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rigosertib

DRUG10 trials

Sponsors

Traws Pharma, Inc., M.D. Anderson Cancer Center, Icahn School of Medicine at Mount Sinai, Vanderbilt-Ingram Cancer Center

Conditions

Acute Lymphocytic LeukemiaAcute Myelocytic LeukemiaAdenocarcinomaAnal Squamous Cell CarcinomaAnemiaCervical Squamous Cell CarcinomaChronic Myeloid LeukemiaClinical Stage III Cutaneous Melanoma AJCC v8

Phase 1

Safety and Efficacy of 72-hour and 120-hour Infusion of Rigosertib in Acute Myeloid Leukemia (AML) and Acute Lymphoid Leukemia (ALL)
CompletedNCT01167166
Traws Pharma, Inc.Acute Lymphocytic Leukemia, Acute Myelocytic Leukemia, Chronic Myeloid Leukemia +1
Start: 2010-07-31End: 2014-06-30Updated: 2017-06-26
Safety, Pharmacokinetics and Clinical Activity of Oral Rigosertib in Solid Tumors
CompletedNCT01168011
Traws Pharma, Inc.Solid Tumor
Start: 2010-07-31End: 2015-12-31Updated: 2017-06-23
Metabolism and Excretion of [14C]-Rigosertib After Infusion to Volunteers
CompletedNCT02030639
Traws Pharma, Inc.Healthy
Start: 2014-01-31End: 2015-08-31Updated: 2017-06-23
Three Dosing Schedules of Oral Rigosertib in MDS Patients
WithdrawnNCT02075034
Traws Pharma, Inc.Myelodysplastic Syndrome
Start: 2014-05-31End: 2019-11-30Updated: 2020-07-01
Rigosertib Plus Nivolumab for KRAS+ NSCLC Patients Who Progressed on First-Line Treatment
CompletedNCT04263090
Icahn School of Medicine at Mount SinaiAdenocarcinoma, Non-small Cell Lung Cancer, Stage IV
Start: 2020-06-29End: 2023-12-20Updated: 2024-05-09

Phase 2

Efficacy and Safety of Oral Rigosertib in Transfusion-dependent, Low or Int-1 or Trisomy 8 Int-2 Myelodysplastic Syndrome
CompletedNCT01584531
Traws Pharma, Inc.MDS, Myelodysplastic Syndrome, Trisomy 8
Start: 2012-05-31End: 2015-11-30Updated: 2017-06-26
Oral Rigosertib for Squamous Cell Carcinoma
CompletedNCT01807546
Traws Pharma, Inc.Anal Squamous Cell Carcinoma, Cervical Squamous Cell Carcinoma, Esophageal Squamous Cell Carcinoma +4
Start: 2013-03-31End: 2016-04-30Updated: 2017-06-26
Single-Arm Study of the Efficacy and Safety of Oral Rigosertib in Patients With Myelofibrosis (MF) and Anemia
TerminatedNCT02730884
M.D. Anderson Cancer CenterAnemia, Leukemia, Myelofibrosis +1
Start: 2017-08-16End: 2019-08-22Updated: 2020-08-07
Rigosertib Plus Pembrolizumab in Treating Patients With Unresectable/Metastatic Melanoma Refractory to PD-1 Inhibitors
TerminatedNCT05764395
Vanderbilt-Ingram Cancer CenterClinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Melanoma +2
Start: 2023-05-09End: 2026-03-13Updated: 2026-09-16

Phase 3

Controlled Study of Rigosertib Versus Physician's Choice of Treatment in MDS Patients After Failure of an HMA
TerminatedNCT02562443
Traws Pharma, Inc.MDS, Myelodysplastic Syndrome, RAEB +1
Start: 2015-12-02End: 2021-07-26Updated: 2022-09-26

Related Papers

Abstract 2033: Rigosertib promotes anti-tumor activity of cancer cells via CETSA revealed novel targets and activates NLRP3-dependent inflammatory responses
Cancer Research2024-03-22
Mutational Landscape of MDS Patients with HMA Failure Revealed By the Correlative Analysis from Inspire Trial
Blood2021-11-051 citations
Novel induction of CD40 expression by tumor cells with RAS/RAF/PI3K pathway inhibition augments response to checkpoint blockade.
2021-06-0634 citations
The Inspire Study in Higher-Risk Myelodysplastic Syndrome (HR-MDS): A Novel Phase 3 Study Adaptive Design for Hematological Malignancies in Adults
Blood2019-11-131 citations
Genomic Profiling in Patients with Higher-Risk Myelodysplastic Syndrome (HR-MDS) Following HMA Failure: Baseline Results from the Inspire Study (04-30)
Blood2019-11-131 citations
Evaluation of Underlying Cause of Genitourinary (GU) Adverse Events (AEs) in Patients with Myelodysplastic Syndromes upon Oral Administration of Rigosertib: Safety and Pharmacokinetic Analysis of Rigosertib across Three Clinical Trials
Blood2018-11-293 citations
INSPIRE: A randomized phase III trial of intravenous rigosertib in patients with higher-risk myelodysplastic syndromes (HR-MDS) after failure of hypomethylating agents (HMAs)—Study design informed by subgroup analyses of ONTIME.
Journal of Clinical Oncology2016-05-20