GlivecŪ-Interferon Alpha in the Treatment of Chronic-Phase Chronic Myeloid Leukaemia [Completed]
To compare the complete cytogenetic response rate in patients with newly-diagnosed chronic-phase chronic myeloid leukaemia treated with GlivecŪ alone or in combination with interferon at low doses

Imatinib Mesylate (Gleevec) and Docetaxel in Patients With Head and Neck Squamous Cell Cancer [Active, not recruiting]
Primary Objective:

1. To determine the efficacy of the combination of imatinib mesylate and docetaxel in recurrent or metastatic head and neck squamous cell cancer by serial measurements of tumor response (extent, frequency, duration).

Secondary Objectives:

1. To assess the safety and tolerability of imatinib mesylate and docetaxel in patients with recurrent or metastatic head and neck squamous cell cancer.

2. To explore the biologic effects of imatinib mesylate and docetaxel on tumor tissue by immunohistochemical analysis of microvessel density and phosphorylation of PDGF-R.

3. To explore the effects of imatinib mesylate and docetaxel on surrogate markers in serum.

4. To assess the rate of survival.

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Reports of Suspected Gleevec (Imatinib) Side Effects

Death (892)Neoplasm Malignant (294)Nausea (223)Diarrhoea (189)Vomiting (170)Fatigue (165)Anaemia (146)Oedema Peripheral (116)Dyspnoea (116)Pyrexia (108)more >>


Page last updated: 2011-12-09

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