NCT02088541

Selinexor (KPT-330) in Older Patients With Relapsed AML

A Randomized, Open Label, Phase 2 Study of the Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330) Versus Specified Physician's Choice in Patients ≥ 60 Years Old With Relapsed or Refractory Acute Myeloid Leukemia (AML) Who Are Ineligible for Intensive Chemotherapy and/or Transplantation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 317 (actual)
• Sponsor: Karyopharm Therapeutics Inc · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, multicenter, open-label, phase 2 study of the SINE compound, selinexor given orally versus specified investigator choices (one of three potential salvage therapies). Participants age ≥ 60 years with relapsed or refractory AML of any type except for AML M3, after one prior therapy only, who have never undergone and who are not currently eligible for stem cell transplantation and are currently deemed unfit for intensive chemotherapy.

Detailed description

This is a randomized, multicenter, open-label phase 2 study of the SINE compound, selinexor given orally versus restricted investigator choice (i.e., one of three potential salvage therapies). Participants who have never been transplant eligible, are currently deemed unfit for intensive chemotherapy, ≥ 60 years old, who have AML (except Acute Promyelocytic Leukemia: APL, AML M3) after one prior treatment of either hypomethylating agent or a regimen including Ara-C, and are meeting the inclusion and exclusion criteria will be randomized to receive either oral selinexor or physician's choice (one of three potential treatments: best supportive care (BSC) alone, or BSC + hypomethylating agent, or BSC + low dose Ara-C until disease progression, death or intolerance has occurred.

Conditions

• Acute Myeloid Leukemia (AML)

Interventions

Type	Name	Description
DRUG	Selinexor	Selinexor oral tablet.
DRUG	Hydroxyurea
DRUG	Ara-C	Ara-C Subcutaneous Injection.

Timeline

• Start date: 2014-03-01
• Primary completion: 2018-01-08
• Completion: 2018-01-08
• First posted: 2014-03-17
• Last updated: 2023-01-26
• Results posted: 2020-10-08

Locations

78 sites across 11 countries: United States, Canada, Denmark, France, Germany, Israel, Italy, Netherlands, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study