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NCT05397171 · FLOW

Participant flow

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.

groups
  1. description
    Participants with advanced/metastatic solid tumors received AZD8853 300 milligrams (mg) every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
    id
    FG000
    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
    FG001
    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
    FG002
    title
    AZD8853 3000 mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        3
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        3
      type
      Study Terminated By Sponsor
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        7
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        7
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants who met the inclusion criteria and none of the exclusion criteria were enrolled to the study. All study assessments were performed as per the schedule of assessment. Due to early termination of the study, only Part A was started, Parts B \& C were not started.
recruitment Details
This study was conducted from 07 Jun 2022 to 06 Jun 2023 at multiple centers in the United States of America and Canada.
Complete source fields
groups
  1. description
    Participants with advanced/metastatic solid tumors received AZD8853 300 milligrams (mg) every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
    id
    FG000
    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
    FG001
    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
    FG002
    title
    AZD8853 3000 mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        3
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        3
      type
      Study Terminated By Sponsor
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        7
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        7
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants who met the inclusion criteria and none of the exclusion criteria were enrolled to the study. All study assessments were performed as per the schedule of assessment. Due to early termination of the study, only Part A was started, Parts B \& C were not started.
recruitment Details
This study was conducted from 07 Jun 2022 to 06 Jun 2023 at multiple centers in the United States of America and Canada.

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Preserved source evidence · Not medical advice