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 HIGHLIGHTSMedia 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.
ChemGenex Announces FDA Accepts NDA For Omapro™ (Omacetaxine Mepesuccinate) And Grants The Filing Priority Review Status
Source: Blood / Hematology News From Medical News Today [2009.11.10]
ChemGenex Pharmaceuticals Limited (ASX:CXS) announced today that the U.S. Food & Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for Omapro™ (omacetaxine mepesuccinate) for the treatment of patients with chronic myeloid leukemia (CML) who have failed treatment with imatinib and who have developed the Bcr-Abl T315I mutation. The NDA has also been granted Priority Review.
Published Studies Related to Gleevec (Imatinib)
Dasatinib or high-dose imatinib for chronic-phase chronic myeloid leukemia resistant to imatinib at a dose of 400 to 600 milligrams daily: two-year follow-up of a randomized phase 2 study (START-R). [2009.09.15]
BACKGROUND: In patients with chronic-phase chronic myeloid leukemia (CP-CML), imatinib resistance is of increasing importance. Imatinib dose escalation was the main treatment option before dasatinib, which has 325-fold more potent inhibition than imatinib against unmutated Bcr-Abl in vitro. Data with a minimum of 2 years of follow-up were available for the current study of dasatinib and high-dose imatinib in CP-CML resistant to imatinib at daily doses from 400 mg to 600 mg... CONCLUSIONS: After 2 years of follow-up, dasatinib demonstrated durable responses and improved response and progression-free survival rates relative to high-dose imatinib. Copyright (c) 2009 American Cancer Society.
Absence of progression as assessed by response evaluation criteria in solid tumors predicts survival in advanced GI stromal tumors treated with imatinib mesylate: the intergroup EORTC-ISG-AGITG phase III trial. [2009.08.20]
PURPOSE: From February 2001 to February 2002, 946 patients with advanced GI stromal tumors (GISTs) treated with imatinib were included in a controlled EORTC/ISG/AGITG (European Organisation for Research and Treatment of Cancer/Italian Sarcoma Group/Australasian Gastro-Intestinal Trials Group) trial. This analysis investigates whether the response classification assessed by RECIST (Response Evaluation Criteria in Solid Tumors), predicts for time to progression (TTP) and overall survival (OS)... CONCLUSION: RECIST perfectly enables early discrimination between patients who benefited long term from imatinib and those who did not. After 6 months of imatinib, if the patient is not experiencing PD, the pattern of radiologic response by tumor size criteria has no prognostic value for further outcome. Imatinib needs to be continued as long as there is no progression according to RECIST.
Imatinib plasma levels are correlated with clinical benefit in patients with unresectable/metastatic gastrointestinal stromal tumors. [2009.07.01]
PURPOSE To study the pharmacokinetics (PK) of imatinib (IM) in patients with advanced GI stromal tumors (GISTs) treated in a randomized phase II study and to explore the potential relationship between IM plasma levels and long-term clinical outcomes... Further studies are justified to test whether monitoring IM plasma levels might optimize clinical outcomes for patients with GIST.
Clinical evaluation of continuous daily dosing of sunitinib malate in patients with advanced gastrointestinal stromal tumour after imatinib failure. [2009.07]
AIMS: To assess the antitumour activity, safety, pharmacokinetics and pharmacodynamics of continuous daily sunitinib dosing in patients with imatinib-resistant/intolerant gastrointestinal stromal tumour (GIST) and to assess morning dosing versus evening dosing... CONCLUSION: For patients with imatinib-resistant/intolerant GIST, continuous daily sunitinib dosing appears to be an active alternative dosing strategy with acceptable safety.
Phase 3 study of dasatinib 140 mg once daily versus 70 mg twice daily in patients with chronic myeloid leukemia in accelerated phase resistant or intolerant to imatinib: 15-month median follow-up. [2009.06.18]
Dasatinib is the most potent BCR-ABL inhibitor, with 325-fold higher potency than imatinib against unmutated BCR-ABL in vitro. Studies have demonstrated the benefits of dasatinib 70 mg twice daily in patients with accelerated-phase chronic myeloid leukemia intolerant or resistant to imatinib... This trial is registered at www.clinicaltrials.gov as #CA180-035.
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 Gleevec® (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.
Glivec� (Imatinib Mesylate, STI571) in Monotherapy Versus Glivec�-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 Glivec® 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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