Molecular Profile Detail

Profile Name IDH1 mutant
Gene Variant Detail

IDH1 mutant (unknown)

Relevant Treatment Approaches

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Molecular Profile Indication/Tumor Type Response Type Relevant Treatment Approaches Therapy Name Approval Status Evidence Type Efficacy Evidence References
IDH1 mutant oligodendroglioma not applicable N/A Guideline Diagnostic IDH1 mutations aid in the diagnosis of oligodendrogliomas (NCCN.org). detail...
IDH1 mutant acute myeloid leukemia predicted - sensitive Venetoclax Phase II Actionable In a Phase II trial, 33% (4/12) of acute myeloid leukemia patients harboring either IDH1 or IDH2 mutations responded to treatment with Venclexta (venetoclax), demonstrating a complete response or complete response with incomplete blood count recovery (PMID: 27520294). 27520294
IDH1 mutant myelofibrosis not applicable N/A Guideline Prognostic IDH1 mutations are associated with inferior leukemia-free survival in patients with myelofibrosis (NCCN.org). detail...
IDH1 mutant acute myeloid leukemia sensitive Ivosidenib FDA approved Actionable In a Phase I trial that supported FDA approval, Tibsovo (ivosidenib) treatment was well-tolerated and resulted in complete remission (CR) in 21.6% (27/125), complete remission with partial hematological recovery (CRh) in 8.8% (11/125), and overall response (OR) in 41.6% (52/125) of patients with relapsed or refractory acute myeloid leukemia harboring an IDH1 mutation, with a median duration of response of 8.2 months for CR+CRh, 9.3 months for CR, and 6.5 months for OR (PMID: 29860938; NCT02074839). detail... 29860938
IDH1 mutant lung adenocarcinoma resistant Dasatinib Preclinical Actionable In a preclinical study, lung adenocarcinoma cells harboring IDH1 mutations were resistant to Sprycel (dasatinib) in culture (PMID: 27231123). 27231123
IDH1 mutant malignant glioma not applicable N/A Guideline Prognostic IDH1 mutations are associated with a favorable prognosis in patients with glioma, and are associated with a survival benefit for patients treated with radiation or alkylator therapy (NCCN.org). detail...
IDH1 mutant malignant glioma not applicable N/A Guideline Diagnostic IDH1 mutations aid in the diagnosis of gliomas (NCCN.org). detail... 23041832 19755387 19915484
IDH1 mutant malignant glioma not applicable N/A Clinical Study Prognostic In multiple clinical studies, including two meta-analyses, IDH1 mutations were associated with improved overall survival and progression free survival in patients with gliomas (PMID: 23817809, PMID: 26220714, PMID: 23894344). 23894344 23817809 26220714
IDH1 mutant glioblastoma multiforme predicted - sensitive Bevacizumab + Lomustine Phase II Actionable In a retrospective analysis of a Phase II trial, IDH1 mutation correlated with favorable overall survival in recurrent glioblastoma patients treated with a combination of Avastin (bevacizumab) and Lomustine (PMID: 26762204). 26762204
IDH1 mutant astrocytoma not applicable N/A Guideline Diagnostic IDH1 mutations aid in the diagnosis of grade II and grade III astrocytomas (NCCN.org). detail...
IDH1 mutant grade III astrocytoma not applicable N/A Guideline Diagnostic IDH1 mutations aid in the diagnosis of grade III astrocytomas (NCCN.org). detail...
IDH1 mutant acute myeloid leukemia not applicable N/A Clinical Study Prognostic In two meta-analyses, IDH1 mutations were associated with a worse overall survival in patients with acute myeloid leukemia (PMID: 22616558, PMID: 23226625). 22616558 23226625
IDH1 mutant glioblastoma multiforme not applicable N/A Guideline Diagnostic IDH1 mutations aid in the diagnosis of secondary grade IV glioblastomas (NCCN.org). detail...
IDH1 mutant glioblastoma multiforme not applicable N/A Clinical Study Prognostic In multiple clinical studies, including two meta-analyses, IDH1 mutations were associated with a greater overall survival and progression-free survival in patients with glioblastoma (PMID: 23904262, PMID: 26945349, PMID: 20560678). 20560678 23904262 26945349
IDH1 mutant cholangiocarcinoma sensitive Ivosidenib Phase I Actionable In a Phase I trial, AG-120 treatment resulted in partial response in 6% (4/72) and stable disease in 56% (40/72) of cholangiocarcinoma patients harboring IDH1 mutations (Journal of Clinical Oncology 35, no. 15_suppl (May 2017) 4015-4015; NCT02073994). detail...
IDH1 mutant acute myeloid leukemia predicted - sensitive Cytarabine + Venetoclax Phase Ib/II Actionable In a Phase I/II trial, Venclexta (venetoclax) in combination with low-dose cytarabine resulted in complete remission or complete remission with incomplete count recovery in 72% (13/18) of patients with acute myeloid leukemia harboring IDH1 or IDH2 mutations who were ineligible for intensive chemotherapy (ASH Annual Meeting, Dec 2018, Abstract 284; NCT02287233). detail...
IDH1 mutant chondrosarcoma resistant Dasatinib Preclinical Actionable In a preclinical study, chondrosarcoma cells harboring IDH1 mutations were resistant to Sprycel (dasatinib) in culture (PMID: 27231123). 27231123
IDH1 mutant malignant glioma sensitive Ivosidenib Phase I Actionable In a Phase I trial, AG-120 demonstrated safety and preliminary efficacy in IDH1-mutant glioma patients (Neuro Oncol (2016) 18 (suppl 6): vi12). detail...
Clinical Trial Phase Therapies Title Recruitment Status
NCT02632708 Phase I Ivosidenib Enasidenib Cytarabine + Daunorubicin + Etoposide + Mitoxantrone Safety Study of AG-120 or AG-221 in Combination With Induction and Consolidation Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia With an IDH1 and/or IDH2 Mutation Active, not recruiting
NCT02981940 Phase II Abemaciclib A Study of Abemaciclib in Recurrent Glioblastoma Active, not recruiting
NCT02074839 Phase I Ivosidenib Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation Active, not recruiting
NCT03212274 Phase II Olaparib Olaparib in Treating Patients With Advanced Glioma, Cholangiocarcinoma, or Solid Tumors With IDH1 or IDH2 Mutations Recruiting
NCT03718767 Phase II Nivolumab Nivolumab in People With IDH-Mutant Gliomas With and Without Hypermutator Phenotype Not yet recruiting
NCT02071862 Phase I CB-839 Study of the Glutaminase Inhibitor CB-839 in Solid Tumors Active, not recruiting
NCT02968940 Phase III Avelumab Avelumab With Hypofractionated Radiation Therapy in Adults With Isocitrate Dehydrogenase (IDH) Mutant Glioblastoma Active, not recruiting
NCT03430791 Phase II Nivolumab + Ipilimumab Nivolumab Trial of Combination TTF(Optune), Nivolumab Plus/Minus Ipilimumab for Bevacizumab-naïve, Recurrent Glioblastoma Recruiting
NCT02989857 Phase III Ivosidenib Study of AG-120 in Previously Treated Advanced Cholangiocarcinoma With IDH1 Mutations (ClarIDHy) Active, not recruiting
NCT02073994 Phase I Ivosidenib Study of Orally Administered AG-120 in Subjects With Advanced Solid Tumors, Including Glioma, With an IDH1 Mutation Active, not recruiting
NCT02428855 Phase II Dasatinib Phase II Trial of Dasatinib in Patients With Isocitrate Dehydrogenase (IDH)-Mutant Advanced Intrahepatic Cholangiocarcinoma Completed
NCT02677922 Phase Ib/II Azacitidine + Ivosidenib Azacitidine Azacitidine + Enasidenib A Safety and Efficacy Study of Oral AG-120 Plus Subcutaneous Azacitidine and Oral AG-221 Plus Subcutaneous Azacitidine in Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML) Active, not recruiting
NCT03749187 Phase I Pamiparib + Temozolomide BGB-290 and Temozolomide in Treating Isocitrate Dehydrogenase (IDH)1/2-Mutant Grade I-IV Gliomas (PNOC017) Not yet recruiting
NCT03557359 Phase II Nivolumab Nivolumab for Recurrent or Progressive IDH Mutant Gliomas Recruiting
NCT03173248 Phase III Azacitidine + Ivosidenib Ivosidenib Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Patients With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation (AGILE) Recruiting
NCT02858895 Phase II MDNA55 Convection-Enhanced Delivery (CED) of MDNA55 in Adults With Recurrent or Progressive Glioblastoma Recruiting
NCT02481154 Phase I AG-881 Study of Orally Administered AG-881 in Patients With Advanced Solid Tumors, Including Gliomas, With an IDH1 and/or IDH2 Mutation Active, not recruiting
NCT03127735 Phase I BAY1436032 BAY1436032 in Patients With Mutant IDH1(mIDH1) Advanced Acute Myeloid Leukemia (AML) Active, not recruiting
NCT03207347 Phase II Niraparib A Trial of Niraparib in BAP1 and Other DNA Double-Strand Break Repair Deficient Neoplasms (UF-STO-ETI-001) Recruiting
NCT02492737 Phase I AG-881 Study of Orally Administered AG-881 in Patients With Advanced Hematologic Malignancies With an IDH1 and/or IDH2 Mutation Completed
NCT02525692 Phase II ONC201 Oral ONC201 in Adult Recurrent Glioblastoma Recruiting
NCT03220646 Phase II Abemaciclib The Purpose of This Study is to Test Any Good and Bad Effects of a Study Drug Called Abemaciclib (LY2835219) in Patients With Recurrent Brain Tumors. Recruiting