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NCT02530476 · OUTCOME

Event Free Survival

Phase I/II, Study of Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330) + Sorafenib in Acute Myeloid Leukemia · Source last updated 2020-03-31

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
Months
Interval / dispersion
Full Range
Time frame
Up to 6 months

What was measured

Time from date of treatment start until the date of first objective documentation of disease-relapse.

Analysis population: Event Free Survival was not an objective outlined for participants in Phase I Group's 1 and 2, therefore overall survival was not done for these participants. Of the seven participants in cohort 1, one participant was not evaluable for response. Of the three participants in cohort 2, one participant was not evaluable for response.

Groups in this outcome

Phase I Group 1 Selinexor + Sorafenib

Cohort includes those with FLT3-ITD and -D835 mutated participants with relapsed/refractory AML, including participants who may have been previously exposed to one or more FLT3-inhibitors. Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Selinexor: Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I. Sorafenib: Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I.

Phase I Group 2 Selinexor + Sorafenib

Cohort includes those with FLT3-ITD and -D835 mutated participants with relapsed/refractory AML, including participants who may have been previously exposed to one or more FLT3-inhibitors. Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Phase I Group 2 received Selinexor 80 mg by mouth twice weekly for a 28 day cycle.

Cohort 1 (FLT3-ITD Inhibitor Failure Cohort)

Cohort includes those with FLT3-ITD and -D835 mutated relapsed/refractory AML who have failed therapy with up to two prior salvage regimens. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I. Selinexor: Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I. Sorafenib: Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I.

Cohort 2 (FLT3-ITD Inhibitor Naive Cohort)

Cohort includes those with FLT3-ITD and -D835 mutated relapsed/refractory AML who have failed therapy with up to two prior salvage regimens. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I. Selinexor: Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I. Sorafenib: Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Phase I Group 1 Selinexor + Sorafenib0
Phase I Group 2 Selinexor + Sorafenib0
Cohort 1 (FLT3-ITD Inhibitor Failure Cohort)6
Cohort 2 (FLT3-ITD Inhibitor Naive Cohort)2

Reported measurements

Source class 1
Values in Months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Cohort 1 (FLT3-ITD Inhibitor Failure Cohort)1.8Not reported0.45.0Not reported
Cohort 2 (FLT3-ITD Inhibitor Naive Cohort)2.1Not reported0.72.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG002
        lower Limit
        0.4
        upper Limit
        5.0
        value
        1.8
      2. group Id
        OG003
        lower Limit
        0.7
        upper Limit
        2.1
        value
        2.1
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      2
    units
    Participants
description
Time from date of treatment start until the date of first objective documentation of disease-relapse.
dispersion Type
Full Range
groups
  1. description
    Cohort includes those with FLT3-ITD and -D835 mutated participants with relapsed/refractory AML, including participants who may have been previously exposed to one or more FLT3-inhibitors. Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Selinexor: Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I. Sorafenib: Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I.
    id
    OG000
    title
    Phase I Group 1 Selinexor + Sorafenib
  2. description
    Cohort includes those with FLT3-ITD and -D835 mutated participants with relapsed/refractory AML, including participants who may have been previously exposed to one or more FLT3-inhibitors. Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Phase I Group 2 received Selinexor 80 mg by mouth twice weekly for a 28 day cycle.
    id
    OG001
    title
    Phase I Group 2 Selinexor + Sorafenib
  3. description
    Cohort includes those with FLT3-ITD and -D835 mutated relapsed/refractory AML who have failed therapy with up to two prior salvage regimens. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I. Selinexor: Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I. Sorafenib: Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I.
    id
    OG002
    title
    Cohort 1 (FLT3-ITD Inhibitor Failure Cohort)
  4. description
    Cohort includes those with FLT3-ITD and -D835 mutated relapsed/refractory AML who have failed therapy with up to two prior salvage regimens. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I. Selinexor: Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I. Sorafenib: Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I.
    id
    OG003
    title
    Cohort 2 (FLT3-ITD Inhibitor Naive Cohort)
param Type
MEDIAN
population Description
Event Free Survival was not an objective outlined for participants in Phase I Group's 1 and 2, therefore overall survival was not done for these participants. Of the seven participants in cohort 1, one participant was not evaluable for response. Of the three participants in cohort 2, one participant was not evaluable for response.
reporting Status
POSTED
time Frame
Up to 6 months
title
Event Free Survival
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice