Clinical trials: Isocitrate Dehydrogenase Gene Mutation
Grade 2 Glioma (Astrocytoma or Oligodendroglioma) With an IDH1 Mutation, Astrocytoma IDH Mutant Grade 2
Safety and Efficacy Study of Safusidenib in Participants With Grade 2 IDH1-Mutant Glioma
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study comparing the efficacy and safety of safusidenib versus placebo in participants with residual or recurrent Grade 2 glioma (oligodendroglioma or…
- Conditions
- Grade 2 Glioma (Astrocytoma or Oligodendroglioma) With an IDH1 Mutation, Astrocytoma IDH Mutant Grade 2, Oligodendroglioma, Oligodendroglioma IDH-mutant and 1p/19q-codeleted
- Trial name
- NCT07712757
- Testing
- Safusidenib
- Volunteers
- 140 people
- Sponsor
- Nuvation Bio Inc.
Biliary Carcinoma
A Clinical Study of TQB3454 Tablets in the Treatment of Advanced Biliary Carcinoma.
This study used a randomized, controlled, double-blind, multicenter Phase III clinical design with overall survival (OS) as the primary endpoint.
- Trial name
- NCT05987358
- Testing
- TQB3454 tablets
- Where
- 6 sites in China
- Volunteers
- 165 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Brain Tumor, Cancer
000860: A Phase I/II Study of Zotiraciclib for Recurrent Malignant Gliomas With Isocitrate Dehydrogenase 1 or 2 (IDH1 or IDH2) Mutations
Protocol # 000860 Background: Diffuse gliomas are tumors that affect the brain and spinal cord. Gliomas that develop in people with certain gene mutations (IDH1 or IDH2) are especially aggressive. Better treatments are needed.
- Trial name
- NCT05588141
- Testing
- Zotiraciclib
- Where
- United States
- Volunteers
- 96 people
- Sponsor
- National Cancer Institute (NCI)
Hematologic Neoplasms
Phase 1/2 Study of Enasidenib (AG-221) in Adults With Advanced Hematologic Malignancies With an Isocitrate Dehydrogenase Isoform 2 (IDH2) Mutation
The primary objectives of Phase 1 Dose Escalation/Part 1 Expansion are: To assess the safety and tolerability of treatment with enasidenib administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle…
- Trial name
- NCT01915498
- Testing
- Enasidenib
- Where
- 24 sites in United States, France
- Volunteers
- 345 people
- Sponsor
- Celgene
Glioma, Cholangiocarcinoma
Metformin And Chloroquine in IDH1/2-mutated Solid Tumors
This phase Ib, open-label, single-center, non-randomized clinical trial will evaluate the toxicity and efficacy of metformin and chloroquine in isocitrate dehydrogenase 1/2-mutated (IDH1/2MT) patients with a glioma, intrahepatic…
- Conditions
- Glioma, Cholangiocarcinoma, Chondrosarcoma
- Trial name
- MACIST (NCT02496741)
- Testing
- Metformin and chloroquine combination
- Where
- 3 sites in Netherlands
- Volunteers
- 15 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Solid Tumors, Triple-Negative Breast Cancer
Study of the Glutaminase Inhibitor CB-839 in Solid Tumors
Many tumor cells, in contrast to normal cells, have been shown to require the amino acid glutamine to produce energy for growth and survival.
- Conditions
- Solid Tumors, Triple-Negative Breast Cancer, Non Small Cell Lung Cancer, Renal Cell Carcinoma
- Trial name
- NCT02071862
- Testing
- CB-839, Pac-CB, CBE
- Where
- 13 sites in United States
- Volunteers
- 210 people
- Sponsor
- Calithera Biosciences, Inc
Isocitrate Dehydrogenase Gene Mutation
A Study of HMPL-306 in Advanced Hematological Malignancies With mIDH
An open label single-arm clinical trial to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of HMPL-306 in subjects with advanced relapsed, refractory, or resistant hematological malignancies that harbor IDH…
- Trial name
- NCT04764474
- Testing
- HMPL-306
- Where
- 15 sites in United States, Spain
- Volunteers
- 46 people
- Sponsor
- Hutchmed
AML, MDS
Prospective Evaluation of Ivosidenib Maintenance Following Allogeneic Stem Cell Transplantation in Patients With Acute Myeloid Leukemia or High-risk Myelodysplastic Neoplasia With IDH1 (Isocitrate Dehydrogenase 1) Mutation
maintenance of AML or MDS patients with known IDH1 mutation after allogeneic stem cell transplantation within past 100 days
- Trial name
- PIVOT (NCT06717958)
- Testing
- Ivosidenib 250 MG (milligram)
- Where
- 17 sites in Germany
- Volunteers
- 76 people
- Sponsor
- Technische Universität Dresden
Glioma
Trial of IDH305 in IDH1 Mutant Grade II or III Glioma
The purpose of this study is to found out if the drug IDH305 is safe and effective in subjects with IDH1 mutant grade II or III glioma that has progressed after observation or radiation therapy.
