NCT05397171 · OUTCOME

Overall Survival (OS)

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: 90% Confidence Interval
Time frame: First dose until study end (1 Year)

What was measured

Overall survival was defined as the time from the start of treatment until death due to any cause. 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

Group	Source count
AZD8853 300 mg	3
AZD8853 1000 mg	6
AZD8853 3000 mg	7

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 90% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
AZD8853 300 mg	4.47	Not reported	2.92	NA	The median and 90% CI were calculated with the Kaplan Meier process (a process in medical research to measure the proportion of participants surviving for a certain time after receiving treatment) and were non estimable at the time of analysis as there was insufficient number of participants with the event of interest (less than 50% for the median estimate) occurred in the study.
AZD8853 1000 mg	5.45	Not reported	2.30	NA	The median and 90% CI were calculated with the Kaplan Meier process (a process in medical research to measure the proportion of participants surviving for a certain time after receiving treatment) and were non estimable at the time of analysis as there was insufficient number of participants with the event of interest (less than 50% for the median estimate) occurred in the study.
AZD8853 3000 mg	NA	Not reported	0.95	NA	The median and 90% CI were calculated with the Kaplan Meier process (a process in medical research to measure the proportion of participants surviving for a certain time after receiving treatment) and were non estimable at the time of analysis as there was insufficient number of participants with the event of interest (less than 50% for the median estimate) occurred in the study.

Complete source fields

classes

categories
measurements
comment
The median and 90% CI were calculated with the Kaplan Meier process (a process in medical research to measure the proportion of participants surviving for a certain time after receiving treatment) and were non estimable at the time of analysis as there was insufficient number of participants with the event of interest (less than 50% for the median estimate) occurred in the study.
group Id
OG000
lower Limit
2.92
upper Limit
NA
value
4.47
comment
The median and 90% CI were calculated with the Kaplan Meier process (a process in medical research to measure the proportion of participants surviving for a certain time after receiving treatment) and were non estimable at the time of analysis as there was insufficient number of participants with the event of interest (less than 50% for the median estimate) occurred in the study.
group Id
OG001
lower Limit
2.30
upper Limit
NA
value
5.45
comment
The median and 90% CI were calculated with the Kaplan Meier process (a process in medical research to measure the proportion of participants surviving for a certain time after receiving treatment) and were non estimable at the time of analysis as there was insufficient number of participants with the event of interest (less than 50% for the median estimate) occurred in the study.
group Id
OG002
lower Limit
0.95
upper Limit
NA
value
NA

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
6
group Id
OG002
value
7
units
Participants

description

Overall survival was defined as the time from the start of treatment until death due to any cause. This outcome measure was assessed only for substudy 1 Part A.

dispersion Type

90% Confidence Interval

groups

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
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
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 study end (1 Year)

title

Overall Survival (OS)

type

SECONDARY

unit Of Measure

Months

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

Preserved source evidence · Not medical advice