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

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ClinicalTrials.gov Identifier: NCT02088541
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Karyopharm Therapeutics Inc

Brief 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). Patients age ≥ 60 years with relapsed/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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia (AML) Drug: Selinexor Drug: Hydroxyurea Drug: Ara-C Drug: azacitidine Drug: Decitabine Phase 2

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).

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: Selinexor (KPT-330)
60 mg twice weekly (Monday and Wednesday or Tuesday and Thursday or Wednesday and Friday).
Drug: Selinexor
Other Name: KPT-330

Active Comparator: Physician's Choice

One of the following 3 conventional care regimens will be selected by the physician:

  1. best supportive care (BSC) including blood product transfusions, antimicrobials, growth factors as needed, and hydroxyurea;
  2. BSC + low dose Ara-C, 20 mg bid by subcutaneous (sc) injection daily on days 1-10/14 days (20/28 doses) to be repeated at 28 to 42 day intervals;
  3. BSC + hypomethylating agent: azacitidine 75 mg/m2 by sc injection daily on days 1-7 (7 doses) to be repeated at 28 day intervals, or decitabine (20 mg/m2 IV over 1 hour daily on Days 1-5 to be repeated at 28 day intervals).
Drug: Hydroxyurea
Other Name: Hydroxycarbamide

Drug: Ara-C
Other Names:
  • Cytarabine
  • cytosine arabinoside
  • Cytosar-U
  • Depocyt

Drug: azacitidine
Other Names:
  • 5-azacytidine
  • Vidaza

Drug: Decitabine
Other Names:
  • Dacogen
  • 5-aza-2'-deoxycytidine,




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 3 month survival [ Time Frame: up to 3 months ]
    Survival at 3 months post-randomization



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 60 years with relapsed/refractory AML of any type except for acute promyelocytic leukemia (APL; AML M3), after at least 1 prior AML therapy , who have never undergone, and who are not currently eligible for, stem cell transplantation, and are currently deemed unfit for intensive chemotherapy.
  • ECOG ≤ 2.
  • Must have available archival or recently acquired bone marrow biopsy/aspiration or tumor tissue for central review to be eligible.
  • Relapsed or refractory AML, defined as either: recurrence of disease after a complete remission (CR), or failure to achieve CR with initial therapy.
  • Must have received at least 1 prior line of AML therapy given at standard doses and must have progressed after their most recent therapy. Prior therapy must have included: a hypomethylating agent with at least 2 cycles.
  • At least 2 weeks must have elapsed since the last anti-leukemia treatment (with the exception of hydroxyurea) before first dose in this study.

Exclusion Criteria:

  • Treatment with any investigational agent within 3 weeks prior to first dose in this study.
  • Presence of central nervous system (CNS) leukemia.
  • In blast transformation of chronic myeloid leukemia (CML). Prior myelodysplastic syndrome (MDS) is acceptable; prior treatment for MDS does not count as an AML therapy.
  • Major surgery within 2 weeks of first dose of study drug. Patients must have recovered from the effects of any surgery performed greater than 2 weeks previously.
  • Concurrent active malignancy under treatment.
  • Known active hepatitis B virus (HBV) or C virus (HCV) infection; or known to be positive for HCV ribonucleic acid (RNA) or HBsAg (HBV surface antigen).
  • Known HIV infection.
  • Unable to swallow tablets, or patients with malabsorption syndrome, or any other disease significantly affecting gastrointestinal function.
  • Patients whose AML is classified as favorable according to the European LeukemiaNet (ELN) disease risk assessment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088541


  Show 78 Study Locations
Sponsors and Collaborators
Karyopharm Therapeutics Inc
Investigators
Study Director: Michael Kauffman, MD, Ph.D Karyopharm Therapeutics Inc

Responsible Party: Karyopharm Therapeutics Inc
ClinicalTrials.gov Identifier: NCT02088541     History of Changes
Other Study ID Numbers: KCP-330-008
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Karyopharm Therapeutics Inc:
Relapsed/Refractory Acute Myeloid Leukemia
Acute Myeloid Leukemia
AML
Karyopharm
Selinexor
KPT-330

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Azacitidine
Decitabine
Hydroxyurea
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Antisickling Agents
Nucleic Acid Synthesis Inhibitors