Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02567656 · OUTCOME

Duration of Response (DOR) With RP6530

Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T-cell Lymphoma · Source last updated 2020-01-13

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

Measure
MEDIAN
Unit
Days
Interval / dispersion
Full Range
Time frame
24 months

What was measured

The time period from the response achieved in patient until the disease progression.

Analysis population: Duration of Response (DoR) is defined as the time when the measurement criteria are first met for PR or CR (whichever is reported first) until the date of documented disease progression or death. Overall number of Participants analyzed for DoR will be the participants who met response as CR or PR

Groups in this outcome

Dose escalation_Cohort 1_200 mg

RP6530 administered 200 mg orally twice a day.

Dose escalation_Cohort 2_400 mg

RP6530 administered 400 mg orally twice a day.

Dose escalation_Cohort 3_800 mg (Fasting)

RP6530 administered 800 mg orally twice a day under fasting condition

Dose escalation_Cohort 4_800 mg (Fed)

RP6530 administered 800 mg orally twice a day under fed condition

Dose expansion_PTCL_800 mg (Fasting)

RP6530 administered 800 mg orally twice a day under fasting condition

Dose expansion_CTCL_800 mg (Fasting)

RP6530 administered 800 mg orally twice a day under fasting condition

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

Analysis denominator · Participants

GroupSource count
Dose escalation_Cohort 1_200 mg1
Dose escalation_Cohort 2_400 mg2
Dose escalation_Cohort 3_800 mg (Fasting)2
Dose escalation_Cohort 4_800 mg (Fed)2
Dose expansion_PTCL_800 mg (Fasting)4
Dose expansion_CTCL_800 mg (Fasting)5

Reported measurements

Source class 1
Values in Days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Dose escalation_Cohort 1_200 mg147Not reported147147Not reported
Dose escalation_Cohort 2_400 mg72Not reported29115Not reported
Dose escalation_Cohort 3_800 mg (Fasting)313Not reported68557Not reported
Dose escalation_Cohort 4_800 mg (Fed)99Not reported50148Not reported
Dose expansion_PTCL_800 mg (Fasting)141Not reported56391Not reported
Dose expansion_CTCL_800 mg (Fasting)307Not reported67588Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        147
        upper Limit
        147
        value
        147
      2. group Id
        OG001
        lower Limit
        29
        upper Limit
        115
        value
        72
      3. group Id
        OG002
        lower Limit
        68
        upper Limit
        557
        value
        313
      4. group Id
        OG003
        lower Limit
        50
        upper Limit
        148
        value
        99
      5. group Id
        OG004
        lower Limit
        56
        upper Limit
        391
        value
        141
      6. group Id
        OG005
        lower Limit
        67
        upper Limit
        588
        value
        307
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      2
    4. group Id
      OG003
      value
      2
    5. group Id
      OG004
      value
      4
    6. group Id
      OG005
      value
      5
    units
    Participants
description
The time period from the response achieved in patient until the disease progression.
dispersion Type
Full Range
groups
  1. description
    RP6530 administered 200 mg orally twice a day.
    id
    OG000
    title
    Dose escalation_Cohort 1_200 mg
  2. description
    RP6530 administered 400 mg orally twice a day.
    id
    OG001
    title
    Dose escalation_Cohort 2_400 mg
  3. description
    RP6530 administered 800 mg orally twice a day under fasting condition
    id
    OG002
    title
    Dose escalation_Cohort 3_800 mg (Fasting)
  4. description
    RP6530 administered 800 mg orally twice a day under fed condition
    id
    OG003
    title
    Dose escalation_Cohort 4_800 mg (Fed)
  5. description
    RP6530 administered 800 mg orally twice a day under fasting condition
    id
    OG004
    title
    Dose expansion_PTCL_800 mg (Fasting)
  6. description
    RP6530 administered 800 mg orally twice a day under fasting condition
    id
    OG005
    title
    Dose expansion_CTCL_800 mg (Fasting)
param Type
MEDIAN
population Description
Duration of Response (DoR) is defined as the time when the measurement criteria are first met for PR or CR (whichever is reported first) until the date of documented disease progression or death. Overall number of Participants analyzed for DoR will be the participants who met response as CR or PR
reporting Status
POSTED
time Frame
24 months
title
Duration of Response (DOR) With RP6530
type
SECONDARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice