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NCT03395080 · OUTCOME

Duration of Clinical Benefit (DoCB) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).

A Study of DKN-01 as a Monotherapy or in Combination With Paclitaxel in Patients With Recurrent Epithelial Endometrial or Epithelial Ovarian Cancer or Carcinosarcoma · Source last updated 2025-08-01

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Baseline to study completion (approximately 13.1 months)

What was measured

Duration of Clinical Benefit (DoCB) includes patients with a Best Overall Response of CR, PR, or SD and is defined as the time from the first tumor assessment of CR, PR or SD to the time of PD or death due to any cause.

Analysis population: Number of participants analyzed only includes patients who had CR, PR, or SD.

Groups in this outcome

DKN-01 Monotherapy in Recurrent EEC

300mg DKN-01 monotherapy in recurrent EEC. DKN-01 administered by IV infusion.

DKN-01 + Paclitaxel in Recurrent EEC

300mg DKN-01+paclitaxel in recurrent EEC. DKN-01 and paclitaxel administered by IV infusion.

DKN-01 Monotherapy in Recurrent EOC

300mg DKN-01 monotherapy in recurrent EOC. DKN-01 administered by IV infusion.

DKN-01 + Paclitaxel in Recurrent EOC

300mg DKN-01+paclitaxel in recurrent EOC. DKN-01 and paclitaxel administered by IV infusion.

DKN-01 300mg Monotherapy in Carcinosarcoma

300mg DKN-01 in carcinosarcoma. DKN-01 administered by IV infusion.

DKN-01 600mg Monotherapy in Carcinosarcoma

600mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.

DKN-01 300mg + Paclitaxel in Carcinsarcoma

300mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.

DKN-01 600mg + Paclitaxel in Carcinosarcoma

600mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.

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

Analysis denominator · Participants

GroupSource count
DKN-01 Monotherapy in Recurrent EEC11
DKN-01 + Paclitaxel in Recurrent EEC12
DKN-01 Monotherapy in Recurrent EOC6
DKN-01 + Paclitaxel in Recurrent EOC13
DKN-01 300mg Monotherapy in Carcinosarcoma1
DKN-01 600mg Monotherapy in Carcinosarcoma1
DKN-01 300mg + Paclitaxel in Carcinsarcoma1
DKN-01 600mg + Paclitaxel in Carcinosarcoma5

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
DKN-01 Monotherapy in Recurrent EEC4.7Not reported1.29.2Not reported
DKN-01 + Paclitaxel in Recurrent EEC3.8Not reported2.04.2Not reported
DKN-01 Monotherapy in Recurrent EOC1.9Not reported1.713.1Not reported
DKN-01 + Paclitaxel in Recurrent EOC3.9Not reported1.85.6Not reported
DKN-01 300mg Monotherapy in CarcinosarcomaNANot reportedNANASubject had a progression event; the Kaplan-Meier estimated median duration of clinical benefit times was not estimable.
DKN-01 600mg Monotherapy in Carcinosarcoma6.0Not reportedNANANA = not estimable. Data are not estimable due to insufficient number of participants with events.
DKN-01 300mg + Paclitaxel in Carcinsarcoma3.7Not reportedNANANA = not estimable. Data are not estimable due to insufficient number of participants with events.
DKN-01 600mg + Paclitaxel in Carcinosarcoma2.2Not reported1.9NANE = not estimable. Data are not estimable due to insufficient number of participants with events.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.2
        upper Limit
        9.2
        value
        4.7
      2. group Id
        OG001
        lower Limit
        2.0
        upper Limit
        4.2
        value
        3.8
      3. group Id
        OG002
        lower Limit
        1.7
        upper Limit
        13.1
        value
        1.9
      4. group Id
        OG003
        lower Limit
        1.8
        upper Limit
        5.6
        value
        3.9
      5. comment
        Subject had a progression event; the Kaplan-Meier estimated median duration of clinical benefit times was not estimable.
        group Id
        OG004
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      6. comment
        NA = not estimable. Data are not estimable due to insufficient number of participants with events.
        group Id
        OG005
        lower Limit
        NA
        upper Limit
        NA
        value
        6.0
      7. comment
        NA = not estimable. Data are not estimable due to insufficient number of participants with events.
        group Id
        OG006
        lower Limit
        NA
        upper Limit
        NA
        value
        3.7
      8. comment
        NE = not estimable. Data are not estimable due to insufficient number of participants with events.
        group Id
        OG007
        lower Limit
        1.9
        upper Limit
        NA
        value
        2.2
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    2. group Id
      OG001
      value
      12
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      13
    5. group Id
      OG004
      value
      1
    6. group Id
      OG005
      value
      1
    7. group Id
      OG006
      value
      1
    8. group Id
      OG007
      value
      5
    units
    Participants
description
Duration of Clinical Benefit (DoCB) includes patients with a Best Overall Response of CR, PR, or SD and is defined as the time from the first tumor assessment of CR, PR or SD to the time of PD or death due to any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    300mg DKN-01 monotherapy in recurrent EEC. DKN-01 administered by IV infusion.
    id
    OG000
    title
    DKN-01 Monotherapy in Recurrent EEC
  2. description
    300mg DKN-01+paclitaxel in recurrent EEC. DKN-01 and paclitaxel administered by IV infusion.
    id
    OG001
    title
    DKN-01 + Paclitaxel in Recurrent EEC
  3. description
    300mg DKN-01 monotherapy in recurrent EOC. DKN-01 administered by IV infusion.
    id
    OG002
    title
    DKN-01 Monotherapy in Recurrent EOC
  4. description
    300mg DKN-01+paclitaxel in recurrent EOC. DKN-01 and paclitaxel administered by IV infusion.
    id
    OG003
    title
    DKN-01 + Paclitaxel in Recurrent EOC
  5. description
    300mg DKN-01 in carcinosarcoma. DKN-01 administered by IV infusion.
    id
    OG004
    title
    DKN-01 300mg Monotherapy in Carcinosarcoma
  6. description
    600mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
    id
    OG005
    title
    DKN-01 600mg Monotherapy in Carcinosarcoma
  7. description
    300mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
    id
    OG006
    title
    DKN-01 300mg + Paclitaxel in Carcinsarcoma
  8. description
    600mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
    id
    OG007
    title
    DKN-01 600mg + Paclitaxel in Carcinosarcoma
param Type
MEDIAN
population Description
Number of participants analyzed only includes patients who had CR, PR, or SD.
reporting Status
POSTED
time Frame
Baseline to study completion (approximately 13.1 months)
title
Duration of Clinical Benefit (DoCB) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
type
SECONDARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice