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.

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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.

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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).

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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).

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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).

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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-cervical-cancer-jobevne-5a0678d2
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

release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-jobevne-5a0678d2
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
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-jobevne-5a0678d2
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
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-jobevne-5a0678d2
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
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-jobevne-5a0678d2
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
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-jobevne-5a0678d2
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

release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-jobevne-5a0678d2
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
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-jobevne-5a0678d2
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
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-jobevne-5a0678d2
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
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-jobevne-5a0678d2
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
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-jobevne-5a0678d2
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

release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-jobevne-5a0678d2
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