- Trial name
- NCT02977689
- Testing
- IDH305
- Where
- United States
- Sponsor
- NYU Langone Health
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
NSCLC Patients With EGFR Activating Mutation, Adenoid Cystic Carcinoma Metastatic
First in Human Multicenter Open Name Dose-increase, Consolidation Method to Study Safety Drug-level in Blood & Drug Metabolism Clinical Activity of Oral JBI-778 in Lung Cancer Patients With, Without Brain Metastasis IDH Mutated WHO Grade 3,4 Recurrent Glioma, Salivary Glands Tumor
This is a phase 1, multicentre, first-in-human, open-label, dose-escalation/consolidation study to investigate the safety, pharmacokinetics, pharmacodynamics, and clinical activity of orally administered JBI-778 in EGFR mutated…
- Conditions
- NSCLC Patients With EGFR Activating Mutation, Adenoid Cystic Carcinoma Metastatic, Adenoid Cystic Carcinoma of the Head and Neck
- Trial name
- NCT07755397
- Testing
- JBI-778
- Where
- 6 sites in India
- Volunteers
- 30 people
- Sponsor
- Jubilant Therapeutics India Limited
Glioblastoma, IDH1 Gene Mutation
BGB-290 and Temozolomide in Treating Isocitrate Dehydrogenase (IDH)1/2-Mutant Grade I-IV Gliomas
This phase I trial studies the side effects and best dose of BGB-290 and temozolomide in treating adolescents and young adults with IDH1/2-mutant grade I-IV glioma that is newly diagnosed or has come back.
- Conditions
- Glioblastoma, IDH1 Gene Mutation, IDH2 Gene Mutation, Low Grade Glioma
- Trial name
- PNOC017 (NCT03749187)
- Testing
- PARP Inhibitor BGB-290, Temozolomide (TMZ)
- Where
- 11 sites in United States
- Volunteers
- 78 people
- Sponsor
- University of California, San Francisco
Astrocytoma, IDH-Mutant, Grade 3, Astrocytoma, IDH-Mutant, Grade 4
IDH1-vac in Patients With Newly Diagnosed IDH1R132H-positive High-grade Astrocytomas
STAR-VACC is a randomized double-blind controlled Phase 2 study assessing clinical efficacy of IDH1-vac in patients with newly diagnosed IDH1-mutant high-grade astrocytomas.
- Trial name
- STAR-VACC (NCT07888647)
- Testing
- IDH1-vac, IS-vac, Temozolomide (TMZ)
- Where
- 13 sites in Germany
- Volunteers
- 216 people
- Sponsor
- German Cancer Research Center
Adult Gliomas, Mixed
Hyperpolarized Carbon-13 Alpha-ketoglutarate Imaging in IDH Mutant Glioma
This study will investigate the use of hyperpolarized (HP) carbon-13 (13C) alpha-ketoglutarate (aKG) (HP 13C-aKG) to characterize tumor burden in participants with isocitrate dehydrogenase (IDH) mutant glioma.
- Trial name
- NCT05851378
- Testing
- Hyperpolarized Carbon 13 Alpha-ketoglutarate (HP C13-aKG), Magnetic Resonance Image (MRI)
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Robert Bok, MD, PhD
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Using the Anticancer Drug Olaparib to Treat Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome With an Isocitrate Dehydrogenase (IDH) Mutation
This phase II trial studies how well olaparib works in treating patients with acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory), or myelodysplastic syndrome.
- Conditions
- Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Acute Myeloid Leukemia Post Cytotoxic Therapy, Recurrent Acute Myeloid Leukemia
- Trial name
- NCT03953898
- Testing
- Biospecimen Collection, Bone Marrow Aspiration, Olaparib
- Where
- 11 sites in United States
- Volunteers
- 14 people
- Sponsor
- National Cancer Institute (NCI)
Leukemia, Myeloid, Isocitrate Dehydrogenase
An Efficacy and Safety Study of AG-221 (CC-90007) Versus Conventional Care Regimens in Older Subjects With Late Stage Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation
This is an international, multicenter, open-label, randomized, Phase 3 study comparing the efficacy and safety of AG-221 versus conventional care regimens (CCRs) in subjects 60 years or older with acute myeloid leukemia (AML)…
- Trial name
- IDHENTIFY (NCT02577406)
- Testing
- AG-221, BSC, Azacitidine
- Where
- 93 sites in United States, Australia and 16 more
- Volunteers
- 319 people
- Sponsor
- Celgene
Isocitrate Dehydrogenase Gene Mutation
A Study of HMPL-306 in Advanced Solid Tumors With IDH Mutations
An open label single-arm clinical trial to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of HMPL-306 in advanced or metastatic solid tumors with IDH mutation.
- Trial name
- NCT04762602
- Testing
- HMPL-306
- Where
- 11 sites in United States, Spain
- Volunteers
- 42 people
- Sponsor
- Hutchmed