Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02567656 · OUTCOME

Safety of 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
28 days

What was measured

Number of participants with Treatment-Related Adverse Events as Assessed by CTACE v4.0

Analysis population: DLT assessment performed in patients who participated in dose escalation phase; A toxicity will be considered dose-limiting if it occurs during the first cycle (4-weeks) treatment with Tenalisib and is considered related to Tenalisib.

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 mg4
Dose escalation_Cohort 2_400 mg4
Dose escalation_Cohort 3_800 mg (Fasting)5
Dose escalation_Cohort 4_800 mg (Fed)6
Dose expansion_PTCL_800 mg (Fasting)0
Dose expansion_CTCL_800 mg (Fasting)0

Reported measurements

Source class 1

No.of Participants with Dose Limiting Toxicities

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose escalation_Cohort 1_200 mg0Not reportedNot reportedNot reportedNot reported
Dose escalation_Cohort 2_400 mg0Not reportedNot reportedNot reportedNot reported
Dose escalation_Cohort 3_800 mg (Fasting)0Not reportedNot reportedNot reportedNot reported
Dose escalation_Cohort 4_800 mg (Fed)2Not reportedNot reportedNot reportedNot reported
Dose expansion_PTCL_800 mg (Fasting)0Not reportedNot reportedNot reportedNot reported
Dose expansion_CTCL_800 mg (Fasting)0Not reportedNot reportedNot reportedNot reported

No.of Participants without Dose Limiting Toxicitie

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose escalation_Cohort 1_200 mg4Not reportedNot reportedNot reportedNot reported
Dose escalation_Cohort 2_400 mg4Not reportedNot reportedNot reportedNot reported
Dose escalation_Cohort 3_800 mg (Fasting)5Not reportedNot reportedNot reportedNot reported
Dose escalation_Cohort 4_800 mg (Fed)4Not reportedNot reportedNot reportedNot reported
Dose expansion_PTCL_800 mg (Fasting)0Not reportedNot reportedNot reportedNot reported
Dose expansion_CTCL_800 mg (Fasting)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      title
      No.of Participants with Dose Limiting Toxicities
    2. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      title
      No.of Participants without Dose Limiting Toxicitie
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      5
    4. group Id
      OG003
      value
      6
    5. group Id
      OG004
      value
      0
    6. group Id
      OG005
      value
      0
    units
    Participants
description
Number of participants with Treatment-Related Adverse Events as Assessed by CTACE v4.0
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
DLT assessment performed in patients who participated in dose escalation phase; A toxicity will be considered dose-limiting if it occurs during the first cycle (4-weeks) treatment with Tenalisib and is considered related to Tenalisib.
reporting Status
POSTED
time Frame
28 days
title
Safety of RP6530
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice