MedPath

Imatinib

Generic Name
Imatinib
Brand Names
Gleevec, Glivec, Imatinib Teva, Imatinib Accord
Drug Type
Small Molecule
Chemical Formula
C29H31N7O
CAS Number
152459-95-5
Unique Ingredient Identifier
BKJ8M8G5HI
Background

Imatinib is a small molecule kinase inhibitor that revolutionized the treatment of cancer, particularly chronic myeloid leukemia, in 2001. It was deemed a "miracle drug" due to its clinical success, as oncologist Dr. Brian noted that "complete hematologic responses were observed in 53 of 54 patients with CML treated with a daily dosage of 300 mg or more and typically occurred in the first four weeks of therapy".. The discovery of imatinib also established a new group of therapy called "targeted therapy", since treatment can be tailored specifically to the unique cancer genetics of each patient.

Indication

Imatinib is indicated for the treatment of adult and pediatric chronic myeloid leukemia with Philadelphia chromosome mutation (Ph+) in blast crisis, accelerated phase, or chronic phase after IFN-alpha therapy failure.Additionally, imatinib is also indicated to treat adult and pediatric Ph+ acute lymphoblastic leukemia, adult myelodysplastic/myeloproliferative diseases, adult aggressive systemic mastocytosis, adult hypereosinophilic syndrome and/or chronic eosinophilic leukemia (CEL), adult dermatofibrosarcoma protuberans, and malignant gastrointestinal stromal tumors (GIST).

Associated Conditions
Accelerated Phase Chronic Myelogenous Leukemia (CML), Aggressive Systemic Mastocytosis, Chordomas, Chronic Eosinophilic Leukemia, FIP1L1-PDGFRα fusion kinase status unknown Chronic eosinophilic leukemia, FIP1L1-PDGFRα fusion kinase status unknown Hypereosinophilic syndrome, Gastrointestinal Stromal Tumor (GIST), Hypereosinophilic Syndrome (HES), Metastatic Gastrointestinal Stromal Tumor (GIST), Metastatic Melanoma, Myelodysplastic Syndrome, Myeloproliferative Disorders (MPD), Refractory Acute Lymphoblastic Leukemia (ALL), Blast phase Chronic myeloid leukemia, CKit mutational status unknown Aggressive systemic mastocytosis, Metastatic Dermatofibrosarcoma protuberans, Newly diagnosed Acute Lymphoblastic Leukaemia, Newly diagnosed, chronic phase Chronic myeloid leukemia, Recurrent Dermatofibrosarcoma protuberans, Refractory, chronic phase Chronic myeloid leukemia, Unresectable Gastrointestinal stromal tumor
Associated Therapies
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High-Dose Gleevec Alone or in Combination With Peg-Intron and GM-CSF in Early Phase Chronic Myelogenous Leukemia (CML)

Phase 3
Completed
Conditions
Leukemia, Myeloid, Chronic
Interventions
Drug: Gleevec
Drug: Peg-alpha interferon (Peg-Intron)
Drug: Sargramostim (GM-CSF)
First Posted Date
2003-02-07
Last Posted Date
2016-05-11
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
94
Registration Number
NCT00050531
Locations
🇺🇸

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Imatinib Mesylate and Decitabine in Treating Patients With Chronic Myelogenous Leukemia

Phase 2
Completed
Conditions
Accelerated Phase Chronic Myelogenous Leukemia
Blastic Phase Chronic Myelogenous Leukemia
Childhood Chronic Myelogenous Leukemia
Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Relapsing Chronic Myelogenous Leukemia
Interventions
Drug: imatinib mesylate
Drug: decitabine
Other: laboratory biomarker analysis
First Posted Date
2003-02-06
Last Posted Date
2013-01-23
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
80
Registration Number
NCT00054431
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Imatinib Mesylate in Treating Patients With Primary Gastrointestinal Stromal Tumor That Has Been Completely Removed By Surgery

Phase 3
Completed
Conditions
Gastrointestinal Stromal Tumor
Interventions
Drug: imatinib mesylate
Other: placebo
Other: laboratory biomarker analysis
First Posted Date
2003-01-27
Last Posted Date
2013-07-16
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
732
Registration Number
NCT00041197
Locations
🇺🇸

American College of Surgeons Oncology Group, Durham, North Carolina, United States

Imatinib Mesylate in Treating Patients With Gastrointestinal Stromal Tumor That Has Been Completely Removed During Surgery

Phase 2
Completed
Conditions
Gastrointestinal Stromal Tumor
Interventions
Drug: imatinib mesylate
Other: laboratory biomarker analysis
First Posted Date
2003-01-27
Last Posted Date
2013-02-20
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
89
Registration Number
NCT00025246
Locations
🇺🇸

American College of Surgeons Oncology Group, Durham, North Carolina, United States

Imatinib Mesylate in Treating Patients With Advanced Cancer and Liver Dysfunction

Phase 1
Completed
Conditions
Accelerated Phase Chronic Myelogenous Leukemia
Acute Undifferentiated Leukemia
AIDS-related Peripheral/Systemic Lymphoma
AIDS-related Primary CNS Lymphoma
Anaplastic Large Cell Lymphoma
Angioimmunoblastic T-cell Lymphoma
Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
Blastic Phase Chronic Myelogenous Leukemia
Childhood Myelodysplastic Syndromes
Chronic Eosinophilic Leukemia
Interventions
Drug: imatinib mesylate
Other: pharmacological study
First Posted Date
2003-01-27
Last Posted Date
2013-02-07
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
60
Registration Number
NCT00025415
Locations
🇺🇸

University of Pittsburgh, Pittsburgh, Pennsylvania, United States

Imatinib Mesylate in Treating Patients With Stage IV Colorectal Cancer

Phase 2
Completed
Conditions
Recurrent Colon Cancer
Recurrent Rectal Cancer
Stage IV Colon Cancer
Stage IV Rectal Cancer
Interventions
Drug: imatinib mesylate
Other: laboratory biomarker analysis
First Posted Date
2003-01-27
Last Posted Date
2013-01-23
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
37
Registration Number
NCT00041340
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Imatinib Mesylate in Treating Patients With Metastatic Breast Cancer

Phase 2
Completed
Conditions
Male Breast Cancer
Recurrent Breast Cancer
Stage IV Breast Cancer
Interventions
Drug: imatinib mesylate
Other: laboratory biomarker analysis
First Posted Date
2003-01-27
Last Posted Date
2013-01-23
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
35
Registration Number
NCT00045188
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia

Phase 2
Completed
Conditions
Childhood Chronic Myelogenous Leukemia
Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Chronic Phase Chronic Myelogenous Leukemia
Interventions
Drug: imatinib mesylate
Other: laboratory biomarker analysis
Other: pharmacological study
First Posted Date
2003-01-27
Last Posted Date
2013-01-17
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
64
Registration Number
NCT00030394
Locations
🇺🇸

Children's Oncology Group, Arcadia, California, United States

Imatinib Mesylate in Treating Patients With Progressive, Refractory, or Recurrent Stage II or Stage III Testicular or Ovarian Cancer

Phase 2
Terminated
Conditions
Ovarian Dysgerminoma
Recurrent Malignant Testicular Germ Cell Tumor
Recurrent Ovarian Germ Cell Tumor
Stage II Malignant Testicular Germ Cell Tumor
Stage II Ovarian Germ Cell Tumor
Stage III Malignant Testicular Germ Cell Tumor
Stage III Ovarian Germ Cell Tumor
Testicular Seminoma
Interventions
Drug: imatinib mesylate
Procedure: therapeutic conventional surgery
Other: laboratory biomarker analysis
First Posted Date
2003-01-27
Last Posted Date
2013-01-17
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
32
Registration Number
NCT00042952
Locations
🇺🇸

Cancer and Leukemia Group B, Chicago, Illinois, United States

Imatinib Mesylate in Treating Patients With Advanced Cancer and Kidney Failure

Phase 1
Completed
Conditions
Malignant Neoplasm
Unspecified Adult Solid Tumor, Protocol Specific
Interventions
Drug: imatinib mesylate
Other: laboratory biomarker analysis
Other: pharmacological study
First Posted Date
2003-01-27
Last Posted Date
2013-01-10
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
69
Registration Number
NCT00026169
Locations
🇺🇸

Case Western Reserve University, Cleveland, Ohio, United States

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