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NCT04105010 · OUTCOME

Part A and Part B: PFS Assessed by Investigator

Assessing An Oral Janus Kinase Inhibitor, AZD4205 as Monotherapy in Patients Who Have PTCL (JACKPOT8) · Source last updated 2025-04-04

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Up to approximately 3 years

What was measured

PFS is the time from the date of first dosing until the date of objective disease progression or death (by any cause) regardless of whether the participant discontinues the study treatments. Progression is identified based on CT and/or PET scans evaluated by investigator per Lugano criteria.

Analysis population: Part A: Safety Analysis Set Part B: Evaluable for Survival Set

Groups in this outcome

AZD4205 Group A

Group A: Open label AZD4205 at 150 mg, once daily (Phase 1) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions

AZD4205 Group B

Group B: Open label AZD4205 at 250 mg, once daily (Phase 1) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions

AZD4205 Group C

Group C: Open label AZD4205 at 150 mg, once daily (Phase 1) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions

AZD4205 Group D

Group D: Open label AZD4205 at 150 mg (RP2D), once daily (Phase 2) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions

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

Analysis denominator · Participants

GroupSource count
AZD4205 Group A28
AZD4205 Group B16
AZD4205 Group C7
AZD4205 Group D105

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
AZD4205 Group A3.29Not reported1.313.58Not reported
AZD4205 Group B2.50Not reported1.41NANot estimable due to insufficient number of participants with events
AZD4205 Group C3.32Not reported1.415.26Not reported
AZD4205 Group D3.4Not reported1.75.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.31
        upper Limit
        3.58
        value
        3.29
      2. comment
        Not estimable due to insufficient number of participants with events
        group Id
        OG001
        lower Limit
        1.41
        upper Limit
        NA
        value
        2.50
      3. group Id
        OG002
        lower Limit
        1.41
        upper Limit
        5.26
        value
        3.32
      4. group Id
        OG003
        lower Limit
        1.7
        upper Limit
        5.6
        value
        3.4
denoms
  1. counts
    1. group Id
      OG000
      value
      28
    2. group Id
      OG001
      value
      16
    3. group Id
      OG002
      value
      7
    4. group Id
      OG003
      value
      105
    units
    Participants
description
PFS is the time from the date of first dosing until the date of objective disease progression or death (by any cause) regardless of whether the participant discontinues the study treatments. Progression is identified based on CT and/or PET scans evaluated by investigator per Lugano criteria.
dispersion Type
95% Confidence Interval
groups
  1. description
    Group A: Open label AZD4205 at 150 mg, once daily (Phase 1) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions
    id
    OG000
    title
    AZD4205 Group A
  2. description
    Group B: Open label AZD4205 at 250 mg, once daily (Phase 1) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions
    id
    OG001
    title
    AZD4205 Group B
  3. description
    Group C: Open label AZD4205 at 150 mg, once daily (Phase 1) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions
    id
    OG002
    title
    AZD4205 Group C
  4. description
    Group D: Open label AZD4205 at 150 mg (RP2D), once daily (Phase 2) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions
    id
    OG003
    title
    AZD4205 Group D
param Type
MEDIAN
population Description
Part A: Safety Analysis Set Part B: Evaluable for Survival Set
reporting Status
POSTED
time Frame
Up to approximately 3 years
title
Part A and Part B: PFS Assessed by Investigator
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice