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NCT04200443 · OUTCOME

Overall Survival (OS)

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.

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Up to 2 years

What was measured

Will assess the time from the first dose of the study treatment until death from any cause, up to a maximum follow-up of two years.

Groups in this outcome

Cohort 1 - Patients With Unresectable or Metastatic Uterine and Non-uterine Leiomyosarcoma

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.

Cohort 2 - Patients With Other Soft Tissue Sarcomas

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Cohort 1 - Patients With Unresectable or Metastatic Uterine and Non-uterine Leiomyosarcoma42
Cohort 2 - Patients With Other Soft Tissue Sarcomas30

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 1 - Patients With Unresectable or Metastatic Uterine and Non-uterine Leiomyosarcoma19.2Not reported11.4NAUpper limit can not be estimated due to insufficient number of patients with events.
Cohort 2 - Patients With Other Soft Tissue Sarcomas7.7Not reported4.810.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Upper limit can not be estimated due to insufficient number of patients with events.
        group Id
        OG000
        lower Limit
        11.4
        upper Limit
        NA
        value
        19.2
      2. group Id
        OG001
        lower Limit
        4.8
        upper Limit
        10.9
        value
        7.7
denoms
  1. counts
    1. group Id
      OG000
      value
      42
    2. group Id
      OG001
      value
      30
    units
    Participants
description
Will assess the time from the first dose of the study treatment until death from any cause, up to a maximum follow-up of two years.
dispersion Type
95% Confidence Interval
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
    OG000
    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
    OG001
    title
    Cohort 2 - Patients With Other Soft Tissue Sarcomas
param Type
MEDIAN
reporting Status
POSTED
time Frame
Up to 2 years
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice