Idasanutlin

DRUG14 trials

Sponsors

Hoffmann-La Roche, Mayo Clinic, University Hospital Heidelberg, Vanderbilt-Ingram Cancer Center, St. Jude Children's Research Hospital

Conditions

Acute Lymphoblastic Leukemia (ALL)Acute Myeloid LeukemiaAcute Myeloid Leukemia (AML)Atypical Teratoid/Rhabdoid TumorAtypical Teratoid/Rhabdoid Tumor of CNSCNS TumorColorectal CancerEstrogen Receptor-positive

Phase 1

A Study of Idasanutlin in Combination With Obinutuzumab in Relapsed/Refractory (R/R) Follicular Lymphoma (FL) and in Combination With Rituximab in R/R Diffuse Large B-Cell Lymphoma (DLBCL) Participants

TerminatedNCT02624986

Hoffmann-La RocheNon-Hodgkin's Lymphoma

Start: 2015-12-23End: 2019-05-20Updated: 2020-05-18

Idasanutlin, Ixazomib Citrate, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma

CompletedNCT02633059

Mayo ClinicLoss of Chromosome 17p, Recurrent Plasma Cell Myeloma

Start: 2015-12-30End: 2022-11-01Updated: 2024-09-19

A Study of Venetoclax in Combination With Cobimetinib and Venetoclax in Combination With Idasanutlin in Patients With Relapsed or Refractory Acute Myeloid Leukemia Who Are Not Eligible for Cytotoxic Therapy

CompletedNCT02670044

Hoffmann-La RocheLeukemia, Myeloid, Acute

Start: 2016-03-09End: 2020-12-10Updated: 2022-01-03

A Study to Determine the Excretion Balance, Pharmacokinetics, Metabolism and Absolute Oral Bioavailability of a Single Oral Dose of [14C]-Labeled Idasanutlin and an Intravenous Tracer Dose of [13C]-Labeled Idasanutlin in a Single Cohort of Participants With Solid Tumors (Malignancies)

CompletedNCT02828930

Hoffmann-La RocheSolid Tumors

Start: 2016-09-08End: 2017-06-19Updated: 2017-12-18

A Study of Obinutuzumab in Combination With Idasanutlin and Venetoclax in Participants With Relapsed or Refractory (R/R) Follicular Lymphoma (FL) or Rituximab in Combination With Idasanutlin and Venetoclax in Participants With R/R Diffuse Large B-Cell Lymphoma (DLBCL)

TerminatedNCT03135262

Hoffmann-La RocheFollicular Lymphoma, Lymphoma, Large B-Cell, Diffuse

Start: 2017-06-15End: 2020-04-30Updated: 2021-12-07

NCT Neuro Master Match - N²M² (NOA-20)

CompletedNCT03158389

University Hospital HeidelbergGlioblastoma, Adult

Start: 2018-05-07End: 2023-02-22Updated: 2023-09-28

A Study to Investigate the Bioequivalence or Relative Bioavailability of Three New Idasanutlin Tablet Variants Following Oral Administration in Participants With Solid Tumors

CompletedNCT03362723

Hoffmann-La RocheSolid Tumors

Start: 2017-11-27End: 2019-06-11Updated: 2019-06-19

A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Colorectal Cancer (Morpheus-CRC)

TerminatedNCT03555149

Hoffmann-La RocheColorectal Cancer

Start: 2018-09-27End: 2022-09-26Updated: 2023-11-07

Atezolizumab and Cobimetinib or Idasanutlin in Participants With Stage IV or Unresectable Recurrent Estrogen Receptor Positive Breast Cancer

TerminatedNCT03566485

Vanderbilt-Ingram Cancer CenterEstrogen Receptor-positive, HER2/Neu Negative, Stage IIIA Breast Cancer +4

Start: 2018-07-10End: 2020-12-10Updated: 2021-08-11

A Study Evaluating the Safety and Efficacy of Idasanutlin in Combination With Cytarabine and Daunorubicin in Patients Newly Diagnosed With Acute Myeloid Leukemia (AML) and the Safety and Efficacy of Idasanutlin in the Maintenance of First AML Complete Remission

TerminatedNCT03850535

Hoffmann-La RocheAcute Myeloid Leukemia

Start: 2019-03-25End: 2020-09-10Updated: 2022-06-21

A Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Activity of Idasanutlin in Combination With Either Chemotherapy or Venetoclax in Treatment of Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias or Solid Tumors

TerminatedNCT04029688

Hoffmann-La RocheAcute Lymphoblastic Leukemia (ALL), Acute Myeloid Leukemia (AML), Neuroblastoma +1

Start: 2020-01-27End: 2024-05-06Updated: 2024-12-20

Trial of Idasanutlin and Selinexor Therapy for Children With Progressive/Relapsed AT/RT or Extra-CNS Malignant Rhabdoid Tumors

WithdrawnNCT05952687

St. Jude Children's Research HospitalAtypical Teratoid/Rhabdoid Tumor, Atypical Teratoid/Rhabdoid Tumor of CNS, CNS Tumor +1

Start: 2024-03-31End: 2032-08-31Updated: 2024-03-27

Phase 2

A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Idasanutlin Monotherapy in Participants With Hydroxyurea-Resistant/Intolerant Polycythemia Vera

TerminatedNCT03287245

Hoffmann-La RochePolycythemia Vera

Start: 2018-02-21End: 2020-03-03Updated: 2021-12-08

Phase 3

A Study of Idasanutlin With Cytarabine Versus Cytarabine Plus Placebo in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)

TerminatedNCT02545283

Hoffmann-La RocheLeukemia, Myeloid, Acute

Start: 2015-12-30End: 2020-04-24Updated: 2022-01-11

Related Papers

Idasanutlin in Combination with Chemotherapy or Venetoclax in Pediatric and Young Adult Patients with Relapsed/Refractory Solid Tumors (iMATRIX Idasa): Results of a Phase I/II, Multicenter, Multi-arm Study.

2025-12-11

Molecularly matched targeted therapies plus radiotherapy in glioblastoma: the phase 1/2a N2M2 umbrella trial

Nature Medicine2025-09-054 citations

Abstract CT169: Phase Ib/II open-label, randomized study of atezolizumab + regorafenib + AB928 or atezolizumab + regorafenib vs regorafenib for patients with microsatellite-stable, refractory metastatic colorectal cancer in MORPHEUS-CRC

Cancer Research2025-04-25

N2M2/NOA-20: Phase I/IIa umbrella trial of molecularly matched targeted therapies plus radiotherapy in patients with newly diagnosed glioblastoma without <i>MGMT</i> promoter hypermethylation.

Journal of Clinical Oncology2024-06-011 citations

Durable Clinical Benefits of Idasanutlin Therapy in Hydroxyurea-Refractory Polycythemia Vera

Blood2023-11-02

Clinical outcome of biomarker-guided therapies in adult patients with tumors of the nervous system

Neuro-Oncology Advances2023-01-0117 citations

Venetoclax and idasanutlin in relapsed/refractory AML: a nonrandomized, open-label phase 1b trial

Blood2022-10-2094 citations

Hybrid-control arm construction using historical trial data for an early-phase, randomized controlled trial in metastatic colorectal cancer

Communications Medicine2022-07-1518 citations

Idasanutlin Plus Cytarabine in Relapsed or Refractory Acute Myeloid Leukemia: Results of the MIRROS Trial

Blood Advances2022-04-1268 citations

The MDM2 antagonist idasanutlin in patients with polycythemia vera: results from a single-arm phase 2 study

Blood Advances2021-12-2123 citations

Rationale and design of the CRAFT (Continuous ReAssessment with Flexible ExTension in Rare Malignancies) multicenter phase II trial

ESMO Open2021-11-1910 citations

Phase Ib/II open-label, randomized evaluation of atezolizumab (atezo) + Imprime PGG (Imprime) + bevacizumab (bev) vs regorafenib (rego) in MORPHEUS: Microsatellite-stable (MSS) metastatic colorectal cancer (mCRC).

Journal of Clinical Oncology2021-05-202 citations

Phase Ib/II open-label, randomized evaluation of efficacy and safety of atezolizumab plus isatuximab versus regorafenib in MORPHEUS-colorectal cancer.

Journal of Clinical Oncology2021-01-203 citations

Safety and Efficacy of Idasanutlin in Patients (pts) with Hydroxyurea (HU)-Resistant/Intolerant Polycythemia Vera (PV): Results of an International Phase II Study

Blood2020-11-0510 citations

Molecular Response Patterns in Hydroxyurea (HU)-Resistant or Intolerant Polycythemia Vera (PV) during Treatment with Idasanutlin: Results of an Open-Label, Single-Arm Phase 2 Study

Blood2020-11-053 citations

Combination of Idasanutlin, Venetoclax and Obinutuzumab in Patients with Relapsed or Refractory (R/R) Non-Hodgkin Lymphoma (NHL): Results from a Phase I/II Study

Blood2020-11-043 citations

Contribution of Idasanutlin Exposure to Safety, Pharmacodynamics and Clinical Response of Patients with Acute Myeloid Leukemia Treated with Idasanutlin + Cytarabine in Phase I and III Studies

Blood2020-11-043 citations

259 Phase Ib/II open-label, randomized evaluation of atezolizumab (atezo) + selicrelumab (seli) + gemcitabine+nab-paclitaxel (gem+nabP) or bevacizumab (bev) vs control in MORPHEUS-PDAC, -TNBC and -CRC

Regular and Young Investigator Award Abstracts2020-11-012 citations

MIRROS: A Randomized, Placebo-Controlled, Phase III Trial of Cytarabine ± Idasanutlin in Relapsed or Refractory Acute Myeloid Leukemia

Future Oncology2020-03-1371 citations

Phase 1 study of the MDM2 antagonist RO6839921 in patients with acute myeloid leukemia

Investigational New Drugs2020-02-0418 citations

11 more papers not shown