27 completed, 3 terminated, 1 withdrawn. 19 Phase 1, 12 Phase 2, 4 Phase 3, 1 Early Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 19 | Completed 18, Withdrawn 1 |
| Phase 2 | 12 | Completed 10, Terminated 2 |
| Phase 3 | 4 | Completed 3, Terminated 1 |
| Early Phase 1 | 1 | Completed 1 |
Follow ON 01910: new trials by email Literature Review of ON 01910 trials Research Report on ON 01910
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Rigosertib Plus Pembrolizumab in Treating Patients With Unresectable/Metastatic Melanoma Refractory to PD-1 Inhibitors Rigosertib, Pembrolizumab, Magnetic Resonance Imaging - Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8 | Phase 2 | Terminated | Vanderbilt-Ingram Cancer Center | 7 | 2023-05-09 | 2026-09-16 |
| Rigosertib in Patients With Recessive Dystrophic Epidermolysis Bullosa Associated SCC Rigosertib Sodium, Quality-of-Life Assessment - Recessive Dystrophic Epidermolysis Bullosa | Early Phase 1 | Completed | Thomas Jefferson University | 3 | 2021-08-24 | 2025-08-01 |
| Rigosertib for RDEB-SCC Rigosertib Oral Capsules / Rigosertib Intravenous - Epidermolysis Bullosa Dystrophica, Squamous Cell Carcinoma | Phase 1 / Phase 2 | Completed | Prof. Johann Bauer | 2 | 2021-04-12 | 2026-02-24 |
| Rigosertib Plus Nivolumab for KRAS+ NSCLC Patients Who Progressed on First-Line Treatment Rigosertib, Nivolumab - Non-small Cell Lung Cancer, Adenocarcinoma | Phase 1 / Phase 2 | Completed | Icahn School of Medicine at Mount Sinai | 25 | 2020-06-29 | 2024-05-09 |
| Single-Arm Study of the Efficacy and Safety of Oral Rigosertib in Patients With Myelofibrosis (MF) and Anemia Rigosertib, Questionnaire - Leukemia, Myelofibrosis | Phase 2 | Terminated | M.D. Anderson Cancer Center | 3 | 2017-08-16 | 2020-08-07 |
| Controlled Study of Rigosertib Versus Physician's Choice of Treatment in MDS Patients After Failure of an HMA rigosertib, Any approved or standard-of-care therapy, best supportive care (BSC) - Myelodysplastic Syndrome, MDS | Phase 3 | Terminated | Traws Pharma, Inc. | 372 | 2015-12-02 | 2022-09-26 |
| Three Dosing Schedules of Oral Rigosertib in MDS Patients rigosertib - Myelodysplastic Syndrome | Phase 1 | Withdrawn | Traws Pharma, Inc. | 2014-05-01 | 2020-07-01 | |
| Metabolism and Excretion of [14C]-Rigosertib After Infusion to Volunteers rigosertib - Healthy | Phase 1 | Completed | Traws Pharma, Inc. | 6 | 2014-01-01 | 2017-06-23 |
| Platinum-based Chemoradiotherapy and Rigosertib in Head and Neck Cancer oral rigosertib, cisplatin, Radiotherapy - Head and Neck Neoplasms, Carcinoma, Squamous Cell | Phase 1 | Completed | Traws Pharma, Inc. | 2 | 2014-01-01 | 2017-06-23 |
| Phase II Part 2 Expansion of Oral Rigosertib in Combination With Azacitidine oral rigosertib, Azacitidine - Myelodysplastic Syndrome, Acute Myeloid Leukemia | Phase 1 / Phase 2 | Completed | Traws Pharma, Inc. | 45 | 2013-08-01 | 2021-06-16 |
| Efficacy and Safety of IV Rigosertib in MDS Patients With Excess Blasts Progressing After Azacitidine or Decitabine rigosertib sodium - Myelodysplastic Syndromes, Refractory Anemia With Excess Blasts | Phase 3 | Completed | Traws Pharma, Inc. | 67 | 2013-08-01 | 2020-06-30 |
| Oral Rigosertib in Low Risk MDS Patients Refractory to ESAs Oral rigosertib - Myelodysplastic Syndromes | Phase 2 | Completed | Traws Pharma, Inc. | 45 | 2013-07-01 | 2021-06-16 |
| Oral Rigosertib for Squamous Cell Carcinoma rigosertib - Head and Neck Squamous Cell Carcinoma, Anal Squamous Cell Carcinoma | Phase 2 | Completed | Traws Pharma, Inc. | 64 | 2013-03-01 | 2017-06-26 |
| Efficacy and Safety of Oral Rigosertib in Transfusion-dependent, Low or Int-1 or Trisomy 8 Int-2 Myelodysplastic Syndrome rigosertib - Myelodysplastic Syndrome, MDS | Phase 2 | Completed | Traws Pharma, Inc. | 82 | 2012-05-01 | 2017-06-26 |
| Gemcitabine and ON 01910.Na in Previously Untreated Metastatic Pancreatic Cancer ON 01910.Na, Gemcitabine - Metastatic Pancreatic Adenocarcinoma | Phase 3 | Completed | Traws Pharma, Inc. | 160 | 2011-05-01 | 2016-08-04 |
| Randomized Study of ON 01910.Na in Refractory Myelodysplastic Syndrome Patients With Excess Blasts ON 01910.Na - Myelodysplastic Syndromes, MDS | Phase 3 | Completed | Traws Pharma, Inc. | 299 | 2010-11-01 | 2020-06-30 |
| Safety, Pharmacokinetics and Clinical Activity of Oral Rigosertib in Solid Tumors rigosertib - Solid Tumor | Phase 1 | Completed | Traws Pharma, Inc. | 68 | 2010-07-01 | 2017-06-23 |
| Safety and Efficacy of 72-hour and 120-hour Infusion of Rigosertib in Acute Myeloid Leukemia (AML) and Acute Lymphoid Leukemia (ALL) rigosertib - Acute Myelocytic Leukemia, Acute Lymphocytic Leukemia | Phase 1 / Phase 2 | Completed | Traws Pharma, Inc. | 30 | 2010-07-01 | 2017-06-26 |
| Safety of 24-hour Infusion of ON 01910.Na in Combination With Gemcitabine in Advanced Solid Tumors ON 01910.Na, Gemcitabine - Solid Tumor | Phase 1 | Completed | Traws Pharma, Inc. | 10 | 2010-01-01 | 2017-06-23 |
| Safety and Pharmacokinetic Study of Oral ON 01910.Na in Patients With Myelodysplastic Syndrome ON 01910.Na - Myelodysplastic Syndrome | Phase 1 | Completed | Traws Pharma, Inc. | 36 | 2009-12-01 | 2017-06-23 |
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Myelodysplastic Syndromes (12) · Leukemia, Myeloid, Acute (4) · Neoplasms (4) · Anemia, Refractory, with Excess of Blasts (3) · Carcinoma, Squamous Cell (3) · Leukemia, Myelomonocytic, Chronic (3) · Chromosome 8, trisomy (2) · Cytopenia (2) · Epidermolysis Bullosa Dystrophica (2) · Head and Neck Neoplasms (2) · Leukemia (2) · Leukemia, Lymphocytic, Chronic, B-Cell (2) · Leukemia, Myelogenous, Chronic, BCR-ABL Positive (2) · Precursor Cell Lymphoblastic Leukemia-Lymphoma (2) · Primary Myelofibrosis (2)
Traws Pharma, Inc. (24) · National Heart, Lung, and Blood Institute (NHLBI) (2) · Icahn School of Medicine at Mount Sinai (1) · M.D. Anderson Cancer Center (1) · Prof. Johann Bauer (1) · Thomas Jefferson University (1) · Vanderbilt-Ingram Cancer Center (1)
United States (30) · France (5) · Germany (4) · Italy (3) · Spain (3) · Australia (2) · Austria (2) · Belgium (2) · Hungary (2) · India (2) · Russia (2) · Sweden (2) · Canada (1) · Croatia (1) · Czechia (1)
Steven M. Fruchtman, MD (6) · Antonio Jimeno, MD, PhD (4) · Sridhar Mani, MD (3) · Azra Raza, MD (2) · Jorge Cortes, MD (2) · Douglas Johnson, MD (1) · Francois Wilhelm, MD, PhD (1) · Gregory P. Sutton, MD (1) · Johann W Bauer, Prof., MD (1) · Lawrence P. Leichman, MD (1) · Lewis R. Silverman, MD (1) · Mark Heaney, MD (1) · Mark J Roschewski, M.D. (1) · Michael Kurman, MD (1) · Neal S Young, M.D. (1)
PMID 27400247, PMID 24777753, PMID 21924492, PMID 22338014, PMID 22524974, PMID 23841031, PMID 26091808, PMID 26489442, PMID 26945010, PMID 26968357, PMID 29144985, PMID 32442785
2015 (1)