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NCT03395080 · OUTCOME

Number of Subjects With Objective Disease Control Rate (ODCR) 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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline to study completion (approximately 6 months)

What was measured

Objective Disease Control Rate (ODCR) was defined as the percentage of subjects with a 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), 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), or Stable Disease (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as Progressive Disease) 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.

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

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DKN-01 Monotherapy in Recurrent EEC11Not 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
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 Carcinosarcoma1Not 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
        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
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
    5. group Id
      OG004
      value
      1
    6. group Id
      OG005
      value
      8
    7. group Id
      OG006
      value
      4
    8. group Id
      OG007
      value
      10
    units
    Participants
description
Objective Disease Control Rate (ODCR) was defined as the percentage of subjects with a 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), 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), or Stable Disease (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as Progressive Disease) 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
  5. description
    300mg DKN-01 monotherapy 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
COUNT_OF_PARTICIPANTS
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 Disease Control Rate (ODCR) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice