Phase I Study to Assess the Tolerability and Efficacy of Selinexor (KPT-330) as Single Agent to Eliminate Minimal Residual Disease and Maintain Remission in Patients With AML and High Risk MDS After Allogeneic Stem Cell Transplantation
Phase of Trial: Phase I
Latest Information Update: 28 Jul 2017
At a glance
- Drugs Selinexor (Primary)
- Indications Acute myeloid leukaemia; Myelodysplastic syndromes
- Focus Adverse reactions
- 24 Jul 2017 Planned End Date changed from 1 Aug 2017 to 1 Nov 2018.
- 24 Jul 2017 Planned primary completion date changed from 1 Aug 2017 to 1 Nov 2018.
- 10 Mar 2017 According to a Karyopharm Therapeutics media release, the FDA has placed selinexor (KPT-330) trials on partial clinical hold due to incomplete information in the existing version of the investigator's brochure (IB), Karyopharm has amended the IB and updated the informed consent documents accordingly and submitted to the FDA as requested.