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NCT05397171 · OUTCOME

Maximum Observed Concentration (Cmax) of AZD8853

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
MEAN
Unit
Micrograms per milliliter (ug/mL)
Interval / dispersion
Standard Deviation
Time frame
0 hour, 15 minutes, 2 hours, 6 hours, 24 hours, 168 hours and 336 hours post EOI of Cycle 1 (each cycle equals to 21 days)

What was measured

The pharmacokinetic (PK) (Cmax) of AZD8853 in serum when administered in participants with selected advanced/metastatic solid tumors were assessed. This outcome measure was assessed only for substudy 1 Part A.

Analysis population: PK analysis set included all participants who received at least one dose of IP with at least one reportable concentration.

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 Micrograms per milliliter (ug/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
AZD8853 300 mg76.703.439Not reportedNot reportedNot reported
AZD8853 1000 mg339.596.74Not reportedNot reportedNot reported
AZD8853 3000 mg1121225.9Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.439
        value
        76.70
      2. group Id
        OG001
        spread
        96.74
        value
        339.5
      3. group Id
        OG002
        spread
        225.9
        value
        1121
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 pharmacokinetic (PK) (Cmax) of AZD8853 in serum when administered in participants with selected advanced/metastatic solid tumors were assessed. This outcome measure was assessed only for substudy 1 Part A.
dispersion Type
Standard Deviation
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
MEAN
population Description
PK analysis set included all participants who received at least one dose of IP with at least one reportable concentration.
reporting Status
POSTED
time Frame
0 hour, 15 minutes, 2 hours, 6 hours, 24 hours, 168 hours and 336 hours post EOI of Cycle 1 (each cycle equals to 21 days)
title
Maximum Observed Concentration (Cmax) of AZD8853
type
SECONDARY
unit Of Measure
Micrograms per milliliter (ug/mL)

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

Preserved source evidence · Not medical advice