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NCT02494570 · OUTCOME

Duration of Response

A Phase 2 Study of Nab-sirolimus (ABI-009) in Patients With Advanced Malignant PEComa · Source last updated 2023-04-07

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
From Initial response until tumor progression, through study completion (up to 72 months)

What was measured

The time from the start of CR or PR to the first date of documented PD or death.

Analysis population: Patients with a confirmed partial or complete response

Groups in this outcome

Experimental: Nab-Sirolimus

Patients with malignant PEComa were treated with 100 mg/m2 nab-sirolimus (30 mins IV infusion) on Days 1 and 8 in a 21-day cycle.

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

Analysis denominator · Participants

GroupSource count
Experimental: Nab-Sirolimus12

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Experimental: Nab-Sirolimus39.7Not reported6.5NAUpper limit was not reached due to insufficient number of participants with events
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Upper limit was not reached due to insufficient number of participants with events
        group Id
        OG000
        lower Limit
        6.5
        upper Limit
        NA
        value
        39.7
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    units
    Participants
description
The time from the start of CR or PR to the first date of documented PD or death.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients with malignant PEComa were treated with 100 mg/m2 nab-sirolimus (30 mins IV infusion) on Days 1 and 8 in a 21-day cycle.
    id
    OG000
    title
    Experimental: Nab-Sirolimus
param Type
MEDIAN
population Description
Patients with a confirmed partial or complete response
reporting Status
POSTED
time Frame
From Initial response until tumor progression, through study completion (up to 72 months)
title
Duration of Response
type
SECONDARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice