Selinexor (KPT-330) in Older Patients With Relapsed AML (SOPRA)
|ClinicalTrials.gov Identifier: NCT02088541|
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : May 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia (AML)||Drug: Selinexor Drug: Hydroxyurea Drug: Ara-C Drug: azacitidine Drug: Decitabine||Phase 2|
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).
Patients 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||171 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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/Refractory Acute Myeloid Leukemia (AML) Who Are Ineligible for Intensive Chemotherapy and/or Transplantation|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||January 8, 2018|
|Actual Study Completion Date :||January 8, 2018|
Experimental: Selinexor (KPT-330)
60 mg twice weekly (Monday and Wednesday or Tuesday and Thursday or Wednesday and Friday).
Other Name: KPT-330
Active Comparator: Physician's Choice
One of the following 3 conventional care regimens will be selected by the physician:
Other Name: Hydroxycarbamide
- Overall survival [ Time Frame: From the date of randomization until the date of death, or study end (up to approximately 104 weeks) ]To determine overall survival (OS) of Selinexor as compared to physician choice (PC).
- 3 month survival [ Time Frame: up to 3 months ]Survival at 3 months post-randomization
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088541
Show 78 Study Locations
|Study Director:||Michael Kauffman, MD, Ph.D||Karyopharm Therapeutics Inc|