NCT03395080 · STUDY IN CONTEXT

A Study of DKN-01 as a Monotherapy or in Combination With Paclitaxel in Patients With Recurrent Epithelial Endometrial or Epithelial Ovarian Cancer or Carcinosarcoma

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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

Best overall response of Complete Response (CR; disappearance of all target lesions, any pathological lymph nodes whether target or non-target must have reduction in short axis to \<10mm) or Partial Response (PR; at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1)

Evaluable Analysis Set (EAS), all subjects who received any amount of DKN-01 and had at least 1 evaluated post-baseline RECIST assessment or were discontinued due to death.

→

primary · POSTED

Best overall response of Complete Response (CR; disappearance of all target lesions, any pathological lymph nodes whether target or non-target must have reduction in short axis to \<10mm) or Partial Response (PR; at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1)

Evaluable Analysis Set, all subjects who received any amount of DKN-01 and had at least 1 evaluated post-baseline RECIST assessment or were discontinued due to death.

→

secondary · POSTED

Objective Disease Control Rate (ODCR) was defined as the percentage of subjects with a Best Overall Response of Complete Response (CR; disappearance of all target lesions, any pathological lymph nodes whether target or non-target must have reduction in short axis to \<10mm), Partial Response (PR; at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters), or Stable Disease (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as Progressive Disease) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1)

Evaluable Analysis Set (EAS), all subjects who received any amount of DKN-01 and had at least 1 evaluated post-baseline RECIST assessment or were discontinued due to death.

→

secondary · POSTED

Overall Survival (OS) is defined as the time from first dose of study drug until date of death due to any cause.

Full Analysis Set (FAS), all subjects who received any amount of DKN-01.

→

secondary · POSTED

Progression-free survival (PFS) is defined as time from first dose of study drug to first documentation of PD (per RECIST 1.1) or death due to any cause.

Full Analysis Set (FAS), all subjects who received any amount of DKN-01.

→

secondary · POSTED

Duration of Response (DoR) includes only patients that have responded with an objective disease response (PR or CR) and is defined as the time from the first tumor assessment that supports the patient's objective disease response to the time of PD or death due to any cause.

Number of participants analyzed only includes the responders in each group.

→

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-malignant-uterine-neoplasm
nct id: NCT03395080
trial label: A Study of DKN-01 as a Monotherapy or in Combination With Paclitaxel in Patients With Recurrent Epithelial Endometrial or Epithelial Ovarian Cancer or Carcinosarcoma
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
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: 6
harms Count: 8
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-malignant-uterine-neoplasm
nct id
NCT03395080
outcome key
om-0000
source section id
NCT03395080-om-0000
source outcome index
0
endpoint
Number of Subjects With Objective Response Rate (ORR) in EEC or EOC Patients
endpoint definition
Best overall response of Complete Response (CR; disappearance of all target lesions, any pathological lymph nodes whether target or non-target must have reduction in short axis to \<10mm) or Partial Response (PR; at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1)
time origin
Baseline to study completion (approximately 6 months)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Evaluable Analysis Set (EAS), all subjects who received any amount of DKN-01 and had at least 1 evaluated post-baseline RECIST assessment or were discontinued due to death.
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-malignant-uterine-neoplasm
nct id
NCT03395080
outcome key
om-0001
source section id
NCT03395080-om-0001
source outcome index
1
endpoint
Number of Subjects With Objective Response Rate (ORR) in Carcinosarcoma (MMMT) Patients
endpoint definition
Best overall response of Complete Response (CR; disappearance of all target lesions, any pathological lymph nodes whether target or non-target must have reduction in short axis to \<10mm) or Partial Response (PR; at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1)
time origin
Baseline to study completion (approximately 6 months)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Evaluable Analysis Set, all subjects who received any amount of DKN-01 and had at least 1 evaluated post-baseline RECIST assessment or were discontinued due to death.
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-malignant-uterine-neoplasm
nct id
NCT03395080
outcome key
om-0002
source section id
NCT03395080-om-0002
source outcome index
2
endpoint
Number of Subjects With Objective Disease Control Rate (ODCR) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
endpoint definition
Objective Disease Control Rate (ODCR) was defined as the percentage of subjects with a Best Overall Response of Complete Response (CR; disappearance of all target lesions, any pathological lymph nodes whether target or non-target must have reduction in short axis to \<10mm), Partial Response (PR; at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters), or Stable Disease (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as Progressive Disease) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1)
time origin
Baseline to study completion (approximately 6 months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Evaluable Analysis Set (EAS), all subjects who received any amount of DKN-01 and had at least 1 evaluated post-baseline RECIST assessment or were discontinued due to death.
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-malignant-uterine-neoplasm
nct id
NCT03395080
outcome key
om-0003
source section id
NCT03395080-om-0003
source outcome index
3
endpoint
Overall Survival (OS) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
endpoint definition
Overall Survival (OS) is defined as the time from first dose of study drug until date of death due to any cause.
time origin
Baseline to study completion (maximum 17.6 months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Full Analysis Set (FAS), all subjects who received any amount of DKN-01.
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-malignant-uterine-neoplasm
nct id
NCT03395080
outcome key
om-0004
source section id
NCT03395080-om-0004
source outcome index
4
endpoint
Progression-free Survival (PFS) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
endpoint definition
Progression-free survival (PFS) is defined as time from first dose of study drug to first documentation of PD (per RECIST 1.1) or death due to any cause.
time origin
Baseline to study completion (maximum 7.1 months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Full Analysis Set (FAS), all subjects who received any amount of DKN-01.
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-malignant-uterine-neoplasm
nct id
NCT03395080
outcome key
om-0005
source section id
NCT03395080-om-0005
source outcome index
5
endpoint
Duration of Response (DoR) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
endpoint definition
Duration of Response (DoR) includes only patients that have responded with an objective disease response (PR or CR) and is defined as the time from the first tumor assessment that supports the patient's objective disease response to the time of PD or death due to any cause.
time origin
Baseline to study completion (approximately 11 months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Number of participants analyzed only includes the responders in each group.
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-malignant-uterine-neoplasm
nct id
NCT03395080
outcome key
om-0000
arm key
OG000
arm label
DKN-01 Monotherapy in Recurrent EEC
regimen
300mg DKN-01 monotherapy in recurrent EEC. DKN-01 administered by IV infusion.
analyzed count
26
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03395080-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-uterine-neoplasm
nct id
NCT03395080
outcome key
om-0000
arm key
OG001
arm label
DKN-01 + Paclitaxel in Recurrent EEC
regimen
300mg DKN-01+paclitaxel in recurrent EEC. DKN-01 and paclitaxel administered by IV infusion.
analyzed count
21
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03395080-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-malignant-uterine-neoplasm
nct id
NCT03395080
outcome key
om-0000
arm key
OG002
arm label
DKN-01 Monotherapy in Recurrent EOC
regimen
300mg DKN-01 monotherapy in recurrent EOC. DKN-01 administered by IV infusion.
analyzed count
13
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03395080-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-malignant-uterine-neoplasm
nct id
NCT03395080
outcome key
om-0000
arm key
OG003
arm label
DKN-01 + Paclitaxel in Recurrent EOC
regimen
300mg DKN-01+paclitaxel in recurrent EOC. DKN-01 and paclitaxel administered by IV infusion.
analyzed count
19
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03395080-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-malignant-uterine-neoplasm
nct id
NCT03395080
outcome key
om-0001
arm key
OG000
arm label
DKN-01 300mg Monotherapy in Carcinosarcoma
regimen
300mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03395080-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-uterine-neoplasm
nct id
NCT03395080
outcome key
om-0001
arm key
OG001
arm label
DKN-01 600mg Monotherapy in Carcinosarcoma
regimen
600mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03395080-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-malignant-uterine-neoplasm
nct id
NCT03395080
outcome key
om-0001
arm key
OG002
arm label
DKN-01 300mg + Paclitaxel in Carcinosarcoma
regimen
300mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03395080-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-malignant-uterine-neoplasm
nct id
NCT03395080
outcome key
om-0001
arm key
OG003
arm label
DKN-01 600mg + Paclitaxel in Carcinosarcoma
regimen
600mg DKN-01 + paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03395080-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-malignant-uterine-neoplasm
nct id
NCT03395080
outcome key
om-0002
arm key
OG000
arm label
DKN-01 Monotherapy in Recurrent EEC
regimen
300mg DKN-01 monotherapy in recurrent EEC. DKN-01 administered by IV infusion.
analyzed count
26
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03395080-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-uterine-neoplasm
nct id
NCT03395080
outcome key
om-0002
arm key
OG001
arm label
DKN-01 + Paclitaxel in Recurrent EEC
regimen
300mg DKN-01+paclitaxel in recurrent EEC. DKN-01 and paclitaxel administered by IV infusion.
analyzed count
21
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03395080-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-malignant-uterine-neoplasm
nct id
NCT03395080
outcome key
om-0002
arm key
OG002
arm label
DKN-01 Monotherapy in Recurrent EOC
regimen
300mg DKN-01 monotherapy in recurrent EOC. DKN-01 administered by IV infusion.
analyzed count
13
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03395080-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-malignant-uterine-neoplasm
nct id
NCT03395080
outcome key
om-0002
arm key
OG003
arm label
DKN-01 + Paclitaxel in Recurrent EOC
regimen
300mg DKN-01+paclitaxel in recurrent EOC. DKN-01 and paclitaxel administered by IV infusion.
analyzed count
19
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03395080-om-0002#groups/OG003

harms

release id
clinical-indications-draft-1
disease state id
ds-malignant-uterine-neoplasm
nct id
NCT03395080
harm key
EG000
source section id
NCT03395080-ae
event group key
EG000
event group label
DKN-01 Monotherapy in Recurrent EEC
serious affected
8
serious at risk
29
other affected
29
other at risk
29
frequency threshold
0
collection period
The Safety Analysis Set is all subjects who received greater than or equal to 1 administration of assigned study treatment (DKN-01 or paclitaxel). Subjects were followed for treatment emergent adverse events (AE), defined as any AE with an onset or worsening of a pre-existing condition on or after the first dose of the study drug through 30 days following the last dose of study drug, up to approximately 2 years.
event definition
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment and within 30 days after the last study treatment dose.
undenominated note
Source null
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-malignant-uterine-neoplasm
nct id
NCT03395080
harm key
EG001
source section id
NCT03395080-ae
event group key
EG001
event group label
DKN-01+Paclitaxel in Recurrent EEC
serious affected
13
serious at risk
24
other affected
24
other at risk
24
frequency threshold
0
collection period
The Safety Analysis Set is all subjects who received greater than or equal to 1 administration of assigned study treatment (DKN-01 or paclitaxel). Subjects were followed for treatment emergent adverse events (AE), defined as any AE with an onset or worsening of a pre-existing condition on or after the first dose of the study drug through 30 days following the last dose of study drug, up to approximately 2 years.
event definition
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment and within 30 days after the last study treatment dose.
undenominated note
Source null
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-malignant-uterine-neoplasm
nct id
NCT03395080
harm key
EG002
source section id
NCT03395080-ae
event group key
EG002
event group label
DKN-01 Monotherapy in Recurrent EOC
serious affected
1
serious at risk
14
other affected
13
other at risk
14
frequency threshold
0
collection period
The Safety Analysis Set is all subjects who received greater than or equal to 1 administration of assigned study treatment (DKN-01 or paclitaxel). Subjects were followed for treatment emergent adverse events (AE), defined as any AE with an onset or worsening of a pre-existing condition on or after the first dose of the study drug through 30 days following the last dose of study drug, up to approximately 2 years.
event definition
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment and within 30 days after the last study treatment dose.
undenominated note
Source null
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-malignant-uterine-neoplasm
nct id
NCT03395080
harm key
EG003
source section id
NCT03395080-ae
event group key
EG003
event group label
DKN-01+Paclitaxel in Recurrent EOC
serious affected
6
serious at risk
19
other affected
19
other at risk
19
frequency threshold
0
collection period
The Safety Analysis Set is all subjects who received greater than or equal to 1 administration of assigned study treatment (DKN-01 or paclitaxel). Subjects were followed for treatment emergent adverse events (AE), defined as any AE with an onset or worsening of a pre-existing condition on or after the first dose of the study drug through 30 days following the last dose of study drug, up to approximately 2 years.
event definition
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment and within 30 days after the last study treatment dose.
undenominated note
Source null
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-malignant-uterine-neoplasm
nct id
NCT03395080
harm key
EG004
source section id
NCT03395080-ae
event group key
EG004
event group label
300mg DKN-01 Monotherapy in Carcinosarcoma
serious affected
1
serious at risk
1
other affected
1
other at risk
1
frequency threshold
0
collection period
The Safety Analysis Set is all subjects who received greater than or equal to 1 administration of assigned study treatment (DKN-01 or paclitaxel). Subjects were followed for treatment emergent adverse events (AE), defined as any AE with an onset or worsening of a pre-existing condition on or after the first dose of the study drug through 30 days following the last dose of study drug, up to approximately 2 years.
event definition
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment and within 30 days after the last study treatment dose.
undenominated note
Source null
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-malignant-uterine-neoplasm
nct id
NCT03395080
harm key
EG005
source section id
NCT03395080-ae
event group key
EG005
event group label
600mg DKN-01 Monotherapy in Carcinosarcoma
serious affected
2
serious at risk
8
other affected
8
other at risk
8
frequency threshold
0
collection period
The Safety Analysis Set is all subjects who received greater than or equal to 1 administration of assigned study treatment (DKN-01 or paclitaxel). Subjects were followed for treatment emergent adverse events (AE), defined as any AE with an onset or worsening of a pre-existing condition on or after the first dose of the study drug through 30 days following the last dose of study drug, up to approximately 2 years.
event definition
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment and within 30 days after the last study treatment dose.
undenominated note
Source null
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-malignant-uterine-neoplasm
nct id
NCT03395080
harm key
EG006
source section id
NCT03395080-ae
event group key
EG006
event group label
300mg DKN-01+Paclitaxel in Carcinosarcoma
serious affected
0
serious at risk
4
other affected
4
other at risk
4
frequency threshold
0
collection period
The Safety Analysis Set is all subjects who received greater than or equal to 1 administration of assigned study treatment (DKN-01 or paclitaxel). Subjects were followed for treatment emergent adverse events (AE), defined as any AE with an onset or worsening of a pre-existing condition on or after the first dose of the study drug through 30 days following the last dose of study drug, up to approximately 2 years.
event definition
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment and within 30 days after the last study treatment dose.
undenominated note
Source null
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-malignant-uterine-neoplasm
nct id
NCT03395080
harm key
EG007
source section id
NCT03395080-ae
event group key
EG007
event group label
600mg DKN-01+Paclitaxel in Carcinosarcoma
serious affected
6
serious at risk
12
other affected
12
other at risk
12
frequency threshold
0
collection period
The Safety Analysis Set is all subjects who received greater than or equal to 1 administration of assigned study treatment (DKN-01 or paclitaxel). Subjects were followed for treatment emergent adverse events (AE), defined as any AE with an onset or worsening of a pre-existing condition on or after the first dose of the study drug through 30 days following the last dose of study drug, up to approximately 2 years.
event definition
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment and within 30 days after the last study treatment dose.
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