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NCT02757326 · OUTCOME

Maximum Tolerated Dose

ABC294640 (Opaganib) in Refractory / Relapsed Multiple Myeloma · Source last updated 2021-06-18

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

Measure
NUMBER
Unit
mg
Interval / dispersion
Not reported
Time frame
6 months

What was measured

Evaluation of three doses of opaganib - 250 mg bid, 500 mg bid and 750 mg bid to determine the maximum tolerated dose (MTD) based upon the dose limiting toxicity (DLT) using a Bayesian model averaging continual reassessment method and is the dose at which the estimated probability of toxicity is closest to the target probability 0.33 among all doses.

Analysis population: Safety population

Groups in this outcome

Opaganib

Unblinded Phase 1b dose-finding study with dose escalation of study drug ABC294640. Once a subject was determined to be eligible for the study, the subject was enrolled in the dose escalation Phase 1b study testing ABC294640 at 250, 500 and 750 mg twice a day. A cycle of treatment was defined as 28 days and doses were given initially under fasting conditions. Subsequent to a food effect study, treatment was given after a light to moderate meal.

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

Analysis denominator · Participants

GroupSource count
Opaganib13

Reported measurements

Source class 1
Values in mg · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
OpaganibNANot reportedNot reportedNot reportedThe maximum tolerated dose was not reached in the study
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The maximum tolerated dose was not reached in the study
        group Id
        OG000
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    units
    Participants
description
Evaluation of three doses of opaganib - 250 mg bid, 500 mg bid and 750 mg bid to determine the maximum tolerated dose (MTD) based upon the dose limiting toxicity (DLT) using a Bayesian model averaging continual reassessment method and is the dose at which the estimated probability of toxicity is closest to the target probability 0.33 among all doses.
groups
  1. description
    Unblinded Phase 1b dose-finding study with dose escalation of study drug ABC294640. Once a subject was determined to be eligible for the study, the subject was enrolled in the dose escalation Phase 1b study testing ABC294640 at 250, 500 and 750 mg twice a day. A cycle of treatment was defined as 28 days and doses were given initially under fasting conditions. Subsequent to a food effect study, treatment was given after a light to moderate meal.
    id
    OG000
    title
    Opaganib
param Type
NUMBER
population Description
Safety population
reporting Status
POSTED
time Frame
6 months
title
Maximum Tolerated Dose
type
PRIMARY
unit Of Measure
mg

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

Preserved source evidence · Not medical advice