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NCT00355472 · OUTCOME

Antitumor Effect

Phase I Study of KW-0761 in Relapsed Patients With CCR4-Positive ATL and PTCL · Source last updated 2012-10-18

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
50 days

What was measured

The antitumor response criteria (Complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD)) were created based on the criteria for non-Hodgkin's lymphoma and chronic lymphocytic leukemia provided in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology as well as the criteria for non-Hodgkin's lymphoma by the Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG).

Groups in this outcome

KW-0761 0.01mg

IV infusions of KW-0761 once/week for 4 weeks

KW-0761 0.1mg

IV infusions of KW-0761 once/week for 4 weeks

KW-0761 0.5mg

IV infusions of KW-0761 once/week for 4 weeks

KW-0761 1.0mg

IV infusions of KW-0761 once/week for 4 weeks

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

Analysis denominator · Participants

GroupSource count
KW-0761 0.01mg3
KW-0761 0.1mg4
KW-0761 0.5mg3
KW-0761 1.0mg6

Reported measurements

Complete Response (CR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
KW-0761 0.01mg0Not reportedNot reportedNot reportedNot reported
KW-0761 0.1mg1Not reportedNot reportedNot reportedNot reported
KW-0761 0.5mg0Not reportedNot reportedNot reportedNot reported
KW-0761 1.0mg1Not reportedNot reportedNot reportedNot reported
Uncertain Complete Response (CRu)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
KW-0761 0.01mg0Not reportedNot reportedNot reportedNot reported
KW-0761 0.1mg0Not reportedNot reportedNot reportedNot reported
KW-0761 0.5mg0Not reportedNot reportedNot reportedNot reported
KW-0761 1.0mg0Not reportedNot reportedNot reportedNot reported
Partial Response (PR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
KW-0761 0.01mg1Not reportedNot reportedNot reportedNot reported
KW-0761 0.1mg0Not reportedNot reportedNot reportedNot reported
KW-0761 0.5mg0Not reportedNot reportedNot reportedNot reported
KW-0761 1.0mg2Not reportedNot reportedNot reportedNot reported
Stable Disease (SD)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
KW-0761 0.01mg1Not reportedNot reportedNot reportedNot reported
KW-0761 0.1mg2Not reportedNot reportedNot reportedNot reported
KW-0761 0.5mg0Not reportedNot reportedNot reportedNot reported
KW-0761 1.0mg2Not reportedNot reportedNot reportedNot reported
Progressive Disease (PD)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
KW-0761 0.01mg1Not reportedNot reportedNot reportedNot reported
KW-0761 0.1mg1Not reportedNot reportedNot reportedNot reported
KW-0761 0.5mg3Not reportedNot reportedNot reportedNot reported
KW-0761 1.0mg1Not reportedNot reportedNot reportedNot reported
Not Evaluable (NE)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
KW-0761 0.01mg0Not reportedNot reportedNot reportedNot reported
KW-0761 0.1mg0Not reportedNot reportedNot reportedNot reported
KW-0761 0.5mg0Not reportedNot reportedNot reportedNot reported
KW-0761 1.0mg0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
    title
    Complete Response (CR)
  2. 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
        0
    title
    Uncertain Complete Response (CRu)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        2
    title
    Partial Response (PR)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        2
    title
    Stable Disease (SD)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        1
    title
    Progressive Disease (PD)
  6. 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
        0
    title
    Not Evaluable (NE)
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      6
    units
    Participants
description
The antitumor response criteria (Complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD)) were created based on the criteria for non-Hodgkin's lymphoma and chronic lymphocytic leukemia provided in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology as well as the criteria for non-Hodgkin's lymphoma by the Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG).
groups
  1. description
    IV infusions of KW-0761 once/week for 4 weeks
    id
    OG000
    title
    KW-0761 0.01mg
  2. description
    IV infusions of KW-0761 once/week for 4 weeks
    id
    OG001
    title
    KW-0761 0.1mg
  3. description
    IV infusions of KW-0761 once/week for 4 weeks
    id
    OG002
    title
    KW-0761 0.5mg
  4. description
    IV infusions of KW-0761 once/week for 4 weeks
    id
    OG003
    title
    KW-0761 1.0mg
param Type
NUMBER
reporting Status
POSTED
time Frame
50 days
title
Antitumor Effect
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice