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NCT02494570 · OUTCOME

Progression-free Survival Rate at 6 Months

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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
6 months

What was measured

The time from the first dose date to the first observation of a disease progression or death due to any cause by 6 mo. Disease progression was assessed radiologically per RECIST v1.1, and was defined as ≥20% increase in the sum of diameters of target lesions, and absolute increase of ≥5 mm. PFS rate at 6 months was summarized using Kaplan-Meier methods (percentage rounded up to 1 digit decimal).

Analysis population: Efficacy Evaluable Patient Population

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-Sirolimus31

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Experimental: Nab-Sirolimus69.5Not reported47.683.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        47.6
        upper Limit
        83.7
        value
        69.5
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    units
    Participants
description
The time from the first dose date to the first observation of a disease progression or death due to any cause by 6 mo. Disease progression was assessed radiologically per RECIST v1.1, and was defined as ≥20% increase in the sum of diameters of target lesions, and absolute increase of ≥5 mm. PFS rate at 6 months was summarized using Kaplan-Meier methods (percentage rounded up to 1 digit decimal).
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
NUMBER
population Description
Efficacy Evaluable Patient Population
reporting Status
POSTED
time Frame
6 months
title
Progression-free Survival Rate at 6 Months
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice