WHO ICTRP trial
A study to assess the efficacy and safety of ON 01910.Na given by continuous…
EUCTR2010-019755-21-BE · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2010-019755-21-BE |
|---|---|
| Public title | A study to assess the efficacy and safety of ON 01910.Na given by continuous intravenous infusion for 72 hours every other week in patients with a blood disease who have failed, or are resistant to, or intolerant to Azacitidine or Decitabine treatments. |
| Scientific title | A Phase III, Multi-Center, Randomized, Controlled Study to Assess the Efficacy and Safety of ON 01910.Na Administered as a 72-Hour Continuous Intravenous Infusion Every Other Week in Myelodysplastic Syndrome Patients with Excess Blasts Relapsing After, or Refractory to, or Intolerant to Azacitidine… |
| Primary sponsor | Onconova Therapeutics Inc. |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Countries | United States;France;Spain;Belgium;Germany |
| Conditions | Myelodysplastic syndrome with excess blasts MedDRA version: 16.1 Level: HLT Classification code 10028536 Term: Myelodysplastic syndromes System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] |
| Interventions | Product Code: ON01910.Na Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: N/A CAS Number: 592542-60-1 Current Sponsor code: ON 01910.Na Other descriptive name: Rigosertib Concentration unit: mg/ml… |
| Registration date | Sep 11, 2011 |
| Target size | 270 |
| Secondary IDs | 04-21 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: