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NCT05397171 · OUTCOME

Progression Free Survival (PFS)

A First-in-human Study to Evaluate the Safety and Tolerability of AZD8853 in Participants With Selected Advanced/Metastatic Solid Tumours · Source last updated 2024-10-01

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
Full Range
Time frame
First dose until documented disease progression or study end (1 Year)

What was measured

The PFS was defined as the time from the start of study intervention until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the participant withdraws from study intervention or received another anti-cancer therapy prior to progression. This outcome measure was assessed only for substudy 1 Part A.

Analysis population: Safety set included all participants who received any amount of IP.

Groups in this outcome

AZD8853 300 mg

Participants with advanced/metastatic solid tumors received AZD8853 300 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.

AZD8853 1000 mg

Participants with advanced/metastatic solid tumors received AZD8853 1000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.

AZD8853 3000 mg

Participants with advanced/metastatic solid tumors received AZD8853 3000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.

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

Analysis denominator · Participants

GroupSource count
AZD8853 300 mg3
AZD8853 1000 mg6
AZD8853 3000 mg7

Reported measurements

Source class 1
Values in Months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
AZD8853 300 mg1.31Not reported1.183.38Not reported
AZD8853 1000 mg1.23Not reported1.153.15Not reported
AZD8853 3000 mg1.25Not reported0.953.29Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.18
        upper Limit
        3.38
        value
        1.31
      2. group Id
        OG001
        lower Limit
        1.15
        upper Limit
        3.15
        value
        1.23
      3. group Id
        OG002
        lower Limit
        0.95
        upper Limit
        3.29
        value
        1.25
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      7
    units
    Participants
description
The PFS was defined as the time from the start of study intervention until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the participant withdraws from study intervention or received another anti-cancer therapy prior to progression. This outcome measure was assessed only for substudy 1 Part A.
dispersion Type
Full Range
groups
  1. description
    Participants with advanced/metastatic solid tumors received AZD8853 300 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
    id
    OG000
    title
    AZD8853 300 mg
  2. description
    Participants with advanced/metastatic solid tumors received AZD8853 1000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
    id
    OG001
    title
    AZD8853 1000 mg
  3. description
    Participants with advanced/metastatic solid tumors received AZD8853 3000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
    id
    OG002
    title
    AZD8853 3000 mg
param Type
MEDIAN
population Description
Safety set included all participants who received any amount of IP.
reporting Status
POSTED
time Frame
First dose until documented disease progression or study end (1 Year)
title
Progression Free Survival (PFS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice