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NCT05012397 · STUDY IN CONTEXT

Milademetan in Advanced/Metastatic Solid Tumors

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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

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.

→

secondary · POSTED

DOR defined as the time from the date of first documentation of CR or PR according to RECIST v1.1 to the date of disease progression or death due to any cause according to Investigator assessment

This analysis is conducted in all participants within the Centrally confirmed population (CCP) who had a confirmed CR or PR.

→

secondary · POSTED

PFS defined as the time from the date of the first dose of the study drug to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause according to Investigator assessment

The efficacy analysis is conducted in all participants within the Centrally confirmed population (CCP).

→

secondary · POSTED

GMI defined as the ratio of Time to Progression (TTP) with the nth line of therapy (TTPn; here defined as milademetan) to the most recent prior line of therapy (TTPn-1)

The efficacy analysis is conducted in all participants within the Centrally confirmed population (CCP).

→

secondary · POSTED

DCR defined as the percentage of patients with confirmed CR, PR, or stable disease (SD) for ≥ 16 weeks

The efficacy analysis is conducted in all participants within the Centrally confirmed population (CCP).

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer-avgemsi-9fcc56af
nct id
NCT05012397
trial label
Milademetan in Advanced/Metastatic Solid Tumors
applicability
unclear
applicability note
Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
5
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-pancreatic-cancer-avgemsi-9fcc56af
    nct id
    NCT05012397
    outcome key
    om-0000
    source section id
    NCT05012397-om-0000
    source outcome index
    0
    endpoint
    To Determine the ORR of Treatment With Milademetan in Patients With Advanced/Metastatic Solid Tumors With MDM2 Gene Amplification.
    endpoint definition
    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
    time origin
    From first dose date to first confirmed complete or partial response or study completion date; up to 23.5 months.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    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.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-pancreatic-cancer-avgemsi-9fcc56af
    nct id
    NCT05012397
    outcome key
    om-0001
    source section id
    NCT05012397-om-0001
    source outcome index
    1
    endpoint
    Duration of Response (DOR)
    endpoint definition
    DOR defined as the time from the date of first documentation of CR or PR according to RECIST v1.1 to the date of disease progression or death due to any cause according to Investigator assessment
    time origin
    From start date of response to first PD or study completion date; up to 23.5 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    This analysis is conducted in all participants within the Centrally confirmed population (CCP) who had a confirmed CR or PR.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-pancreatic-cancer-avgemsi-9fcc56af
    nct id
    NCT05012397
    outcome key
    om-0002
    source section id
    NCT05012397-om-0002
    source outcome index
    2
    endpoint
    Progression-free Survival (PFS)
    endpoint definition
    PFS defined as the time from the date of the first dose of the study drug to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause according to Investigator assessment
    time origin
    From the first dose date to the earliest date of recurrence, progression, death, or study completion; up to 23.5 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The efficacy analysis is conducted in all participants within the Centrally confirmed population (CCP).
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-pancreatic-cancer-avgemsi-9fcc56af
    nct id
    NCT05012397
    outcome key
    om-0003
    source section id
    NCT05012397-om-0003
    source outcome index
    3
    endpoint
    Growth Modulation Index (GMI)
    endpoint definition
    GMI defined as the ratio of Time to Progression (TTP) with the nth line of therapy (TTPn; here defined as milademetan) to the most recent prior line of therapy (TTPn-1)
    time origin
    From the start date of the most recent prior line of therapy to the PD date on the study; up to 23.5 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The efficacy analysis is conducted in all participants within the Centrally confirmed population (CCP).
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-pancreatic-cancer-avgemsi-9fcc56af
    nct id
    NCT05012397
    outcome key
    om-0004
    source section id
    NCT05012397-om-0004
    source outcome index
    4
    endpoint
    Disease Control Rate (DCR)
    endpoint definition
    DCR defined as the percentage of patients with confirmed CR, PR, or stable disease (SD) for ≥ 16 weeks
    time origin
    From first dose date to first CR, PR, or stable disease (SD) >= 16 weeks, or study completion date; up to 23.5 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The efficacy analysis is conducted in all participants within the Centrally confirmed population (CCP).
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-pancreatic-cancer-avgemsi-9fcc56af
    nct id
    NCT05012397
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Milademetan (RAIN-32)
    regimen
    260 mg once daily (QD) orally on Days 1 to 3 and Days 15 to 17 of each 28-day cycle
    analyzed count
    31
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05012397-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-pancreatic-cancer-avgemsi-9fcc56af
    nct id
    NCT05012397
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Milademetan (RAIN-32)
    regimen
    260 mg once daily (QD) orally on Days 1 to 3 and Days 15 to 17 of each 28-day cycle
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05012397-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-pancreatic-cancer-avgemsi-9fcc56af
    nct id
    NCT05012397
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Milademetan (RAIN-32)
    regimen
    260 mg once daily (QD) orally on Days 1 to 3 and Days 15 to 17 of each 28-day cycle
    analyzed count
    31
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05012397-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-pancreatic-cancer-avgemsi-9fcc56af
    nct id
    NCT05012397
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Milademetan (RAIN-32)
    regimen
    260 mg once daily (QD) orally on Days 1 to 3 and Days 15 to 17 of each 28-day cycle
    analyzed count
    31
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05012397-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-pancreatic-cancer-avgemsi-9fcc56af
    nct id
    NCT05012397
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Milademetan (RAIN-32)
    regimen
    260 mg once daily (QD) orally on Days 1 to 3 and Days 15 to 17 of each 28-day cycle
    analyzed count
    31
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05012397-om-0004#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-pancreatic-cancer-avgemsi-9fcc56af
    nct id
    NCT05012397
    harm key
    EG000
    source section id
    NCT05012397-ae
    event group key
    EG000
    event group label
    Milademetan (RAIN-32)
    serious affected
    11
    serious at risk
    40
    other affected
    40
    other at risk
    40
    frequency threshold
    5
    collection period
    From the first dose date to 30 days after the last dose date or study completion date whichever came first; up to 23.5 months
    event definition
    meets definition
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice