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NCT03395080 · OUTCOME

Duration of Response (DoR) 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 11 months)

What was measured

Duration of Response (DoR) includes only patients that have responded with an objective disease response (PR or CR) and is defined as the time from the first tumor assessment that supports the patient's objective disease response to the time of PD or death due to any cause.

Analysis population: Number of participants analyzed only includes the responders in each group.

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 Eecurrent 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 Carcinosarcoma

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 EEC2
DKN-01 + Paclitaxel in Recurrent EEC0
DKN-01 Monotherapy in Recurrent EOC0
DKN-01 + Paclitaxel in Eecurrent EOC0
DKN-01 300mg Monotherapy in Carcinosarcoma0
DKN-01 600mg Monotherapy in Carcinosarcoma0
DKN-01 300mg + Paclitaxel in Carcinosarcoma1
DKN-01 600mg + Paclitaxel in Carcinosarcoma1

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
DKN-01 Monotherapy in Recurrent EECNANot reportedNANANA = Insufficient number of participants with events. 2 subjects with responses, but only one with an event, Median duration of response could not be estimated as 1 of the 2 subjects response had not had a progression event, therefore the 95% CIs are not estimable. 1 patient remains in response at end of study.
DKN-01 300mg + Paclitaxel in Carcinosarcoma3.7Not reportedNANAPR was reported for 1 subject with a progression event therefore no CIs are estimable
DKN-01 600mg + Paclitaxel in CarcinosarcomaNANot reportedNANAInsufficient number of participants with events. Median duration of response could not be estimated as the 1 subject with PR had not had a progression event.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        NA = Insufficient number of participants with events. 2 subjects with responses, but only one with an event, Median duration of response could not be estimated as 1 of the 2 subjects response had not had a progression event, therefore the 95% CIs are not estimable. 1 patient remains in response at end of study.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        PR was reported for 1 subject with a progression event therefore no CIs are estimable
        group Id
        OG006
        lower Limit
        NA
        upper Limit
        NA
        value
        3.7
      3. comment
        Insufficient number of participants with events. Median duration of response could not be estimated as the 1 subject with PR had not had a progression event.
        group Id
        OG007
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    5. group Id
      OG004
      value
      0
    6. group Id
      OG005
      value
      0
    7. group Id
      OG006
      value
      1
    8. group Id
      OG007
      value
      1
    units
    Participants
description
Duration of Response (DoR) includes only patients that have responded with an objective disease response (PR or CR) and is defined as the time from the first tumor assessment that supports the patient's objective disease response 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 Eecurrent 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 Carcinosarcoma
  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 the responders in each group.
reporting Status
POSTED
time Frame
Baseline to study completion (approximately 11 months)
title
Duration of Response (DoR) 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