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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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A Trial of Imatinib for Patients With Aggressive Desmoid Tumor (Aggressive Fibromatosis)

Phase 2
Completed
Conditions
Fibromatosis
Interventions
First Posted Date
2015-07-13
Last Posted Date
2020-01-14
Lead Sponsor
Yonsei University
Target Recruit Count
21
Registration Number
NCT02495519
Locations
🇰🇷

Severance Hospital, Yonsei University Health System, Seoul, Korea, Republic of

Treatment of CML Patients With Imatinib and Hydroxyurea (CML2004)

Phase 1
Completed
Conditions
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Interventions
First Posted Date
2015-06-24
Last Posted Date
2015-06-24
Lead Sponsor
University of Leipzig
Target Recruit Count
113
Registration Number
NCT02480608

Brentuximab Vedotin and Imatinib in Patients With Relapsed or Refractory ALK+ ALCL

Phase 1
Terminated
Conditions
ALK+ Anaplastic Large Cell Lymphoma
Interventions
First Posted Date
2015-06-04
Last Posted Date
2022-03-03
Lead Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
Target Recruit Count
3
Registration Number
NCT02462538
Locations
🇦🇹

Universitätsklinik f. Innere Medizin I, AKH Wien, Klinische Abteilung für Hämatologie und Hämostaseologie, Wien, Austria

Patients With Refractory, Metastatic Cancer Harboring KIT Mutation or Amplification to Investigate the Clinical Efficacy and Safety of Imatinib Therapy

Phase 2
Conditions
Advanced, Refractory Cancer
Interventions
First Posted Date
2015-06-03
Last Posted Date
2022-06-15
Lead Sponsor
Samsung Medical Center
Target Recruit Count
14
Registration Number
NCT02461849
Locations
🇰🇷

Samsung Medical Center, Seoul, Korea, Republic of

Three Versus Five Years of Adjuvant Imatinib as Treatment of Patients With Operable GIST

Phase 3
Active, not recruiting
Conditions
Sarcoma
Interventions
First Posted Date
2015-04-10
Last Posted Date
2023-11-09
Lead Sponsor
Heikki Joensuu
Target Recruit Count
255
Registration Number
NCT02413736
Locations
🇫🇮

Helsinki University Central Hospital, Helsinki, Finland

A Randomised Trial of Imatinib Alternating With Regorafenib Compared to Imatinib Alone for the First Line Treatment of Advanced Gastrointestinal Stromal Tumour (GIST)

Phase 2
Active, not recruiting
Conditions
Gastrointestinal Stromal Tumour
Interventions
First Posted Date
2015-02-19
Last Posted Date
2023-07-07
Lead Sponsor
Australasian Gastro-Intestinal Trials Group
Target Recruit Count
78
Registration Number
NCT02365441
Locations
🇦🇺

Prince of Wales Hospital, Sydney, New South Wales, Australia

🇦🇺

Flinders Medical Centre, Adelaide, South Australia, Australia

🇦🇺

Sir Charles Gairdner, Perth, Western Australia, Australia

and more 22 locations

Treatment of Cervical Spinal Cord Injury With Imatinib - a Safety and Feasibility Study

Phase 2
Conditions
Cervical Spinal Cord Injury
Interventions
First Posted Date
2015-02-16
Last Posted Date
2018-03-07
Lead Sponsor
Professor Mikael Svensson, MD PhD
Target Recruit Count
10
Registration Number
NCT02363361

A Study of BBI608 in Adult Patients With Advanced, Refractory Hematologic Malignancies

Phase 1
Completed
Conditions
Hematologic Malignancy
Interventions
First Posted Date
2015-02-02
Last Posted Date
2023-11-14
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
15
Registration Number
NCT02352558
Locations
🇺🇸

Virginia Oncology Associates, Norfolk, Virginia, United States

🇺🇸

West Clinic, Germantown, Tennessee, United States

🇺🇸

Northwest Cancer Specialists, PC, Vancouver, Washington, United States

and more 5 locations

Optimization of TKIs Treatment and Quality of Life in Ph+ CML Patients ≥60 Years in Deep Molecular Response

Phase 3
Completed
Conditions
Leukemia, Chronic Myeloid
Interventions
First Posted Date
2014-12-29
Last Posted Date
2024-08-13
Lead Sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Target Recruit Count
229
Registration Number
NCT02326311
Locations
🇮🇹

Policlinico Universitario di Milano, Milano, Italy

Efficacy and Safety of Imatinib Mesylate as First-line Treatment for the Patients With Chronic Phase of Chronic Myeloid Leukemia

Phase 4
Conditions
Chronic Myeloid Leukemia
Interventions
First Posted Date
2014-12-15
Last Posted Date
2014-12-15
Lead Sponsor
Cttq
Target Recruit Count
90
Registration Number
NCT02317159
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