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NCT00552396 · OUTCOME

Maximum Tolerated Dose (MTD) of IPH2101 as Determined by Number of Participants With Dose-Limiting Toxicities (DLTs) Related to IPH2101 Treatment

An Open-label, Dose-escalation Safety and Tolerability Trial Assessing Anti-KIR (1-7F9) in Subjects With Multiple Myeloma · Source last updated 2016-03-31

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

Measure
NUMBER
Unit
Number of participants with DLT
Interval / dispersion
Not reported
Time frame
From start of the treatment to end of study

What was measured

The maximum tolerated dose (MTD) is the highest dose level below the maximum administered dose (MAD) where none or 1 out of 6 subjects have a DLT.

Analysis population: All treated participants who received at least one dose of the study drug and were evaluable for DLT

Groups in this outcome

IPH2101 0.0003 mg/kg

Participants were administered an IV dose of 0.0003 mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.

IPH2101 0.003 mg/kg

Participants were administered an IV dose of 0.003 mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.

IPH2101 0.015 mg/kg

Participants were administered an IV dose of 0.015 mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.

IPH2101 0.075 mg/kg

Participants were administered an IV dose of 0.075 mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.

IPH2101 0.3mg/kg

Participants were administered an IV dose of 0.3mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.

IPH2101 1mg/kg

Participants were administered an IV dose of 1 mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.

IPH2101 3 mg/kg

Participants were administered an IV dose of 3mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level.If MTD this is not reached at 3mg/kg, 7 subjects will be enrolled at this dose to obtain more data from a larger subject pool to better evaluate safety, PK, PD and signs of efficacy.

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

Analysis denominator · Participants

GroupSource count
IPH2101 0.0003 mg/kg4
IPH2101 0.003 mg/kg3
IPH2101 0.015 mg/kg3
IPH2101 0.075 mg/kg6
IPH2101 0.3mg/kg3
IPH2101 1mg/kg3
IPH2101 3 mg/kg10

Reported measurements

Source class 1
Values in Number of participants with DLT · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
IPH2101 0.0003 mg/kg0Not reportedNot reportedNot reportedNot reported
IPH2101 0.003 mg/kg0Not reportedNot reportedNot reportedNot reported
IPH2101 0.015 mg/kg0Not reportedNot reportedNot reportedNot reported
IPH2101 0.075 mg/kg1Not reportedNot reportedNot reportedNot reported
IPH2101 0.3mg/kg0Not reportedNot reportedNot reportedNot reported
IPH2101 1mg/kg0Not reportedNot reportedNot reportedNot reported
IPH2101 3 mg/kg0Not 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
        1
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      6
    5. group Id
      OG004
      value
      3
    6. group Id
      OG005
      value
      3
    7. group Id
      OG006
      value
      10
    units
    Participants
description
The maximum tolerated dose (MTD) is the highest dose level below the maximum administered dose (MAD) where none or 1 out of 6 subjects have a DLT.
groups
  1. description
    Participants were administered an IV dose of 0.0003 mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.
    id
    OG000
    title
    IPH2101 0.0003 mg/kg
  2. description
    Participants were administered an IV dose of 0.003 mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.
    id
    OG001
    title
    IPH2101 0.003 mg/kg
  3. description
    Participants were administered an IV dose of 0.015 mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.
    id
    OG002
    title
    IPH2101 0.015 mg/kg
  4. description
    Participants were administered an IV dose of 0.075 mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.
    id
    OG003
    title
    IPH2101 0.075 mg/kg
  5. description
    Participants were administered an IV dose of 0.3mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.
    id
    OG004
    title
    IPH2101 0.3mg/kg
  6. description
    Participants were administered an IV dose of 1 mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.
    id
    OG005
    title
    IPH2101 1mg/kg
  7. description
    Participants were administered an IV dose of 3mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level.If MTD this is not reached at 3mg/kg, 7 subjects will be enrolled at this dose to obtain more data from a larger subject pool to better evaluate safety, PK, PD and signs of efficacy.
    id
    OG006
    title
    IPH2101 3 mg/kg
param Type
NUMBER
population Description
All treated participants who received at least one dose of the study drug and were evaluable for DLT
reporting Status
POSTED
time Frame
From start of the treatment to end of study
title
Maximum Tolerated Dose (MTD) of IPH2101 as Determined by Number of Participants With Dose-Limiting Toxicities (DLTs) Related to IPH2101 Treatment
type
PRIMARY
unit Of Measure
Number of participants with DLT

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

Preserved source evidence · Not medical advice