Clinical trials: IDH1 Mutation
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.
Recurrent Glioma, IDH-mutant Gliomas
VorAsidenib With Lomustine In Patients With rEcurrent IDH-mutaNT Glioma Harboring IDH1 and/or IDH2 Mutations
This phase I study will evaluate the safety and tolerability of vorasidenib in combination with lomustine and determine the recommended combination dose (RCD) of vorasidenib in adults with recurrent IDH1- or IDH2-mutant glioma.
- Trial name
- VALIENT (NCT07629089)
- Testing
- Vorasidenib, Lomustine
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Megan Mantica
AML (Acute Myeloid Leukemia), MDS (Myelodysplastic Syndrome)
Ivosidenib as Maintenance Therapy in Transplant-Ineligible IDH1-mutated AML and HR-MDS
This study will explore the efficacy and safety of ivosidenib as maintenance therapy in patients with IDH1-mutated AML and high-risk MDS who are ineligible for transplantation, along with accompanying molecular biomarker…
- Trial name
- NCT07607418
- Testing
- Ivosidenib
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Ruijin Hospital
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
Acute Myeloid Leukemia With Gene Mutations, Myelodysplastic Syndrome
CPX-351 and Ivosidenib for the Treatment of IDH1 Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
This phase II trial investigates how well CPX-351 and ivosidenib work in treating patients with acute myeloid leukemia or high-risk myelodysplastic syndrome that has IDH1 mutation.
- Conditions
- Acute Myeloid Leukemia With Gene Mutations, Myelodysplastic Syndrome, Myeloproliferative Neoplasm, Recurrent Acute Myeloid Leukemia
- Trial name
- NCT04493164
- Testing
- Ivosidenib, Liposome-encapsulated Daunorubicin-Cytarabine
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- M.D. Anderson Cancer Center
Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS), Myelodysplastic Syndromes (MDS)
Ivosidenib (IVO) Monotherapy and Azacitidine (AZA) Monotherapy in Patients With Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) With an IDH1 Mutation
This study will enroll participants with myelodysplastic syndromes (MDS) with an Isocitrate dehydrogenase protein, 1 (IDH1) mutation, who have not received treatment with a hypomethylating agent previously.
- Trial name
- PyramIDH (NCT06465953)
- Testing
- Ivosidenib, Azacitidine
- Where
- 62 sites in United States, Australia and 8 more
- Volunteers
- 48 people
- Sponsor
- Institut de Recherches Internationales Servier
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
Biliary Tract Cancer
An Exploratory Study on the Use of Ivosidenib for the Precise Treatment of Advanced Biliary Tract Malignancies With IDH1 Mutations in the Later Line of Therapy.
This is a multicenter, non-randomized, umbrella, open-label phase II clinical study, aiming to observe and evaluate, as well as explore the efficacy and safety of precision targeted therapy based on NGS technology for…
- Trial name
- NCT07282262
- Testing
- Ivosidenib, Lenvatinib, PD-1/PD-L1 inhibitor
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Peking Union Medical College Hospital
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