Clinical trials: IDH1 Mutation
Cholangiocarcinoma Non-resectable, Cholangiocarcinoma Metastatic
A Phase 2 Study of Ivosidenib in Previously Treated Japanese Subjects With Nonresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation
This study will enroll participants with nonresectable or metastatic cholangiocarcinoma with an Isocitrate dehydrogenase protein, 1 (IDH1) mutation, who have previously received at least 1, but no more than 2, prior regimens for…
- Trial name
- NCT06081829
- Testing
- Ivosidenib
- Where
- 7 sites in Japan
- Volunteers
- 12 people
- Sponsor
- Servier
Clonal Cytopenia of Undetermined Significance
Ivosidenib for Patients With Clonal Cytopenia of Undetermined Significance and Mutations in IDH1
This is an open-label, multicenter study exploring the efficacy of ivosidenib in patients with clonal cytopenia of undetermined significance (CCUS) with mutations in IDH1.
- Trial name
- NCT05030441
- Testing
- Ivosidenib
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Washington University School of Medicine
Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia
A Phase 2 Study Evaluating Olutasidenib in Patients With IDH1-mutated Clonal Cytopenia of Undetermined Significance and Lower-risk Myelodysplastic/Syndromes/Chronic Myelomonocytic Leukemia.
To learn if olutasidenib can help to control CCUS, MDS, and/or CMML. The safety of the drug will also be studied.
- Conditions
- Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, Clonal Cytopenia of Undetermined Significance
- Trial name
- NCT06566742
- Testing
- Olutasidenib
- Where
- 2 sites in United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- M.D. Anderson Cancer Center
IDH Mutation, IDH1 Mutation
A Study of Fedratinib With IDH Inhibition in Advanced-Phase, IDH-Mutated Ph-Negative Myeloproliferative Neoplasms
The purpose of this research is to gather information on the safety and effectiveness of fedratinib (a drug called a "jak inhibitor" ) in combination with ivosidenib or enasidenib (two anti-cancer drugs).
- Conditions
- IDH Mutation, IDH1 Mutation, IDH2 Gene Mutation, Blood Cancer
- Trial name
- NCT04955938
- Testing
- Ivosidenib, Enasidenib, Fedratinib
- Where
- United States
- Sponsor
- University of Chicago
Acute Myeloid Leukemia, Relapsed Adult AML
Ivosidenib Expanded Access Program in Relapsed/Refractory AML With an IDH1 Mutation
To provide access to ivosidenib monotherapy to patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase 1 (IDH1) mutation.
- Conditions
- Acute Myeloid Leukemia, Relapsed Adult AML, Relapsed Pediatric AML
- Trial name
- NCT03245424
- Testing
- ivosidenib (AG-120)
- Sponsor
- Agios Pharmaceuticals, Inc.
Acute Myeloid Leukemia
A Study to Evaluate HMPL-306 in Patients With IDH1or IDH2-mutated Acute Myeloid Leukemia
This study is a multicenter, randomized, open-label, phase III clinical study (RAPHAEL) to evaluate the efficacy, safety, and PK of HMPL-306 versus salvage chemotherapy in patients with R/R AML harboring IDH1 and IDH2 mutations.
