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NCT03206177 · OUTCOME

Objective Response

Paclitaxel/Carboplatin + Galunisertib for Patients With Carcinosarcoma of the Uterus or Ovary · Source last updated 2024-08-07

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

Measure
NUMBER
Unit
proportion of patients with CR/PR
Interval / dispersion
95% Confidence Interval
Time frame
within three years of study entry

What was measured

Proportion of patients who had RECIST documented partial or complete response. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be ≥ 10 mm when measured by CT and MRI; or ≥ 20 mm when measured by conventional techniques, including plain x-ray. Response was documented per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions.

Analysis population: Patients who received four cycles of study drugs

Groups in this outcome

Paclitaxel/Carboplatin + Galunisertib

Galunisertib: Galunisertib 150mg po BID day 4-17 Paclitaxel: Paclitaxel 175 mg/m2 over 3 hours Carboplatin: IV day 1 Carboplatin AUC 6\* over 1 hour (or 5\* if prior radiation therapy)

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

Analysis denominator · Participants

GroupSource count
Paclitaxel/Carboplatin + Galunisertib21

Reported measurements

Source class 1
Values in proportion of patients with CR/PR · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Paclitaxel/Carboplatin + Galunisertib0.33Not reported0.150.57Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.15
        upper Limit
        0.57
        value
        0.33
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    units
    Participants
description
Proportion of patients who had RECIST documented partial or complete response. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be ≥ 10 mm when measured by CT and MRI; or ≥ 20 mm when measured by conventional techniques, including plain x-ray. Response was documented per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions.
dispersion Type
95% Confidence Interval
groups
  1. description
    Galunisertib: Galunisertib 150mg po BID day 4-17 Paclitaxel: Paclitaxel 175 mg/m2 over 3 hours Carboplatin: IV day 1 Carboplatin AUC 6\* over 1 hour (or 5\* if prior radiation therapy)
    id
    OG000
    title
    Paclitaxel/Carboplatin + Galunisertib
param Type
NUMBER
population Description
Patients who received four cycles of study drugs
reporting Status
POSTED
time Frame
within three years of study entry
title
Objective Response
type
SECONDARY
unit Of Measure
proportion of patients with CR/PR

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

Preserved source evidence · Not medical advice