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NCT03395080 · FLOW

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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.

groups
  1. description
    300mg DKN-01 monotherapy in recurrent EEC. DKN-01 administered by IV infusion.
    id
    FG000
    title
    DKN-01 Monotherapy in Recurrent EEC
  2. description
    300mg DKN-01+paclitaxel in recurrent EEC. DKN-01 administered by IV infusion.
    id
    FG001
    title
    DKN-01+Paclitaxel in Recurrent EEC
  3. description
    300mg DKN-01 monotherapy in recurrent EOC. DKN-01 administered by IV infusion.
    id
    FG002
    title
    DKN-01 Monotherapy in Recurrent EOC
  4. description
    300mg DKN-01+paclitaxel in recurrent EOC. DKN-01and paclitaxel administered by IV infusion.
    id
    FG003
    title
    DKN-01+Paclitaxel in Recurrent EOC
  5. description
    300mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
    id
    FG004
    title
    DKN-01 300mg Monotherapy in Carcinosarcoma
  6. description
    600mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
    id
    FG005
    title
    DKN-01 600mg Monotherapy in Carcinosarcoma
  7. description
    300mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
    id
    FG006
    title
    DKN-01 300mg + Paclitaxel in Carcinosarcoma
  8. description
    600mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
    id
    FG007
    title
    DKN-01 600 mg + Paclitaxel in Carcinosarcoma
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        29
      2. group Id
        FG001
        num Subjects
        24
      3. group Id
        FG002
        num Subjects
        14
      4. group Id
        FG003
        num Subjects
        19
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        8
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        12
      comment
      Number Started is the Safety Analysis Set defined as all subjects who received \>= 1 administration of assigned study treatment (DKN-01 or paclitaxel).Subjects with carcinosarcoma were initially enrolled in the EEC group to receive monotherapy or DKN-01+paclitaxel, but as part of a subsequent protocol amendment, carcinosarcoma subjects were enrolled \& received 600mg DKN-01 or 600mg DKN-01+paclitaxel. Results are reported by disease type and treatment received.
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        26
      2. group Id
        FG001
        num Subjects
        21
      3. group Id
        FG002
        num Subjects
        13
      4. group Id
        FG003
        num Subjects
        19
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        8
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        10
      comment
      Number Completed is the Evaluable Analysis Set defined as 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.
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    300mg DKN-01 monotherapy in recurrent EEC. DKN-01 administered by IV infusion.
    id
    FG000
    title
    DKN-01 Monotherapy in Recurrent EEC
  2. description
    300mg DKN-01+paclitaxel in recurrent EEC. DKN-01 administered by IV infusion.
    id
    FG001
    title
    DKN-01+Paclitaxel in Recurrent EEC
  3. description
    300mg DKN-01 monotherapy in recurrent EOC. DKN-01 administered by IV infusion.
    id
    FG002
    title
    DKN-01 Monotherapy in Recurrent EOC
  4. description
    300mg DKN-01+paclitaxel in recurrent EOC. DKN-01and paclitaxel administered by IV infusion.
    id
    FG003
    title
    DKN-01+Paclitaxel in Recurrent EOC
  5. description
    300mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
    id
    FG004
    title
    DKN-01 300mg Monotherapy in Carcinosarcoma
  6. description
    600mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
    id
    FG005
    title
    DKN-01 600mg Monotherapy in Carcinosarcoma
  7. description
    300mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
    id
    FG006
    title
    DKN-01 300mg + Paclitaxel in Carcinosarcoma
  8. description
    600mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
    id
    FG007
    title
    DKN-01 600 mg + Paclitaxel in Carcinosarcoma
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        29
      2. group Id
        FG001
        num Subjects
        24
      3. group Id
        FG002
        num Subjects
        14
      4. group Id
        FG003
        num Subjects
        19
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        8
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        12
      comment
      Number Started is the Safety Analysis Set defined as all subjects who received \>= 1 administration of assigned study treatment (DKN-01 or paclitaxel).Subjects with carcinosarcoma were initially enrolled in the EEC group to receive monotherapy or DKN-01+paclitaxel, but as part of a subsequent protocol amendment, carcinosarcoma subjects were enrolled \& received 600mg DKN-01 or 600mg DKN-01+paclitaxel. Results are reported by disease type and treatment received.
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        26
      2. group Id
        FG001
        num Subjects
        21
      3. group Id
        FG002
        num Subjects
        13
      4. group Id
        FG003
        num Subjects
        19
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        8
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        10
      comment
      Number Completed is the Evaluable Analysis Set defined as 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.
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Overall Study

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

Preserved source evidence · Not medical advice