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NCT04200443 · OUTCOME

Clinical Benefit Rate

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
At weeks 6 and 12, then every 2 cycles up to 5 years

What was measured

Response will be evaluated in this study using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1). Per RECIST v1.1 for target lesions: Complete Response (CR), Disappearance of all target lesions. Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease; For non-target lesions, CR: Disappearance of all non-target lesions. Stable Disease (SD), Persistence of one or more non-target lesions and/or maintenance of tumor marker level above the normal limits. Clinical Benefit = CR + PR + SD. Defined as the number of patients with complete, partial response, or stable disease.

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 Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 - Patients With Unresectable or Metastatic Uterine and Non-uterine Leiomyosarcoma27Not reportedNot reportedNot reportedNot reported
Cohort 2 - Patients With Other Soft Tissue Sarcomas13Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        27
      2. group Id
        OG001
        value
        13
denoms
  1. counts
    1. group Id
      OG000
      value
      42
    2. group Id
      OG001
      value
      30
    units
    Participants
description
Response will be evaluated in this study using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1). Per RECIST v1.1 for target lesions: Complete Response (CR), Disappearance of all target lesions. Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease; For non-target lesions, CR: Disappearance of all non-target lesions. Stable Disease (SD), Persistence of one or more non-target lesions and/or maintenance of tumor marker level above the normal limits. Clinical Benefit = CR + PR + SD. Defined as the number of patients with complete, partial response, or stable disease.
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
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
At weeks 6 and 12, then every 2 cycles up to 5 years
title
Clinical Benefit Rate
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice