Trial · NCT03783949
European Trial on Enhanced DNA Repair Inhibition in Ovarian Cancer
NCT03783949, Phase 2, Completed, Universitaire Ziekenhuizen KU Leuven; results first posted 2025-06-11
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. European Trial on Enhanced DNA Repair Inhibition in Ovarian Cancer. Trials, record NCT03783949. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03783949
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- European Trial on Enhanced DNA Repair Inhibition in Ovarian Cancer
- NCT number
- NCT03783949
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 122 participants, actual
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
- Interventions
- Ganetespib, Niraparib, Carboplatin, Paclitaxel, Gemcitabine
- First posted
- 2018-12-21
- Last updated
- 2025-06-11
- Results first posted
- 2025-06-11
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival | 3 years 10 months | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions |
| Secondary | Progression-free Survival in BRCA Mutated Patients | 3 years 10 months | Progression-free survival analysis in BRCA mutated patients |
| Secondary | Post-progression PFS (PFS2) | 3 years 10 months | Post-progression PFS (PFS2) analysis |
| Secondary | Time to First Subsequent Therapy (TFST) | 3 years 10 months | Time to First Subsequent Therapy (TFST) analysis |
| Secondary | Time to Second Subsequent Therapy (TSST) | 3 years 10 months | Time to Second Subsequent Therapy (TSST) analysis |
| Secondary | Progression-free Survival in Patients Without BRCA Mutation or With Unknown BRCA Status | 3 years 10 months | Progression-free Survival analysis in Patients without BRCA mutation or with unknown BRCA status |
| Secondary | Objective Response Rate (ORR) | 3 years 10 months | Objective response rate (ORR) analysis |
| Secondary | Overall Survival (OS) | 3 years 10 months | Overall survival (OS) analysis |
| Secondary | Progression-free Survival in Patients With Prior PARPi Treatment | 3 years 10 months | Progression-free Survival analysis in Patients with prior PARPi treatment |
| Secondary | Progression-free Survival in Patients With One Prior Line of Therapy | 3 years 10 months | Progression-free Survival analysis in Patients with one prior line of therapy |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival | 3 years 10 months | The primary aim of this study was to determine the efficacy of the new agent regarding progression-free survival (PFS). Therefore the main analysis, as foreseen in the protocol, combined the two study arms with Ganetespib (arms B and C) and compare it against the standard arm (arm A). | months | MEDIAN |
| SECONDARY | Progression-free Survival in BRCA Mutated Patients | 3 years 10 months | The primary aim of this study was to determine the efficacy of the new agent regarding progression-free survival (PFS). Therefore the main analysis, as foreseen in the protocol, combined the two study arms with Ganetespib (arms B and C) and compare it against the standard arm (arm A), both for the primary outcome as for all secondary and exploratory outcomes. | months | MEAN |
| SECONDARY | Post-progression PFS (PFS2) | 3 years 10 months | The primary aim of this study was to determine the efficacy of the new agent regarding progression-free survival (PFS). Therefore the main analysis, as foreseen in the protocol, combined the two study arms with Ganetespib (arms B and C) and compare it against the standard arm (arm A), both for the primary outcome as for all secondary and exploratory outcomes. | months | MEDIAN |
| SECONDARY | Time to First Subsequent Therapy (TFST) | 3 years 10 months | The primary aim of this study was to determine the efficacy of the new agent regarding progression-free survival (PFS). Therefore the main analysis, as foreseen in the protocol, combined the two study arms with Ganetespib (arms B and C) and compare it against the standard arm (arm A), both for the primary outcome as for all secondary and exploratory outcomes. | months | MEDIAN |
| SECONDARY | Time to Second Subsequent Therapy (TSST) | 3 years 10 months | The primary aim of this study was to determine the efficacy of the new agent regarding progression-free survival (PFS). Therefore the main analysis, as foreseen in the protocol, combined the two study arms with Ganetespib (arms B and C) and compare it against the standard arm (arm A), both for the primary outcome as for all secondary and exploratory outcomes. | months | MEDIAN |
| SECONDARY | Progression-free Survival in Patients Without BRCA Mutation or With Unknown BRCA Status | 3 years 10 months | The primary aim of this study was to determine the efficacy of the new agent regarding progression-free survival (PFS). Therefore the main analysis, as foreseen in the protocol, combined the two study arms with Ganetespib (arms B and C) and compare it against the standard arm (arm A), both for the primary outcome as for all secondary and exploratory outcomes. | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) | 3 years 10 months | The primary aim of this study was to determine the efficacy of the new agent regarding progression-free survival (PFS). Therefore the main analysis, as foreseen in the protocol, combined the two study arms with Ganetespib (arms B and C) and compare it against the standard arm (arm A), both for the primary outcome as for all secondary and exploratory outcomes. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival (OS) | 3 years 10 months | The primary aim of this study was to determine the efficacy of the new agent regarding progression-free survival (PFS). Therefore the main analysis, as foreseen in the protocol, combined the two study arms with Ganetespib (arms B and C) and compare it against the standard arm (arm A), both for the primary outcome as for all secondary and exploratory outcomes. | months | MEDIAN |
