Numerous clinical trials evaluate oral and intravenous rigosertib across oncological and dermatological indications—including myelodysplastic syndromes, squamous cell carcinomas, advanced cutaneous melanoma, and recessive dystrophic epidermolysis bullosa—spanning Early Phase 1 to Phase 3 studies as monotherapy or combined with chemotherapy. Sponsored by pharmaceutical entities such as Traws Pharma, Inc. alongside academic medical centers like Thomas Jefferson University, M.D. Anderson Cancer Center, and Mount Sinai, these protocols encompass active, recruiting, completed, terminated, and withdrawn statuses.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05764395 | ACTIVE_NOT_RECRUITING | Clinical Stage III Cutaneous Melanoma AJCC v8; Clinical Stage IV Cutaneous Melanoma AJCC v8; Metastatic Melanoma; Refractory Melanoma; Unresectable Melanoma |
Vanderbilt-Ingram Cancer Center |
2023-05-09 | PHASE2 |
| NCT03786237 | COMPLETED | Epidermolysis Bullosa Dystrophica; Squamous Cell Carcinoma |
Prof. Johann Bauer |
2021-04-12 | PHASE1; PHASE2 |
| NCT04177498 | COMPLETED | Recessive Dystrophic Epidermolysis Bullosa |
Thomas Jefferson University |
2021-08-24 | EARLY_PHASE1 |
| NCT04263090 | COMPLETED | Non-small Cell Lung Cancer; Adenocarcinoma; Stage IV |
Icahn School of Medicine at Mount Sinai |
2020-06-29 | PHASE1; PHASE2 |
| NCT04177498 | Recruiting | Recessive Dystrophic Epidermolysis Bullosa |
Thomas Jefferson University|Traws Pharma Inc. |
2021-08-24 | Early Phase 1 |
| NCT01926587 | COMPLETED | Myelodysplastic Syndrome; Acute Myeloid Leukemia; Chronic Myelomonocytic Leukemia |
Traws Pharma, Inc. |
2013-08 | PHASE1; PHASE2 |
| NCT01904682 | COMPLETED | Myelodysplastic Syndromes |
Traws Pharma, Inc. |
2013-07 | PHASE2 |
| NCT02562443 | TERMINATED | Myelodysplastic Syndrome; MDS; Refractory Anemia With Excess Blasts; RAEB |
Traws Pharma, Inc. |
2015-12-02 | PHASE3 |
| NCT02730884 | TERMINATED | Leukemia; Myelofibrosis; Anemia; Splenomegaly |
M.D. Anderson Cancer Center |
2017-08-16 | PHASE2 |
| NCT02075034 | WITHDRAWN | Myelodysplastic Syndrome |
Traws Pharma, Inc. |
2014-05 | PHASE1 |
| NCT01241500 | COMPLETED | Myelodysplastic Syndromes; MDS; RAEB; Chronic Myelomonocytic Leukemia |
Traws Pharma, Inc. |
2010-11 | PHASE3 |
| NCT01928537 | COMPLETED | Myelodysplastic Syndromes; Refractory Anemia With Excess Blasts; Chronic Myelomonocytic Leukemia; Cytopenia |
Traws Pharma, Inc. |
2013-08 | PHASE3 |
| NCT01168011 | COMPLETED | Solid Tumor |
Traws Pharma, Inc. |
2010-07 | PHASE1 |
| NCT01360853 | COMPLETED | Metastatic Pancreatic Adenocarcinoma |
Traws Pharma, Inc. |
2011-05 | PHASE3 |
| NCT01584531 | COMPLETED | Myelodysplastic Syndrome; MDS; Trisomy 8 |
Traws Pharma, Inc. |
2012-05 | PHASE2 |
| NCT01807546 | COMPLETED | Head and Neck Squamous Cell Carcinoma; Anal Squamous Cell Carcinoma; Lung Squamous Cell Carcinoma; Cervical Squamous Cell Carcinoma; Esophageal Squamous Cell Carcinoma; Skin Squamous Cell Carcinoma; Penile Squamous Cell Carcinoma |
Traws Pharma, Inc. |
2013-03 | PHASE2 |
| NCT02030639 | COMPLETED | Healthy |
Traws Pharma, Inc. |
2014-01 | PHASE1 |
| NCT00854646 | COMPLETED | Acute Myelocytic Leukemia; Acute Lymphocytic Leukemia; Chronic Myelocytic Leukemia; Chronic Lymphocytic Leukemia; Myelodysplastic Syndromes |
