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NCT03395080 · OUTCOME

Number of Subjects With Objective Response Rate (ORR) in EEC or EOC Patients

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
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Baseline to study completion (approximately 6 months)

What was measured

Best overall response of Complete Response (CR; disappearance of all target lesions, any pathological lymph nodes whether target or non-target must have reduction in short axis to \<10mm) or Partial Response (PR; at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1)

Analysis population: Evaluable Analysis Set (EAS), all subjects who received any amount of DKN-01 and had at least 1 evaluated post-baseline RECIST assessment or were discontinued due to death.

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.

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 EEC26
DKN-01 + Paclitaxel in Recurrent EEC21
DKN-01 Monotherapy in Recurrent EOC13
DKN-01 + Paclitaxel in Recurrent EOC19

Reported measurements

ORR
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DKN-01 Monotherapy in Recurrent EEC2Not reportedNot reportedNot reportedNot reported
DKN-01 + Paclitaxel in Recurrent EEC0Not reportedNot reportedNot reportedNot reported
DKN-01 Monotherapy in Recurrent EOC0Not reportedNot reportedNot reportedNot reported
DKN-01 + Paclitaxel in Recurrent EOC0Not reportedNot reportedNot reportedNot reported
Complete Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DKN-01 Monotherapy in Recurrent EEC1Not reportedNot reportedNot reportedNot reported
DKN-01 + Paclitaxel in Recurrent EEC0Not reportedNot reportedNot reportedNot reported
DKN-01 Monotherapy in Recurrent EOC0Not reportedNot reportedNot reportedNot reported
DKN-01 + Paclitaxel in Recurrent EOC0Not reportedNot reportedNot reportedNot reported
Partial Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DKN-01 Monotherapy in Recurrent EEC1Not reportedNot reportedNot reportedNot reported
DKN-01 + Paclitaxel in Recurrent EEC0Not reportedNot reportedNot reportedNot reported
DKN-01 Monotherapy in Recurrent EOC0Not reportedNot reportedNot reportedNot reported
DKN-01 + Paclitaxel in Recurrent EOC0Not reportedNot reportedNot reportedNot reported
Stable Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DKN-01 Monotherapy in Recurrent EEC9Not reportedNot reportedNot reportedNot reported
DKN-01 + Paclitaxel in Recurrent EEC12Not reportedNot reportedNot reportedNot reported
DKN-01 Monotherapy in Recurrent EOC6Not reportedNot reportedNot reportedNot reported
DKN-01 + Paclitaxel in Recurrent EOC13Not reportedNot reportedNot reportedNot reported
Progressive Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DKN-01 Monotherapy in Recurrent EEC15Not reportedNot reportedNot reportedNot reported
DKN-01 + Paclitaxel in Recurrent EEC9Not reportedNot reportedNot reportedNot reported
DKN-01 Monotherapy in Recurrent EOC7Not reportedNot reportedNot reportedNot reported
DKN-01 + Paclitaxel in Recurrent EOC6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    ORR
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    Complete Response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    Partial Response
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        13
    title
    Stable Disease
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        7
      4. group Id
        OG003
        value
        6
    title
    Progressive Disease
denoms
  1. counts
    1. group Id
      OG000
      value
      26
    2. group Id
      OG001
      value
      21
    3. group Id
      OG002
      value
      13
    4. group Id
      OG003
      value
      19
    units
    Participants
description
Best overall response of Complete Response (CR; disappearance of all target lesions, any pathological lymph nodes whether target or non-target must have reduction in short axis to \<10mm) or Partial Response (PR; at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1)
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
param Type
NUMBER
population Description
Evaluable Analysis Set (EAS), all subjects who received any amount of DKN-01 and had at least 1 evaluated post-baseline RECIST assessment or were discontinued due to death.
reporting Status
POSTED
time Frame
Baseline to study completion (approximately 6 months)
title
Number of Subjects With Objective Response Rate (ORR) in EEC or EOC Patients
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice