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NCT04200443 · FLOW

Participant flow

Cabozantinib and Temozolomide for the Treatment of Unresectable or Metastatic Leiomyosarcoma or Other Soft Tissue Sarcoma · Source last updated 2026-05-01

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Patients received oral cabozantinib 40 mg (as a starting dose) once per day and temozolomide 150 mg/m² on days 1-5 of a 28-day cycle for cycle one. Starting from cycle two, temozolomide was escalated to 200 mg/m² on days 1-5 of each cycle, if the absolute neutrophil count was more than 1·5 × 10⁹/L and platelet count was more than 100·0 × 10⁹/L. Treatment was continued until disease progression or unacceptable drug-related toxicity.
    id
    FG000
    title
    Cohort 1 - Patients With Unresectable or Metastatic Uterine and Non-uterine Leiomyosarcoma
  2. description
    Patients with gastrointestinal stromal tumour, dermatofibrosarcoma, alveolar soft part sarcoma, kaposi sarcoma, mixed mesodermal tumour or carcinosarcoma, alveolar and embryonal rhabdomyosarcoma, and low grade sarcomas were not included. Patients received oral cabozantinib 40 mg (as a starting dose) once per day and temozolomide 150 mg/m² on days 1-5 of a 28-day cycle for cycle one. Starting from cycle two, temozolomide was escalated to 200 mg/m² on days 1-5 of each cycle, if the absolute neutrophil count was more than 1·5 × 10⁹/L and platelet count was more than 100·0 × 10⁹/L. Treatment was continued until disease progression or unacceptable drug-related toxicity.
    id
    FG001
    title
    Cohort 2 - Patients With Other Soft Tissue Sarcomas
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        42
      2. group Id
        FG001
        num Subjects
        30
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        42
      2. group Id
        FG001
        num Subjects
        30
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Between January 2020 and February 2023, 96 patients were assessed for eligibility, 24 were ineligible, and 72 were enrolled and included in the final analysis.
Complete source fields
groups
  1. description
    Patients received oral cabozantinib 40 mg (as a starting dose) once per day and temozolomide 150 mg/m² on days 1-5 of a 28-day cycle for cycle one. Starting from cycle two, temozolomide was escalated to 200 mg/m² on days 1-5 of each cycle, if the absolute neutrophil count was more than 1·5 × 10⁹/L and platelet count was more than 100·0 × 10⁹/L. Treatment was continued until disease progression or unacceptable drug-related toxicity.
    id
    FG000
    title
    Cohort 1 - Patients With Unresectable or Metastatic Uterine and Non-uterine Leiomyosarcoma
  2. description
    Patients with gastrointestinal stromal tumour, dermatofibrosarcoma, alveolar soft part sarcoma, kaposi sarcoma, mixed mesodermal tumour or carcinosarcoma, alveolar and embryonal rhabdomyosarcoma, and low grade sarcomas were not included. Patients received oral cabozantinib 40 mg (as a starting dose) once per day and temozolomide 150 mg/m² on days 1-5 of a 28-day cycle for cycle one. Starting from cycle two, temozolomide was escalated to 200 mg/m² on days 1-5 of each cycle, if the absolute neutrophil count was more than 1·5 × 10⁹/L and platelet count was more than 100·0 × 10⁹/L. Treatment was continued until disease progression or unacceptable drug-related toxicity.
    id
    FG001
    title
    Cohort 2 - Patients With Other Soft Tissue Sarcomas
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        42
      2. group Id
        FG001
        num Subjects
        30
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        42
      2. group Id
        FG001
        num Subjects
        30
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Between January 2020 and February 2023, 96 patients were assessed for eligibility, 24 were ineligible, and 72 were enrolled and included in the final analysis.

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

Preserved source evidence · Not medical advice