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NCT05012397 · OUTCOME

To Determine the ORR of Treatment With Milademetan in Patients With Advanced/Metastatic Solid Tumors With MDM2 Gene Amplification.

Milademetan in Advanced/Metastatic Solid Tumors · Source last updated 2024-10-17

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From first dose date to first confirmed complete or partial response or study completion date; up to 23.5 months.

What was measured

Overall Response Rate (ORR) of treatment with milademetan, as defined as the percentage of patients who have achieved confirmed complete response (CR) or Partial Response (PR) according to RECIST v1.1

Analysis population: This analysis is conducted in all participants within the Centrally confirmed population (CCP) which is defined as all participants who had at least one dose of study treatment and also have WT TP53 and MDM2 amplification with CN ≥ 8 by central testing.

Groups in this outcome

Milademetan (RAIN-32)

260 mg once daily (QD) orally on Days 1 to 3 and Days 15 to 17 of each 28-day cycle

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

Analysis denominator · Participants

GroupSource count
Milademetan (RAIN-32)31

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Milademetan (RAIN-32)3.2Not reported0.116.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.1
        upper Limit
        16.7
        value
        3.2
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    units
    Participants
description
Overall Response Rate (ORR) of treatment with milademetan, as defined as the percentage of patients who have achieved confirmed complete response (CR) or Partial Response (PR) according to RECIST v1.1
dispersion Type
95% Confidence Interval
groups
  1. description
    260 mg once daily (QD) orally on Days 1 to 3 and Days 15 to 17 of each 28-day cycle
    id
    OG000
    title
    Milademetan (RAIN-32)
param Type
NUMBER
population Description
This analysis is conducted in all participants within the Centrally confirmed population (CCP) which is defined as all participants who had at least one dose of study treatment and also have WT TP53 and MDM2 amplification with CN ≥ 8 by central testing.
reporting Status
POSTED
time Frame
From first dose date to first confirmed complete or partial response or study completion date; up to 23.5 months.
title
To Determine the ORR of Treatment With Milademetan in Patients With Advanced/Metastatic Solid Tumors With MDM2 Gene Amplification.
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice