Trial · NCT03395080
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
NCT03395080, Phase 2, Completed, Leap Therapeutics, Inc.; results first posted 2023-06-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT03395080. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03395080
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT03395080
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 111 participants, actual
- Lead sponsor
- Leap Therapeutics, Inc.
- Conditions
- Endometrial Cancer, Uterine Cancer, Ovarian Cancer, Carcinosarcoma
- Interventions
- Paclitaxel, 300mg DKN-01, 600mg DKN-01
- First posted
- 2018-01-10
- Last updated
- 2025-08-01
- Results first posted
- 2023-06-09
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Objective Response Rate (ORR) in EEC or EOC Patients | Baseline to study completion (approximately 6 months) | 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) |
| Primary | Number of Subjects With Objective Response Rate (ORR) in Carcinosarcoma (MMMT) Patients | Baseline to study completion (approximately 6 months) | 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) |
| Secondary | Number of Subjects With Objective Disease Control Rate (ODCR) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT). | Baseline to study completion (approximately 6 months) | 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) |
| Secondary | Overall Survival (OS) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT). | Baseline to study completion (maximum 17.6 months) | Overall Survival (OS) is defined as the time from first dose of study drug until date of death due to any cause. |
| Secondary | Progression-free Survival (PFS) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT). | Baseline to study completion (maximum 7.1 months) | 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. |
| Secondary | Duration of Response (DoR) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT). | Baseline to study completion (approximately 11 months) | 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. |
| Secondary | Duration of Complete Response (DoCR) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT). | Baseline to study completion (approximately 11 months) | Number of participants analyzed only includes patients with a CR and is otherwise defined and analyzed similar to DoR. |
| Secondary | Duration of Clinical Benefit (DoCB) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT). | Baseline to study completion (approximately 13.1 months) | Duration of Clinical Benefit (DoCB) includes patients with a Best Overall Response of CR, PR, or SD and is defined as the time from the first tumor assessment of CR, PR or SD to the time of PD or death due to any cause. |
| Other | Number of Subjects With Response to Therapy in Patients With and Without Activating β-catenin Mutations and/or Wnt Signaling Genetic Alterations in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT) | Baseline to study completion (approximately 6 months) | |
| Other | Dickkopf-1 (DKK1) Concentration in Serum and Plasma Relative to Safety and Efficacy Outcomes in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT). | Baseline to study completion (approximately 6 months) |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Objective Response Rate (ORR) in EEC or EOC Patients | Baseline to study completion (approximately 6 months) | 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. | participants | NUMBER |
| PRIMARY | Number of Subjects With Objective Response Rate (ORR) in Carcinosarcoma (MMMT) Patients | Baseline to study completion (approximately 6 months) | 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. | participants | NUMBER |
| SECONDARY | Number of Subjects With Objective Disease Control Rate (ODCR) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT). | Baseline to study completion (approximately 6 months) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival (OS) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT). | Baseline to study completion (maximum 17.6 months) | Full Analysis Set (FAS), all subjects who received any amount of DKN-01. | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT). | Baseline to study completion (maximum 7.1 months) | Full Analysis Set (FAS), all subjects who received any amount of DKN-01. | months | MEDIAN |
| SECONDARY | Duration of Response (DoR) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT). | Baseline to study completion (approximately 11 months) | Number of participants analyzed only includes the responders in each group. | months | MEDIAN |
| SECONDARY | Duration of Complete Response (DoCR) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT). | Baseline to study completion (approximately 11 months) | Number of participants analyzed only includes patients who have responded with an objective disease response (CR). | months | MEDIAN |
| SECONDARY | Duration of Clinical Benefit (DoCB) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT). | Baseline to study completion (approximately 13.1 months) | Number of participants analyzed only includes patients who had CR, PR, or SD. | months | MEDIAN |
| OTHER_PRE_SPECIFIED | Number of Subjects With Response to Therapy in Patients With and Without Activating β-catenin Mutations and/or Wnt Signaling Genetic Alterations in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT) | Baseline to study completion (approximately 6 months) | |||
| OTHER_PRE_SPECIFIED | Dickkopf-1 (DKK1) Concentration in Serum and Plasma Relative to Safety and Efficacy Outcomes in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT). | Baseline to study completion (approximately 6 months) |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group76
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With Objective Response Rate (ORR) in EEC or EOC Patients | DKN-01 Monotherapy in Recurrent EEC | ORR | 2 | participants | |
| Number of Subjects With Objective Response Rate (ORR) in EEC or EOC Patients | DKN-01 + Paclitaxel in Recurrent EEC | ORR | 0 | participants | |
| Number of Subjects With Objective Response Rate (ORR) in EEC or EOC Patients | DKN-01 Monotherapy in Recurrent EOC | ORR | 0 | participants | |
| Number of Subjects With Objective Response Rate (ORR) in EEC or EOC Patients | DKN-01 + Paclitaxel in Recurrent EOC | ORR | 0 | participants | |
| Number of Subjects With Objective Response Rate (ORR) in EEC or EOC Patients | DKN-01 Monotherapy in Recurrent EEC | Complete Response | 1 | participants | |
| Number of Subjects With Objective Response Rate (ORR) in EEC or EOC Patients | DKN-01 + Paclitaxel in Recurrent EEC | Complete Response | 0 | participants | |
| Number of Subjects With Objective Response Rate (ORR) in EEC or EOC Patients | DKN-01 Monotherapy in Recurrent EOC | Complete Response | 0 | participants | |
| Number of Subjects With Objective Response Rate (ORR) in EEC or EOC Patients | DKN-01 + Paclitaxel in Recurrent EOC | Complete Response | 0 | participants | |
| Number of Subjects With Objective Response Rate (ORR) in EEC or EOC Patients | DKN-01 Monotherapy in Recurrent EEC | Partial Response | 1 | participants | |
| Number of Subjects With Objective Response Rate (ORR) in EEC or EOC Patients | DKN-01 + Paclitaxel in Recurrent EEC | Partial Response | 0 | participants |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | DKN-01 Monotherapy in Recurrent EEC | 29 | |
| Overall Study | STARTED | DKN-01+Paclitaxel in Recurrent EEC | 24 | |
| Overall Study | STARTED | DKN-01 Monotherapy in Recurrent EOC | 14 | |
| Overall Study | STARTED | DKN-01+Paclitaxel in Recurrent EOC | 19 | |
| Overall Study | STARTED | DKN-01 300mg Monotherapy in Carcinosarcoma | 1 | |
| Overall Study | STARTED | DKN-01 600mg Monotherapy in Carcinosarcoma | 8 | |
| Overall Study | STARTED | DKN-01 300mg + Paclitaxel in Carcinosarcoma | 4 | |
| Overall Study | STARTED | DKN-01 600 mg + Paclitaxel in Carcinosarcoma | 12 | |
| Overall Study | COMPLETED | DKN-01 Monotherapy in Recurrent EEC | 26 | |
| Overall Study | COMPLETED | DKN-01+Paclitaxel in Recurrent EEC | 21 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events2,608
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | DKN-01 Monotherapy in Recurrent EEC | 7 | 29 | |
| other | Anaemia | Blood and lymphatic system disorders | DKN-01+Paclitaxel in Recurrent EEC | 13 | 24 | |
| other | Anaemia | Blood and lymphatic system disorders | DKN-01 Monotherapy in Recurrent EOC | 2 | 14 | |
| other | Anaemia | Blood and lymphatic system disorders | DKN-01+Paclitaxel in Recurrent EOC | 3 | 19 | |
| other | Anaemia | Blood and lymphatic system disorders | 300mg DKN-01 Monotherapy in Carcinosarcoma | 0 | 1 | |
| other | Anaemia | Blood and lymphatic system disorders | 600mg DKN-01 Monotherapy in Carcinosarcoma | 0 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | 300mg DKN-01+Paclitaxel in Carcinosarcoma | 0 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | 600mg DKN-01+Paclitaxel in Carcinosarcoma | 4 | 12 | |
| other | Neutropenia | Blood and lymphatic system disorders | DKN-01 Monotherapy in Recurrent EEC | 1 | 29 | |
| other | Neutropenia | Blood and lymphatic system disorders | DKN-01+Paclitaxel in Recurrent EEC | 5 | 24 |
1 to 10 of 2,608Source ClinicalTrials.gov
See all 2,608 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DKN-01 Monotherapy in Recurrent EEC | 14 | 29 |
| Total, all-cause mortality | DKN-01+Paclitaxel in Recurrent EEC | 16 | 24 |
| Total, all-cause mortality | DKN-01 Monotherapy in Recurrent EOC | 11 | 14 |
| Total, all-cause mortality | DKN-01+Paclitaxel in Recurrent EOC | 12 | 19 |
| Total, all-cause mortality | 300mg DKN-01 Monotherapy in Carcinosarcoma | 0 | 1 |
| Total, all-cause mortality | 600mg DKN-01 Monotherapy in Carcinosarcoma | 4 | 8 |
| Total, all-cause mortality | 300mg DKN-01+Paclitaxel in Carcinosarcoma | 2 | 4 |
| Total, all-cause mortality | 600mg DKN-01+Paclitaxel in Carcinosarcoma | 8 | 12 |
| Total, other adverse events | DKN-01 Monotherapy in Recurrent EEC | 29 | 29 |
| Total, other adverse events | DKN-01+Paclitaxel in Recurrent EEC | 24 | 24 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37001446 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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