Clinical trials: IDH1 Mutation
WHO Grade II Glioma
A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma
This Phase 2 study is conducted to assess the efficacy and safety of DS-1001b in patients with chemotherapy- and radiotherapy-naive IDH1 mutated WHO grade II glioma.
- Trial name
- NCT04458272
- Testing
- DS-1001b
- Where
- 11 sites in Japan
- Volunteers
- 25 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Cholangiocarcinoma
Ivosidenib in Locally Advanced or Metastatic Cholangiocarcinoma With IDH1 R132 Mutation After at Least One Prior Systemic Treatment - an Observational Study
Cholangiocarcinoma is a rare and aggressive tumor of the bile duct associated with a poor prognosis and very limited treatment options. The IDH1 inhibitor ivosidenib provides a new, targeted treatment option for this disease.
- Trial name
- IDHIRA (NCT06607302)
- Where
- 19 sites in Germany
- Volunteers
- 100 people
- Sponsor
- iOMEDICO AG
Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)
Study of Oral LY3410738 in Patients With Advanced Hematologic Malignancies With IDH1 or IDH2 Mutations
This is an open-label, multi-center Phase 1 study of LY3410738, an oral, covalent isocitrate dehydrogenase (IDH) inhibitor, in patients with IDH1 and/or IDH2-mutant advanced hematologic malignancies who may have received standard…
- Conditions
- Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), Chronic Myelomonocytic Leukemia (CMML), Myeloproliferative Neoplasms (MPNs)
- Trial name
- NCT04603001
- Testing
- LY3410738, Venetoclax, Azacitidine
- Where
- 37 sites in United States, Australia and 10 more
- Volunteers
- 260 people
- Sponsor
- Eli Lilly and Company
Acute Myeloid Leukemia (AML)
An Open-label Phase 3b Study of Ivosidenib in Combination With Azacitidine in Adult Patients Newly Diagnosed With IDH1m Acute Myeloid Leukemia (AML) Ineligible for Intensive Induction Chemotherapy.
The purpose of this study is to learn more about the safety and efficacy of ivosidenib taken with azacitidine to treat adult patients with acute myeloid leukemia (AML) who are presenting a gene mutation called IDH1 (isocitrate…
- Trial name
- NCT05907057
- Testing
- Ivosidenib 500mg Oral Tablet, Azacitidine
- Where
- 15 sites in Austria, France and 2 more
- Volunteers
- 245 people
- Sponsor
- Servier Affaires Médicales
AML (Acute Myeloid Leukemia), Glioma
Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignancies
A open-label drug-drug interaction (DDI) study to evaluate the effects of olutasidenib on the pharmacokinetics (PK) of a CYP450 and OATP1B1 probe substrate cocktail in participants with IDH1 mutation-positive malignancies.
- Conditions
- AML (Acute Myeloid Leukemia), Glioma, Cholangiocarcinoma, Solid Tumor Malignancies
- Trial name
- NCT07486713
- Testing
- Olutasidenib, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Probe Substrates
- Where
- 2 sites in United States
- Volunteers
- 16 people
- Sponsor
- Rigel Pharmaceuticals
Acute Myeloid Leukemia (AML)
Ivosidenib (TIBSOVO®) Combined With Azacitidine According to Current SmPC
The goal of this non-interventional study is to evaluate quality of life (QoL) in adult patients with newly diagnosed IDH1 R132-mutated AML who are not eligible to receive standard induction chemotherapy and who are treated with…
- Trial name
- CONFIDHENCE (NCT06181734)
- Testing
- Ivosidenib
- Where
- Germany
- Volunteers
- 8 people
- Sponsor
- iOMEDICO AG
Cholangiocarcinoma, Chondrosarcoma
Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 or IDH2 Mutations
This is an open-label, multicenter Phase 1 study to evaluate safety, tolerability and preliminary efficacy of oral LY3410738 in patients with isocitrate dehydrogenase 1 (IDH1) arginine 132 (R132)-mutant advanced solid tumors…
- Conditions
- Cholangiocarcinoma, Chondrosarcoma, Glioma, Any Solid Tumor
- Trial name
- NCT04521686
- Testing
- LY3410738, Gemcitabine, Cisplatin
- Where
- 33 sites in United States, Australia and 7 more
- Volunteers
- 200 people
- Sponsor
- Eli Lilly and Company
Glioma
Study of DS-1001b in Patients With Gene IDH1-Mutated Gliomas
This is a study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of DS-1001b in patients with gliomas that harbor IDH1-R132 mutations.
- Trial name
- NCT03030066
- Testing
- DS-1001b
- Where
- Japan
- Volunteers
- 47 people
- Sponsor
- Daiichi Sankyo
Acute Myeloid Leukemia
A Study of HMPL-306 in Patients With IDH1 and/or IDH2 Mutation of Relapsed/Refractory Myeloid Leukemia/Neoplasms
Phase I, multicenter study to evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy of HMPL-306 in Patients of Relapsed/Refractory Myeloid Leukemia/Neoplasms with IDH1 and/or IDH2 Mutation.
- Trial name
- NCT04272957
- Testing
- HMPL-306
- Where
- China
- Volunteers
- 75 people
- Sponsor
- Hutchison Medipharma Limited
Relapsed or Refractory Acute Myeloid Leukemia
A China Bridging Study of Ivosidenib in r/r AML Subjects With an IDH1 Mutation
This is a phase 1, multi-center, single-arm study to evaluate the pharmacokinetics(PK)/ pharmacodynamics(PD), safety, and clinical efficacy of orally administered Ivosidenib in Chinese subjects with R/R AML with an IDH1 mutation.
- Trial name
- NCT04176393
- Testing
- ivosidenib
- Where
- China
- Volunteers
- 30 people
- Sponsor
- CStone Pharmaceuticals
Gliomas Harboring IDH1 and/or IDH2 Mutations
Phase I Study of HMPL-306 for the Treatment of Gliomas With IDH1 and/or IDH2 Mutations
This study is a multicenter, randomized controlled Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of HMPL-306 in patients with gliomas harboring IDH1…
- Trial name
- NCT07025018
- Testing
- HMPL-306
- Where
- China
- Volunteers
- 52 people
- Sponsor
- Hutchmed
Leukemia, Myeloid, Acute
A Study to Assess the Safety and Efficacy of Two Combinations of Isocitrate Dehydrogenase (IDH) Mutant Targeted Therapies Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) Harboring IDH Mutations Who Are Not Candidates to Receive Intensive Induction Chemotherapy
The purpose of this study are 1. to determine the recommended combination dose of AG-120 and AG-221 separately when administered with azacitidine and, 2.
- Trial name
- NCT02677922
- Testing
- AG-120, Azacitidine, AG-221
- Where
- 49 sites in United States, Australia and 12 more
- Volunteers
- 130 people
- Sponsor
- Celgene
Acute Myeloid Leukemia, Acute Myelogenous Leukemia
Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation
This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 (olutasidenib) as a single agent or in combination with azacitidine or cytarabine.
- Conditions
- Acute Myeloid Leukemia, Acute Myelogenous Leukemia, Myelodysplastic Syndrome
- Trial name
- NCT02719574
- Testing
- FT-2102 (olutasidenib), Azacitidine, Cytarabine
- Where
- 60 sites in United States, Australia and 7 more
- Volunteers
- 336 people
- Sponsor
- Forma Therapeutics, Inc.
Cohort 1a and 1b: Glioma (Advanced Gliomas and Glioblastoma Multiforme), Cohort 2a and 2b: Hepatobiliary Tumors (Hepatocellular Carcinoma, Bile Duct Carcinoma, Intrahepatic Cholangiocarcinoma, Other Hepatobiliary Carcinomas)
A Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation
This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 as a single agent and in combination with other anti-cancer drugs in patients with advanced solid tumors and gliomas.
- Conditions
- Cohort 1a and 1b: Glioma (Advanced Gliomas and Glioblastoma Multiforme), Cohort 2a and 2b: Hepatobiliary Tumors (Hepatocellular Carcinoma, Bile Duct Carcinoma, Intrahepatic Cholangiocarcinoma, Other Hepatobiliary Carcinomas), Cohort 3a and 3b: Chondrosarcoma, Cohort 4a and 4b: Intrahepatic Cholangiocarcinoma
- Trial name
- NCT03684811
- Testing
- FT-2102, Azacitidine, Nivolumab
- Where
- 26 sites in United States, Australia and 4 more
- Volunteers
- 93 people
- Sponsor
- Forma Therapeutics, Inc.
Leukemia, Myeloid, Acute
BAY1436032 in Patients With Mutant IDH1(mIDH1) Advanced Acute Myeloid Leukemia (AML)
To determine the maximum tolerated and / or recommended Phase II dose of oral mutant IDH1 (mIDH1) inhibitor BAY1436032 and to characterize its safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical…
- Trial name
- NCT03127735
- Testing
- BAY1436032
- Where
- 13 sites in United States, Germany
- Volunteers
- 27 people
- Sponsor
- Bayer