Traws Pharma, Inc. |
2008-10 | PHASE1 |
| NCT01048619 | COMPLETED | Myelodysplastic Syndrome |
Traws Pharma, Inc. |
2009-12 | PHASE1 |
| NCT02107235 | COMPLETED | Head and Neck Neoplasms; Carcinoma, Squamous Cell |
Traws Pharma, Inc. |
2014-01 | PHASE1 |
| NCT02075034 | Withdrawn | Myelodysplastic Syndrome |
Traws Pharma Inc. |
2014-05 | Phase 1 |
| NCT02030639 | Completed | Healthy |
Traws Pharma Inc. |
2014-01 | Phase 1 |
| NCT01167166 | COMPLETED | Acute Myelocytic Leukemia; Acute Lymphocytic Leukemia; Myeloproliferative Disease; Chronic Myeloid Leukemia |
Traws Pharma, Inc. |
2010-07 | PHASE1; PHASE2 |
| NCT00906334 | COMPLETED | Myelodysplastic Syndrome |
Traws Pharma, Inc. |
2009-05 | PHASE2 |
| NCT00854945 | COMPLETED | Myelodysplastic Syndrome; Acute Myeloid Leukemia |
Traws Pharma, Inc. |
2009-01 | PHASE1; PHASE2 |
| NCT01928537 | Completed | Myelodysplastic Syndromes|Refractory Anemia With Excess Blasts|Chronic Myelomonocytic Leukemia|Cytopenia |
Traws Pharma Inc. |
2013-08 | Phase 3 |
| NCT01807546 | Completed | Head and Neck Squamous Cell Carcinoma|Anal Squamous Cell Carcinoma|Lung Squamous Cell Carcinoma|Cervical Squamous Cell Carcinoma|Esophageal Squamous Cell Carcinoma|Skin Squamous Cell Carcinoma|Penile Squamous Cell Carcinoma |
Traws Pharma Inc. |
2013-03 | Phase 2 |
| NCT00861510 | COMPLETED | Lymphoma, Mantle-cell; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Hairy Cell; Waldenstrom Macroglobulinemia; Multiple Myeloma |
National Heart, Lung, and Blood Institute (NHLBI) |
2009-03-05 | PHASE1 |
| NCT00533416 | COMPLETED | Myelodysplastic Syndrome (MDS) |
National Heart, Lung, and Blood Institute (NHLBI) |
2007-09-14 | PHASE1 |
| NCT01125891 | COMPLETED | Malignant Neoplasmas; Solid Tumors |
Traws Pharma, Inc. |
2009-01 | PHASE1 |
| NCT00856791 | COMPLETED | Ovarian Cancer |
Traws Pharma, Inc. |
2009-03 | PHASE2 |
| NCT00861783 | COMPLETED | Hepatoma; Advanced Solid Tumor |
Traws Pharma, Inc. |
2008-06 | PHASE1 |
| NCT01165905 | COMPLETED | Solid Tumor |
Traws Pharma, Inc. |
2010-01 | PHASE1 |
| NCT00861328 | COMPLETED | Advanced Solid Tumors |
Traws Pharma, Inc. |
2008-02 | PHASE1 |
| NCT01538537 | COMPLETED | Advanced Cancer; Solid Tumors; Cancer; Neoplasms |
Traws Pharma, Inc. |
2006-08 | PHASE1 |
| NCT01538563 | COMPLETED | Solid Tumors; Advanced Cancer; Cancer; Neoplasms |
Traws Pharma, Inc. |
2006-06 | PHASE1 |
| NCT01168011 | Completed | Solid Tumor |
Traws Pharma Inc. |
2010-07 | Phase 1 |
| NCT00867061 | WITHDRAWN | Myelodysplastic Syndrome |
Traws Pharma, Inc. |
2009-03 | PHASE1; PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-04-27)
Check the
Rigosertib Sodium (ON-01910)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- Rigosertib Sodium (ON-01910) Solubility in DMSO
- Rigosertib Sodium (ON-01910) Stock Solution
- Rigosertib Sodium (ON-01910) Storage
- Rigosertib Sodium (ON-01910) Stability
- Rigosertib Sodium (ON-01910) Molecular Weight
- Rigosertib Sodium (ON-01910) SMILES
- Rigosertib Sodium (ON-01910) CAS Number
- Rigosertib Sodium (ON-01910) Chemical Structure (2D and 3D)
- Rigosertib Sodium (ON-01910) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.