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NCT02567656 · OUTCOME

Overall Response Rate (ORR) 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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
8 months

What was measured

ORR is defined as sum of CR and PR rates, Response assessment for PTCL based on IWG criteria (Cheson 2007) and CTCL on mSWAT/Global assessment (ISCL/EORTC guideline).

Analysis population: Patients were considered for efficacy analysis as per protocol only if they had one post treatment efficacy assessment at C3D1

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 mg3
Dose escalation_Cohort 2_400 mg2
Dose escalation_Cohort 3_800 mg (Fasting)3
Dose escalation_Cohort 4_800 mg (Fed)5
Dose expansion_PTCL_800 mg (Fasting)10
Dose expansion_CTCL_800 mg (Fasting)12

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose escalation_Cohort 1_200 mg1Not reportedNot reportedNot reportedNot reported
Dose escalation_Cohort 2_400 mg2Not reportedNot reportedNot reportedNot reported
Dose escalation_Cohort 3_800 mg (Fasting)2Not reportedNot reportedNot reportedNot reported
Dose escalation_Cohort 4_800 mg (Fed)2Not reportedNot reportedNot reportedNot reported
Dose expansion_PTCL_800 mg (Fasting)4Not reportedNot reportedNot reportedNot reported
Dose expansion_CTCL_800 mg (Fasting)5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      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
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      5
    5. group Id
      OG004
      value
      10
    6. group Id
      OG005
      value
      12
    units
    Participants
description
ORR is defined as sum of CR and PR rates, Response assessment for PTCL based on IWG criteria (Cheson 2007) and CTCL on mSWAT/Global assessment (ISCL/EORTC guideline).
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
COUNT_OF_PARTICIPANTS
population Description
Patients were considered for efficacy analysis as per protocol only if they had one post treatment efficacy assessment at C3D1
reporting Status
POSTED
time Frame
8 months
title
Overall Response Rate (ORR) With RP6530
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice