Ivosidenib
- Generic Name
- Ivosidenib
- Brand Names
- Tibsovo
- Drug Type
- Small Molecule
- Chemical Formula
- C28H22ClF3N6O3
- CAS Number
- 1448347-49-6
- Unique Ingredient Identifier
- Q2PCN8MAM6
- Background
Ivosidenib is a first-in-class isocitrate dehydrogenase-1 (IDH1) inhibitor. IDH1 is an enzyme that is often mutated and overexpressed in some cancers, leading to aberrant cell growth and proliferation. Ivosidenib inhibits mutated IDH1, blocking the enzymatic activity and further differentiation of cancer cells.
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- Indication
Ivosidenib is an isocitrate dehydrogenase-1 (IDH1) inhibitor approved for use in the US and Europe. It is indicated for the treatment of patients with a susceptible IDH1 mutation with:
- Associated Conditions
- Acute Myeloid Leukemia, Locally Advanced Cholangiocarcinoma, Metastatic Cholangiocarcinoma, Refractory Acute Myeloid Leukemia (AML), Relapsed Acute Myelogenous Leukemia (AML)
- Associated Therapies
- -
Ivosidenib As Post-HSCT Maintenance for AML
- Conditions
- Interventions
- First Posted Date
- 2024-11-27
- Last Posted Date
- 2024-11-27
- Lead Sponsor
- Massachusetts General Hospital
- Target Recruit Count
- 75
- Registration Number
- NCT06707493
- Locations
- 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸Dana Farber Cancer Institute, Boston, Massachusetts, United States
Ivosidenib Plus Durvalumab and Gemcitabine/Cisplatin as First-Line Therapy in Participants With Locally Advanced or Metastatic Cholangiocarcinoma With an IDH1 Mutation
- Conditions
- Interventions
- First Posted Date
- 2024-07-15
- Last Posted Date
- 2024-07-15
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Target Recruit Count
- 52
- Registration Number
- NCT06501625
Ivosidenib (IVO) Monotherapy and Azacitidine (AZA) Monotherapy in Patients With Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) With an IDH1 Mutation
- Conditions
- Interventions
- First Posted Date
- 2024-06-20
- Last Posted Date
- 2024-12-10
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Target Recruit Count
- 48
- Registration Number
- NCT06465953
- Locations
- 🇯🇵
University of Fukui Hospital, Yoshida-gun, Eiheiji-cho 670-8540 Himeji, Japan
Ivosidenib and Ruxolitinib in Patients With Advanced Myeloproliferative Neoplasms (MPNs) That Have an IDH1 Gene Mutation
- Conditions
- Interventions
- First Posted Date
- 2024-03-04
- Last Posted Date
- 2024-10-16
- Lead Sponsor
- University of Chicago
- Target Recruit Count
- 18
- Registration Number
- NCT06291987
- Locations
- 🇺🇸
University of Chicago Medicine Comprehensive Cancer Center, Chicago, Illinois, United States
Ivosidenib (TIBSOVO®) Combined With Azacitidine According to Current SmPC
- Conditions
- First Posted Date
- 2023-12-26
- Last Posted Date
- 2024-06-24
- Lead Sponsor
- iOMEDICO AG
- Target Recruit Count
- 100
- Registration Number
- NCT06181734
- Locations
- 🇩🇪
Praxis für interdisziplinäre Onkologie & Hämatologie, Freiburg, Germany
A Phase 2 Study of Ivosidenib in Previously Treated Japanese Subjects With Nonresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation
- Conditions
- Interventions
- First Posted Date
- 2023-10-13
- Last Posted Date
- 2024-08-14
- Lead Sponsor
- Servier
- Target Recruit Count
- 12
- Registration Number
- NCT06081829
- Locations
- 🇯🇵
National Cancer Center Hospital East (JPN-002), Kashiwa, Japan
🇯🇵Kumamoto University Hospital (JPN-004), Kumamoto, Japan
🇯🇵National Hospital Organization Shikoku Cancer Center (JPN-007), Matsuyama, Japan
Ivosidenib, Nivolumab, and Ipilimumab Combination in Previously Treated Subjects With Nonresectable or Metastatic IDH1 Mutant Cholangiocarcinoma
- Conditions
- Interventions
- First Posted Date
- 2023-06-27
- Last Posted Date
- 2024-12-17
- Lead Sponsor
- Servier Bio-Innovation LLC
- Target Recruit Count
- 7
- Registration Number
- NCT05921760
- Locations
- 🇺🇸
UCSF - Medical Center at Mission Bay, San Francisco, California, United States
🇺🇸Ucsf Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
🇺🇸Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins, Baltimore, Maryland, United States
A Study of Gilteritinib in Combination with Ivosidenib or Enasidenib in People with Acute Myeloid Leukemia (AML)
- Conditions
- Interventions
- First Posted Date
- 2023-03-06
- Last Posted Date
- 2024-11-12
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 36
- Registration Number
- NCT05756777
- Locations
- 🇺🇸
Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States
🇺🇸Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States
🇺🇸Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States
Personalized Medicine for Advanced Biliary Cancer Patients
- First Posted Date
- 2022-11-14
- Last Posted Date
- 2024-11-26
- Lead Sponsor
- UNICANCER
- Target Recruit Count
- 800
- Registration Number
- NCT05615818
- Locations
- 🇧🇪
Universitair Ziekenhuis Leuven, Leuven, Belgium
🇫🇷CHU Amiens Picardie, Amiens, France
🇫🇷CHU d'Angers, Angers, France
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)
- Conditions
- Interventions
- First Posted Date
- 2022-06-02
- Last Posted Date
- 2024-03-04
- Lead Sponsor
- Alice Mims
- Target Recruit Count
- 125
- Registration Number
- NCT05401097
- Locations
- 🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Drug Development Updates
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