A Phase I/II, Multi-center, Dose-escalating Study of the Tolerability, Pharmacokinetics, and Clinical Activity of the Combined Administration of Oral Rigosertib With Azacitidine in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia

Trial Profile

A Phase I/II, Multi-center, Dose-escalating Study of the Tolerability, Pharmacokinetics, and Clinical Activity of the Combined Administration of Oral Rigosertib With Azacitidine in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 07 Dec 2017

At a glance

  • Drugs Rigosertib (Primary) ; Azacitidine; Azacitidine
  • Indications Acute myeloid leukaemia; Chronic myelomonocytic leukaemia; Myelodysplastic syndromes
  • Focus Adverse reactions; First in man; Pharmacokinetics
  • Sponsors Onconova Therapeutics
  • Most Recent Events

    • 09 Nov 2017 According to an Onconova Therapeutics media release, based on the progress of this trial the Company has decided to limit the trial to US sites. Initial data from this study will be presented at a scientific conference in early 2018
    • 09 Nov 2017 The company is awaiting the results of this trial (see profile 236134) before proceeding further for a Phase III trials (see profile 277199), as reported in an Onconova Therapeutics media release. The company expects completing this trial in the fourth quarter of 2017.
    • 15 Aug 2017 According to an Onconova Therapeutics media release, first patient was enrolled in the expansion phase of this study in April. Currently four sites are open in U.S, and the company plans to open additional sites in US, Europe and Australia.
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