- Trial name
- NCT06387069
- Testing
- HMPL-306 Regimen, Salvage Chemotherapy Regimen
- Where
- 53 sites in China
- Volunteers
- 316 people
- Sponsor
- Hutchmed
Myelodysplastic Syndromes, Acute Myeloid Leukemia
A Study of the IDH1 Inhibitor AG-120 in Combination With the Checkpoint Blockade Inhibitor, Nivolumab, for Patients With IDH1 Mutated Relapsed/Refractory AML and High Risk MDS
In this trial the investigators aim to evaluate safety and efficacy of combination Ivosidenib (AG-120) and nivolumab in the context of adult patients with Isocitrate dehydrogenase-1 (IDH1) mutated acute myeloid leukemias (AML) or…
- Trial name
- NCT04044209
- Testing
- AG-120, Nivolumab
- Where
- United States
- Sponsor
- Yale University
Cholangiocarcinoma With IDH1 Mutation, Solid Tumors With IDH1 Mutation
IDH1 Inhibitor AB-218 in Patients With Advanced IDH1 Mutant Cholangiocarcinoma and Other Solid Tumor
This is an open label, single-arm Phase I study to evaluate the safety, tolerability, PK and preliminary efficacy of AB-218, an oral IDH1 inhibitor, for the treatment of adult patients with advanced IDH1 mutant cholangiocarcinoma…
- Trial name
- NCT05814536
- Testing
- AB-218 capsule
- Where
- 14 sites in China
- Volunteers
- 9 people
- Sponsor
- AnHeart Therapeutics Inc.
Glioma
Phase I Trial of IDH1 Peptide Vaccine in IDH1R132H-mutated Grade III-IV Gliomas
The NOA-16 trial is the first-in-man trial of the IDH1 (isocitrate dehydrogenase type 1) peptide vaccine targeting the IDH1R132H mutation (amino acid exchange from arginine to glutamine at position 132 of IDH1).
- Trial name
- NOA-16 (NCT02454634)
- Testing
- IDH1 peptide vaccine
- Where
- 8 sites in Germany
- Volunteers
- 39 people
- Sponsor
- National Center for Tumor Diseases, Heidelberg
IDH1-mutant Cholangiocarcinoma
Ivosidenib, Nivolumab, and Ipilimumab Combination in Previously Treated Subjects With Nonresectable or Metastatic IDH1 Mutant Cholangiocarcinoma
This is a Phase 1/2 study evaluating the safety, tolerability, and activity of ivosidenib in combination with immunotherapy in participants with nonresectable or metastatic cholangiocarcinoma.
- Trial name
- NCT05921760
- Testing
- Ivosidenib, Nivolumab, Ipilimumab
- Where
- 5 sites in United States, United Kingdom
- Volunteers
- 7 people
- Sponsor
- Servier Bio-Innovation LLC
Biliary Tract Cancer
Role of ctDNA in Genetic Profiling & Outcomes for Advanced BTC
Biliary tract cancer (BTC) is a rare and heterogeneous disease with high incidence and mortality in Korea. Molecular profiling has enabled the identification of actionable alterations such as Isocitrate Dehydrogenase 1 (IDH1)…
- Trial name
- NCT07142226
- Testing
- Circulating Tumor DNA (ctDNA) Testing (ctDNA-based Next-Generation Sequencing (NGS))
- Where
- South Korea
- Volunteers
- 200 people
- Sponsor
- CHA University
Acute Myeloid Leukemia
Screening of IDH1 and IDH2 Gene Mutations in Adult Acute Myeloid Leukemia for Possible Targeted Therapy
1. To assess the incidence of IDH1 and IDH2 mutations in adult AML patients, and to explore their associations with the patients' clinical, cytogenetic, and molecular characteristics as well as with treatment response and…
- Trial name
- NCT03499912
- Where
- Taiwan
- Volunteers
- 300 people
- Sponsor
- National Taiwan University Hospital
Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome
Study of Orally Administered AG-881 in Patients With Advanced Hematologic Malignancies With an IDH1 and/or IDH2 Mutation
The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-881 in advanced hematologic malignancies that harbor an IDH1 and/or IDH2 mutation
- Conditions
- Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome, Hematologic Malignancies
- Trial name
- NCT02492737
- Testing
- AG881
- Where
- 6 sites in United States, France
- Volunteers
- 46 people
- Sponsor
- Agios Pharmaceuticals, Inc.
Chondrosarcomas, Cartilage Tumours
Diagnostic and Therapeutic Targets in Cartilaginous Tumours
This study, "Finding new diagnostic and therapeutic targets in cartilaginous tumours," focuses on improving the diagnosis, prognostic stratification, and treatment options for chondroid tumours, particularly chondrosarcoma.
- Trial name
- NCT07315542
- Testing
- Tumour tissue analysis, Molecular validation, Liquid biopsy analysis
- Where
- Czechia
- Volunteers
- 300 people
- Sponsor
- St. Anne's University Hospital Brno, Czech Republic
Recurrent IDH1/2 Mutated Glioma
Treatment With Azacitidine of Recurrent Gliomas With IDH1/2 Mutation
Glioma are the most commun frequent brain tumour. Mutation of Isocitrate DeHydrogenase IDH1 or IDH2 genes affect 40% of gliomas, mostly grade II and III gliomas.
- Trial name
- AGIR (NCT03666559)
- Testing
- Azacitidine
- Where
- France
- Volunteers
- 8 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Advanced Malignant Solid Neoplasm, Glioblastoma
Olaparib in Treating Patients With Advanced Glioma, Cholangiocarcinoma, or Solid Tumors With IDH1 or IDH2 Mutations
This phase II trial studies how well olaparib works in treating patients with glioma, cholangiocarcinoma, or solid tumors with IDH1 or IDH2 mutations that has spread from where it first started (primary site) to other places in…
- Conditions
- Advanced Malignant Solid Neoplasm, Glioblastoma, Recurrent Cholangiocarcinoma, Recurrent Glioma
- Trial name
- NCT03212274
- Testing
- Biopsy Procedure, Biospecimen Collection, Computed Tomography
- Where
- 51 sites in United States
- Volunteers
- 89 people
- Sponsor
- National Cancer Institute (NCI)
Glioma, Recurrence
Vorasidenib Expanded Access Program
This is an expanded access program to provide vorasidenib for treatment of patients 12 years or older with IDH1- or IDH2-mutated glioma.
- Conditions
- Glioma, Recurrence, Disease Attributes, Pathologic Processes
- Trial name
- NCT05592743
- Testing
- Vorasidenib
- Sponsor
- Servier
Advanced Solid Tumor, NSCLC (Non-small Cell Lung Cancer)
A Phase 1 Clinical Study of NXP900 in Subjects With Advanced Cancers
This is a multi-center, first-in-human, open label, dose escalation (Part A) and expansion (Part B) Phase 1 study in subjects with advanced solid tumors and in subjects with solid tumors with selected genetic alterations that are…
- Conditions
- Advanced Solid Tumor, NSCLC (Non-small Cell Lung Cancer), Renal Cancer, Mesothelioma
- Trial name
- NCT05873686
- Testing
- NXP900
- Where
- 15 sites in United States, United Kingdom
- Volunteers
- 140 people
- Sponsor
- Nuvectis Pharma, Inc.
AML, IDH1 Mutation
Venetoclax in Combination With Ivosidenib and Azacitidine for Newly Diagnosed IDH1-Mutated AML
Venetoclax can bind to the BCL-2 protein, thereby initiating the apoptosis program and exerting anti-AML effects. The induction regimen combining venetoclax with hypomethylating agents (HMA) significantly improves the remission…
- Conditions
- AML, IDH1 Mutation, Treatment
- Trial name
- IDH1-AML-2024 (NCT06611839)
- Testing
- Ivosidenib, Venetoclax, Azacitidine
- Where
- China
- Volunteers
- 23 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation
Vorasidenib Study in Pediatric Participants With Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation
The objective of this study is to evaluate the safety, tolerability, efficacy profile, and effect on growth and development of vorasidenib in pediatric participants aged 12 to < 18 years old with grade 2 glioma with an IDH1 or…
- Trial name
- NCT07286292
- Testing
- Vorasidenib
- Where
- 5 sites in United States, Australia
- Volunteers
- 10 people
- Sponsor
- Institut de Recherches Internationales Servier (I.R.I.S.)