Clinical trials: IDH1 Mutation
Targeted Therapy, IDH1-Mutated Malignancies
Olutasidenib Combined With Co-targeted Therapy in Relapsed or Refractory IDH1-mutated Myeloid Malignancies Harboring Activated Signaling Pathway Mutations
To learn about the safety and tolerability of study drug combinations in patients with relapsed/refractory, IDH1-mutated myeloid malignancies with a co-signaling mutation.
- Conditions
- Targeted Therapy, IDH1-Mutated Malignancies, Mutations
- Trial name
- NCT07032727
- Testing
- Olutasidenib, Cladribine (CLAD), Venetoclax
- Where
- 2 sites in United States
- Volunteers
- 68 people
- Sponsor
- M.D. Anderson Cancer Center
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
Myeloid Malignancies
A Phase II Open-label Study of Olutasidenib Post-transplant Maintenance Therapy for Patients With IDH1-mutated Myeloid Malignancies
The goal of this clinical research study is to learn about the safety and tolerability of giving olutasidenib to patients with IDH1-mutated myeloid malignancies as maintenance therapy after they receive a stem cell transplant.
- Trial name
- NCT06668584
- Testing
- Olutasidenib
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- M.D. Anderson Cancer Center
Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia
Olutasidenib for the Treatment of Patients With IDH1 Mutated AML, MDS or CMML After Donor Hematopoietic Cell Transplant
This phase I trial tests the safety, side effects, and effectiveness of olutasidenib in preventing the return of disease (relapse) in patients who have undergone donor (allogeneic) hematopoietic cell transplant for acute myeloid…
- Conditions
- Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome
- Trial name
- NCT06543381
- Testing
- Biospecimen Collection, Olutasidenib
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- City of Hope Medical Center
AML, Adult
Italian Registry on the Prevalence of IDH1/IDH2 Mutations in Patients With Acute Myeloid Leukemia
This is a study where there are no interventions planned. Investigators will only collect data already in the patient's history and analyze it. Particularly, we are interested in molecular data from AML patients.
- Trial name
- NCT02986620
- Testing
- IDH mutation test performed at diagnosis or relapse until January 31st, 2019.
- Where
- 24 sites in Italy
- Volunteers
- 388 people
- Sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
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
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)
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.
IDH1 Mutation, Relapsed / Refractory AML
Olutasidenib in Relapsed IDH1 Mutated AML Patients Who Have Previously Received Venetoclax
This is a prospective, single-arm phase 2 pilot study to assess the response rate of IDH1 mutated relapsed/refractory acute myeloid leukemia (AML) patients who receive olutasidenib after progressing on venetoclax based regimens.
- Trial name
- NCT07471841
- Testing
- Olutasidenib, Azacitidine (AZA)
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Timothy Pardee
Recurrent High-grade Glioma
A Study to Evaluate the Safety and Effectiveness of PCV Chemotherapy in Patients With Recurrent High-grade Glioma With IDH1/2 Mutation
This trial is aimed at evaluating the safety and effectiveness of PCV chemotherapy in patients with recurrent high-grade glioma with IDH1/2 mutation.
- Trial name
- NCT02333513
- Testing
- Lomustine/Vincristine/Procarbazine
- Where
- 2 sites in China
- Volunteers
- 100 people
- Sponsor
- Hebei Yanda Hospital
Low Grade Glioma, WHO Grade 3 Glioma With IDH1 Mutation
Proton Radiation Therapy for Gliomas
In this research study the investigators are looking at a type of radiation called proton radiation. Proton radiation has been shown to deliver virtually no radiation beyond the area of the tumor, sparing surrounding normal…
- Conditions
- Low Grade Glioma, WHO Grade 3 Glioma With IDH1 Mutation, WHO Grade 3 Glioma With 1p/19q Codeletion
- Trial name
- NCT01358058
- Testing
- Proton radiation
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- Massachusetts General Hospital
Acute Myeloid Leukemia, NPM1 Mutation
Study on the Efficacy and Safety of VA Regimen Compared to "3+7" Regimen in Newly Diagnosed AML With NPM1 or IDH1/IDH2 Mutations
This prospective, multicenter, randomized, open-label, non-inferiority clinical study aims to compare the efficacy and safety of VA regimen (venetoclax combined with azacitidine) versus conventional "3+7" chemotherapy regimen in…
- Conditions
- Acute Myeloid Leukemia, NPM1 Mutation, IDH1 Mutation, IDH2 Mutation
- Trial name
- NCT07664839
- Testing
- VEN combined with azacitidine, Cytarabine plus Daunorubicin
- Where
- China
- Volunteers
- 148 people
- Sponsor
- Shen yang
IDH1-mutant Glioma, IDH2-mutant Glioma
Vorasidenib in Combination With Temozolomide (TMZ) in IDH-mutant Glioma
The objective of this study is to determine the safety and tolerability of vorasidenib in combination with temozolomide (TMZ) and to establish the recommended combination dose (RCD) of vorasidenib.
- Trial name
- NCT06478212
- Testing
- Vorasidenib, Temozolomide (TMZ)
- Where
- 28 sites in United States, Austria and 9 more
- Volunteers
- 51 people
- Sponsor
- Institut de Recherches Internationales Servier
Colorectal Cancer, Triple Negative Breast Cancer
A Study of Toca 511, a Retroviral Replicating Vector, Combined With Toca FC in Patients With Solid Tumors or Lymphoma (Toca 6)
The purpose of this trial is to evaluate changes in immune activity relative to baseline following treatment with Toca 511 and Toca FC in patients with solid tumors (including recurrent high grade glioma [rHGG]) or lymphoma.
- Conditions
- Colorectal Cancer, Triple Negative Breast Cancer, Pancreatic Cancer, Non-Small Cell Lung Cancer
- Trial name
- NCT02576665
- Testing
- Toca 511, Toca FC
- Where
- 3 sites in United States
- Volunteers
- 21 people
- Sponsor
- Tocagen Inc.
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
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.
Grade 2 Glioma, Residual Glioma
Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)
Study AG881-C-004 is a phase 3, multicenter, randomized, double-blind, placebo-controlled study comparing the efficacy of vorasidenib to placebo in participants with residual or recurrent Grade 2 glioma with an IDH1 or IDH2…
- Conditions
- Grade 2 Glioma, Residual Glioma, Recurrent Glioma
- Trial name
- NCT04164901
- Testing
- Vorasidenib
- Where
- 84 sites in United States, Canada and 9 more
- Volunteers
- 331 people
- Sponsor
- Institut de Recherches Internationales Servier
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
Recurrent Ependymoma, Recurrent Ewing Sarcoma
Ivosidenib in Treating Patients With Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With IDH1 Mutations (A Pediatric MATCH Treatment Trial)
This phase II Pediatric MATCH trial studies how well ivosidenib works in treating patients with solid tumors, including central nervous system tumors, lymphomas and histiocytic disorders that have not responded to (refractory) or…
- Conditions
- Recurrent Ependymoma, Recurrent Ewing Sarcoma, Recurrent Hepatoblastoma, Recurrent Langerhans Cell Histiocytosis
- Trial name
- NCT04195555
- Testing
- Ivosidenib
- Where
- 174 sites in United States, Australia and 1 more
- Volunteers
- 3 people
- Sponsor
- National Cancer Institute (NCI)
Acute Myeloid Leukemia
Study Evaluating the Efficacy and Safety of the Addition of Ivosidenib to Oral Azacitidine (Onureg®) in Patients Over 55 With Acute Myeloid Leukemia (AML) and IDH1 Mutation, in Complete Remission After Intensive Chemotherapy.
After remission post-induction and consolidation, maintenance therapy by an ivosidenib and oral azacitidine combination is susceptible to improve the prevention of AML relapse, which remains a major issue in the study population.
- Trial name
- MIVONU (NCT07463768)
- Testing
- Ivosidenib + oral azacitidine
- Where
- 20 sites in France
- Volunteers
- 60 people
- Sponsor
- French Innovative Leukemia Organisation