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NCT02075034
A Randomized Phase I Study to Assess the Pharmacokinetics, Tolerability, Efficacy and Pharmacodynamics of Three Dosing Schedules of Oral Rigosertib in Transfusion-dependent, Low, Intermediate 1, or Intermediate-2 Myelodysplastic Syndrome Patients Based on the International Prognostic Scoring System
Phase 1 trial testing rigosertib in Myelodysplastic Syndrome. Withdrawn.
1 August 2019
Quick facts
| Lead sponsor | Traws Pharma, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Start date | 1 May 2014 |
| Primary completion | 1 August 2019 |
| Estimated completion | 1 November 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- rigosertib — full drug profile →
Conditions studied
- Myelodysplastic Syndrome — all drugs for Myelodysplastic Syndrome →
Sponsor
Traws Pharma, Inc. — full company profile →
Who can join
18 and older, any sex, with Myelodysplastic Syndrome. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Micrograms of rigosertib per milliliter of plasma
Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, and 8 hour on Day 1 of Cycle 1 and on Day 1 of Cycle 2.
Concentration of rigosertib in plasma will be determined by validated high performance liquid chromatography (HPLC) method. -
Micrograms of rigosertib per milliliter of urine
Time frame: Cycle 1 Day 1 and Cycle 2 Day 1 in dosing Regimens 1 and 2 and Cycle 1 Day 1 and Cycle 2 Day 21 in dose Regimen 3
Concentration of rigosertib in urine will be determined by a validated high performance liquid chromatography (HPLC) method. -
Number of patients with adverse events
Time frame: Until 30 days after last dose of study drug (up to 52 weeks)
Adverse events will be summarized by worst grade according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. All AE presentations will summarize treatment-emergent adverse events (TEAEs), defined as AEs with onset on or after first dose, or onset prior to first dose but with worsening severity after first dose.
Sponsor's own description
This study will compare the dosing regimen of oral rigosertib, which has been used in other studies of lower risk Myelodysplastic Syndrome (MDS), with 2 new dosing regimens to determine if one of the new regimens gives improved results as measured by disease status, side effects, and analyses of blood and urine samples.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Targeting PI3K in cancer: mechanisms and advances in clinical trials.
Yang J, Nie J, Ma X, Wei Y, et al · · 2019 · cited 1142× · PMID 30782187 · DOI 10.1186/s12943-019-0954-x
Verify or expand the search:
- PubMed search for NCT02075034
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of rigosertib
Trials testing the same drug.
- NCT02562443 — Controlled Study of Rigosertib Versus Physician's Choice of Treatment in MDS Patients After Failure of an HMA · Phase 3 · terminated
Other recruiting trials for Myelodysplastic Syndrome
Currently open trials in the same condition.
- NCT07020533 — A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Pa · Phase 1 · recruiting
- NCT07422480 — A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myel · Phase 3 · recruiting
- NCT07107126 — Safety and Proof-of-Concept Study of RPT1G in Adults With Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndromes · Phase 1 · recruiting
- NCT06781099 — Feasibility Trial of Extracorporeal Iron Purification in Patients With Myelodysplastic Syndrome or Myelofibrosis · NA · recruiting
- NCT07285044 — The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Tr · Phase 2 · recruiting
Other Traws Pharma, Inc. trials
Trials by the same sponsor.
- NCT06757738 — A Clinical Study Aiming to Assess Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of TRX-100 in Healthy Volu · Phase 1 · completed
- NCT06402136 — Evaluation Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of 83-0060 in Healthy Volun · Phase 1 · completed
- NCT02562443 — Controlled Study of Rigosertib Versus Physician's Choice of Treatment in MDS Patients After Failure of an HMA · Phase 3 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02075034 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Traws Pharma, Inc.
- Last refreshed: 29 June 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02075034.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing