Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03395080 · OUTCOME

Number of Subjects With Objective Response Rate (ORR) in Carcinosarcoma (MMMT) 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, 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 300mg Monotherapy in Carcinosarcoma

300mg DKN-01 monotherapy 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 300mg Monotherapy in Carcinosarcoma1
DKN-01 600mg Monotherapy in Carcinosarcoma8
DKN-01 300mg + Paclitaxel in Carcinosarcoma4
DKN-01 600mg + Paclitaxel in Carcinosarcoma10

Reported measurements

Confirmed ORR
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DKN-01 300mg Monotherapy in Carcinosarcoma0Not reportedNot reportedNot reportedNot reported
DKN-01 600mg Monotherapy in Carcinosarcoma0Not reportedNot reportedNot reportedNot reported
DKN-01 300mg + Paclitaxel in Carcinosarcoma1Not reportedNot reportedNot reportedNot reported
DKN-01 600mg + Paclitaxel in Carcinosarcoma1Not reportedNot reportedNot reportedNot reported
Complete Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DKN-01 300mg Monotherapy in Carcinosarcoma0Not reportedNot reportedNot reportedNot reported
DKN-01 600mg Monotherapy in Carcinosarcoma0Not reportedNot reportedNot reportedNot reported
DKN-01 300mg + Paclitaxel in Carcinosarcoma0Not reportedNot reportedNot reportedNot reported
DKN-01 600mg + Paclitaxel in Carcinosarcoma0Not reportedNot reportedNot reportedNot reported
Partial Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DKN-01 300mg Monotherapy in Carcinosarcoma0Not reportedNot reportedNot reportedNot reported
DKN-01 600mg Monotherapy in Carcinosarcoma0Not reportedNot reportedNot reportedNot reported
DKN-01 300mg + Paclitaxel in Carcinosarcoma1Not reportedNot reportedNot reportedNot reported
DKN-01 600mg + Paclitaxel in Carcinosarcoma1Not reportedNot reportedNot reportedNot reported
Stable Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DKN-01 300mg Monotherapy in Carcinosarcoma1Not reportedNot reportedNot reportedNot reported
DKN-01 600mg Monotherapy in Carcinosarcoma1Not reportedNot reportedNot reportedNot reported
DKN-01 300mg + Paclitaxel in Carcinosarcoma0Not reportedNot reportedNot reportedNot reported
DKN-01 600mg + Paclitaxel in Carcinosarcoma4Not reportedNot reportedNot reportedNot reported
Progressive Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DKN-01 300mg Monotherapy in Carcinosarcoma0Not reportedNot reportedNot reportedNot reported
DKN-01 600mg Monotherapy in Carcinosarcoma7Not reportedNot reportedNot reportedNot reported
DKN-01 300mg + Paclitaxel in Carcinosarcoma3Not reportedNot reportedNot reportedNot reported
DKN-01 600mg + Paclitaxel in Carcinosarcoma5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
    title
    Confirmed ORR
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      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
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
    title
    Partial Response
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        4
    title
    Stable Disease
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        5
    title
    Progressive Disease
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      8
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      10
    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 carcinosarcoma. DKN-01 administered by IV infusion.
    id
    OG000
    title
    DKN-01 300mg Monotherapy in Carcinosarcoma
  2. description
    600mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
    id
    OG001
    title
    DKN-01 600mg Monotherapy in Carcinosarcoma
  3. description
    300mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
    id
    OG002
    title
    DKN-01 300mg + Paclitaxel in Carcinosarcoma
  4. description
    600mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
    id
    OG003
    title
    DKN-01 600mg + Paclitaxel in Carcinosarcoma
param Type
NUMBER
population Description
Evaluable Analysis Set, 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 Carcinosarcoma (MMMT) Patients
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice