Ivosidenib
Information
- Drug Name
- Ivosidenib
- Description
- Entry(CIViC)
- 4
CIViC
| Disease | Mutation | EL | ET | ED | CS | VO | TR | Pubmed | Links |
|---|---|---|---|---|---|---|---|---|---|
| acute myeloid leukemia |
IDH1 p.Arg132Cys (p.R132C) ( ENST00000345146.7, ENST00000446179.5, ENST00000415913.5 ) IDH1 p.Arg132Cys (p.R132C) ( ENST00000345146.7, ENST00000415913.5, ENST00000446179.5 ) |
B |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 2 | 25583779 | Detail |
| pancreatic ductal adenocarcinoma |
IDH1 p.Arg132His (p.R132H) ( ENST00000345146.7, ENST00000415913.5, ENST00000446179.5 ) IDH1 p.Arg132His (p.R132H) ( ENST00000345146.7, ENST00000415913.5, ENST00000446179.5 ) |
C |
Predictive
|
Does Not Support
|
Sensitivity/Response | Somatic | 2 | 27466707 | Detail |
| acute myeloid leukemia | IDH1 MUTATION IDH1 MUTATION | A |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 3 | 29860938 | Detail |
| cholangiocarcinoma | IDH1 MUTATION IDH1 MUTATION | B |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 3 | 31300360 | Detail |
Annotation
| Description | Associated Genes | Associated Variants | Sensitivity | Supported | Source | Links |
|---|---|---|---|---|---|---|
| In a clinical study of 17 relapsed or refractory A... | IDH1 |
IDH1 p.Arg132Cys (p.R132C) ( ENST00000345146.7, ENST00000446179.5, ENST00000415913.5 ) IDH1 p.Arg132Cys (p.R132C) ( ENST00000345146.7, ENST00000415913.5, ENST00000446179.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| A 48-year-old female was diagnosed with metastatic... | IDH1 |
IDH1 p.Arg132His (p.R132H) ( ENST00000345146.7, ENST00000415913.5, ENST00000446179.5 ) IDH1 p.Arg132His (p.R132H) ( ENST00000345146.7, ENST00000415913.5, ENST00000446179.5 ) |
Sensitivity | false | CIViC Evidence | detail |
| I phase 1 trial for patients with IDH1-mutated AML... | IDH1 | IDH1 MUTATION IDH1 MUTATION | Sensitivity | true | CIViC Evidence | detail |
| In a phase1 trial, 73 patients with cholangiocarci... | IDH1 | IDH1 MUTATION IDH1 MUTATION | Sensitivity | true | CIViC Evidence | detail |
| NCT ID | Status | Phase | Summary | Start date | Completion date |
|---|---|---|---|---|---|
| NCT03498521 | Active, not recruiting | Phase 2 | A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site | July 10, 2018 | June 9, 2024 |
| NCT06081829 | Active, not recruiting | Phase 2 | A Phase 2 Study of Ivosidenib in Previously Treated Japanese Subjects With Nonresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation | October 10, 2023 | May 2027 |
| NCT04195555 | Active, not recruiting | Phase 2 | Ivosidenib in Treating Patients With Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With IDH1 Mutations (A Pediatric MATCH Treatment Trial) | July 20, 2020 | December 31, 2025 |
| NCT03564821 | Completed | Phase 1 | IDH1 Inhibition Using Ivosidenib as Maintenance Therapy for IDH1-mutant Myeloid Neoplasms Following Allogeneic Stem Cell Transplantation | January 16, 2019 | June 6, 2023 |
| NCT04176393 | Completed | Phase 1 | A China Bridging Study of Ivosidenib in r/r AML Subjects With an IDH1 Mutation | November 12, 2019 | January 18, 2023 |
| NCT06291987 | Not yet recruiting | Phase 1 | Ivosidenib and Ruxolitinib in Patients With Advanced Myeloproliferative Neoplasms (MPNs) That Have an IDH1 Gene Mutation | May 20, 2024 | May 2026 |
| NCT05030441 | Recruiting | Phase 2 | Ivosidenib for Patients With Clonal Cytopenia of Undetermined Significance and Mutations in IDH1 | April 1, 2022 | June 30, 2026 |
| NCT05209074 | Recruiting | Phase 1 | Ivosidenib + mFOLFIRINOX in Patients With Resectable Pancreatic Adenocarcinoma | September 8, 2022 | October 15, 2024 |
| NCT05401097 | Recruiting | Phase 2 | IDH Targeted/Non- Targeted vs Non-targeted/IDH-targeted Approaches in the Treatment of Newly Diagnosed IDH Mutated AML Patients Not Candidates for Intensive Induction Therapy (I- DATA Study) | September 13, 2022 | June 30, 2027 |
| NCT05615818 | Recruiting | Phase 3 | Personalized Medicine for Advanced Biliary Cancer Patients | May 29, 2024 | June 2028 |
| NCT05756777 | Recruiting | Phase 1 | A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML) | June 26, 2023 | February 2025 |
| NCT05921760 | Recruiting | Phase 1/Phase 2 | Ivosidenib, Nivolumab, and Ipilimumab Combination in Previously Treated Subjects With Nonresectable or Metastatic IDH1 Mutant Cholangiocarcinoma | October 23, 2023 | March 2026 |
| NCT04955938 | Recruiting | Phase 1 | A Study of Fedratinib With IDH Inhibition in Advanced-Phase, IDH-Mutated Ph-Negative Myeloproliferative Neoplasms | October 29, 2021 | October 1, 2025 |
| NCT04250051 | Recruiting | Phase 1 | Ivosidenib and Combination Chemotherapy for the Treatment of IDH1 Mutant Relapsed or Refractory Acute Myeloid Leukemia | December 21, 2020 | December 1, 2028 |
| NCT04493164 | Recruiting | Phase 2 | CPX-351 and Ivosidenib for the Treatment of IDH1 Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome | December 30, 2020 | June 1, 2025 |
| NCT04774393 | Recruiting | Phase 1/Phase 2 | Decitabine/Cedazuridine and Venetoclax in Combination With Ivosidenib or Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia | May 24, 2021 | November 29, 2024 |
| NCT03471260 | Recruiting | Phase 1/Phase 2 | Ivosidenib and Venetoclax With or Without Azacitidine in Treating Patients With IDH1 Mutated Hematologic Malignancies | March 19, 2018 | September 30, 2025 |
| NCT05010772 | Recruiting | Phase 1 | Decitabine Alone or in Combination With Venetoclax, Gilteritinib, Enasidenib, or Ivosidenib as Maintenance Therapy for the Treatment of Acute Myeloid Leukemia in Remission | October 25, 2021 | December 31, 2026 |
| NCT06181734 | Recruiting | Ivosidenib (TIBSOVO®) Combined With Azacitidine According to Current SmPC | December 20, 2023 | June 30, 2028 | |
| NCT04088188 | Terminated | Phase 1 | Gemcitabine and Cisplatin With Ivosidenib or Pemigatinib for the Treatment of Unresectable or Metastatic Cholangiocarcinoma | January 25, 2021 | December 1, 2023 |
| NCT04655391 | Withdrawn | Phase 1 | Glasdegib-Based Treatment Combinations for the Treatment of Patients With Relapsed Acute Myeloid Leukemia Who Have Undergone Hematopoietic Cell Transplantation | June 25, 2022 | December 15, 2023 |