An Exploratory Phase 1 Study to Assess the Tolerability, Pharmacokinetics and Clinical Activity of ON 01910.Na Capsules Administered Orally as Escalating Single and Multiple Doses Twice a Day up to 14 Days of a 21-Day Cycle in Patients with Refractory Intermediate-1, Intermediate-2, or High Risk Myelodysplastic Syndrome.

Trial Profile

An Exploratory Phase 1 Study to Assess the Tolerability, Pharmacokinetics and Clinical Activity of ON 01910.Na Capsules Administered Orally as Escalating Single and Multiple Doses Twice a Day up to 14 Days of a 21-Day Cycle in Patients with Refractory Intermediate-1, Intermediate-2, or High Risk Myelodysplastic Syndrome.

Completed
Phase of Trial: Phase I

Latest Information Update: 01 Sep 2016

At a glance

  • Drugs Rigosertib (Primary)
  • Indications Myelodysplastic syndromes
  • Focus Pharmacokinetics
  • Sponsors Onconova Therapeutics
  • Most Recent Events

    • 21 Mar 2012 Additional lead trial centres and investigators identified as reported by Clinical Trials Registry - India.
    • 21 Mar 2012 Actual initiation date changed from Aug 2011 to Oct 2011 as reported by Clinical Trials Registry - India.
    • 27 Oct 2011 Status changed from not yet recruiting to recruiting as reported by Clinical Trials Registry - India.
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