| SECONDARY | Progression-free Survival in Patients With Prior PARPi Treatment | 3 years 10 months | The primary aim of this study was to determine the efficacy of the new agent regarding progression-free survival (PFS). Therefore the main analysis, as foreseen in the protocol, combined the two study arms with Ganetespib (arms B and C) and compare it against the standard arm (arm A), both for the primary outcome as for all secondary and exploratory outcomes. | months | MEDIAN |
| SECONDARY | Progression-free Survival in Patients With One Prior Line of Therapy | 3 years 10 months | The primary aim of this study was to determine the efficacy of the new agent regarding progression-free survival (PFS). Therefore the main analysis, as foreseen in the protocol, combined the two study arms with Ganetespib (arms B and C) and compare it against the standard arm (arm A), both for the primary outcome as for all secondary and exploratory outcomes. | months | MEDIAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival | Standard Arm (Arm A) | 8.85 | 95% Confidence Interval 7.73 to 11.55 | months | |
| Progression-free Survival | Experimental Arms (Arm B&C) | 8.32 | 95% Confidence Interval 6.88 to 9.70 | months | |
| Progression-free Survival in BRCA Mutated Patients | Standard Arm (Arm A) | 11.78 | 95% Confidence Interval 7.30 to 17.37 | months | |
| Progression-free Survival in BRCA Mutated Patients | Experimental Arms (Arm B&C) | 7.98 | 95% Confidence Interval 6.09 to 11.05 | months | |
| Post-progression PFS (PFS2) | Standard Arm (Arm A) | 21.71 | 95% Confidence Interval 17.73 to 25.30 | months | |
| Post-progression PFS (PFS2) | Experimental Arms (Arm B&C) | 21.38 | 95% Confidence Interval 15.53 to 26.18 | months | |
| Time to First Subsequent Therapy (TFST) | Standard Arm (Arm A) | 9.38 | 95% Confidence Interval 8.09 to 12.47 | months | |
| Time to First Subsequent Therapy (TFST) | Experimental Arms (Arm B&C) | 8.75 | 95% Confidence Interval 7.40 to 10.07 | months | |
| Time to Second Subsequent Therapy (TSST) | Standard Arm (Arm A) | 17.73 | 95% Confidence Interval 14.28 to 21.61 | months | |
| Time to Second Subsequent Therapy (TSST) | Experimental Arms (Arm B&C) | 14.54 | 95% Confidence Interval 13.26 to 16.94 | months |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Standard Arm (Arm A) | 41 | |
| Overall Study | STARTED | First Experimental Arm (Arm B) | 42 | |
| Overall Study | STARTED | Second Experimental Arm (Arm C) | 39 | |
| Overall Study | COMPLETED | Standard Arm (Arm A) | 2 | |
| Overall Study | COMPLETED | First Experimental Arm (Arm B) | 0 | |
| Overall Study | COMPLETED | Second Experimental Arm (Arm C) | 2 | |
| Overall Study | NOT COMPLETED | Standard Arm (Arm A) | 39 | |
| Overall Study | NOT COMPLETED | First Experimental Arm (Arm B) | 42 | |
| Overall Study | NOT COMPLETED | Second Experimental Arm (Arm C) | 37 |
Source ClinicalTrials.gov
Adverse events558
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 | QTc prolongation | Cardiac disorders | Standard Arm (Arm A) - Chemotherapy Phase | 0 | 41 | 0 |
| other | QTc prolongation | Cardiac disorders | First Experimental Arm (Arm B) - Chemotherapy Phase | 3 | 42 | 3 |
| other | QTc prolongation | Cardiac disorders | Second Experimental Arm (Arm C) - Chemotherapy Phase | 0 | 39 | 0 |
| other | QTc prolongation | Cardiac disorders | Standard Arm (Arm A) - Maintenance Phase | 0 | 32 | 0 |
| other | QTc prolongation | Cardiac disorders | First Experimental Arm (Arm B) - Maintenance Phase | 0 | 26 | 0 |
| other | QTc prolongation | Cardiac disorders | Second Experimental Arm (Arm C) - Maintenance Phase | 0 | 17 | 0 |
| other | abdominal cramping | General disorders | Standard Arm (Arm A) - Chemotherapy Phase | 3 | 41 | 3 |
| other | abdominal cramping | General disorders | First Experimental Arm (Arm B) - Chemotherapy Phase | 0 | 42 | 0 |
| other | abdominal cramping | General disorders | Second Experimental Arm (Arm C) - Chemotherapy Phase | 1 | 39 | 1 |
| other | abdominal cramping | General disorders | Standard Arm (Arm A) - Maintenance Phase | 0 | 32 | 0 |
1 to 10 of 558Source ClinicalTrials.gov
See all 558 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Standard Arm (Arm A) - Chemotherapy Phase | 41 | 41 |
| Total, all-cause mortality | First Experimental Arm (Arm B) - Chemotherapy Phase | 42 | 42 |
| Total, all-cause mortality | Second Experimental Arm (Arm C) - Chemotherapy Phase | 39 | 39 |
| Total, all-cause mortality | Standard Arm (Arm A) - Maintenance Phase | 32 | 32 |
| Total, all-cause mortality | First Experimental Arm (Arm B) - Maintenance Phase | 26 | 26 |
| Total, all-cause mortality | Second Experimental Arm (Arm C) - Maintenance Phase | 17 | 17 |
| Total, other adverse events | Standard Arm (Arm A) - Chemotherapy Phase | 40 | 41 |
| Total, other adverse events | First Experimental Arm (Arm B) - Chemotherapy Phase | 42 | 42 |
| Total, other adverse events | Second Experimental Arm (Arm C) - Chemotherapy Phase | 39 | 39 |
| Total, other adverse events | Standard Arm (Arm A) - Maintenance Phase | 32 | 32 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03783949
GET https://conductscience.org/api/trials/v1/NCT03783949/results?page=2