Trial · NCT01846611
A Study Comparing the Combination of Trabectedin (YONDELIS) and DOXIL/CAELYX With DOXIL/CAELYX for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
NCT01846611, Phase 3, Completed, Janssen Research & Development, LLC; results first posted 2019-02-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study Comparing the Combination of Trabectedin (YONDELIS) and DOXIL/CAELYX With DOXIL/CAELYX for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer. Trials, record NCT01846611. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01846611
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Comparing the Combination of Trabectedin (YONDELIS) and DOXIL/CAELYX With DOXIL/CAELYX for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
- NCT number
- NCT01846611
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 581 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Ovarian Neoplasms, Peritoneal Neoplasms, Fallopian Tube Neoplasms
- Interventions
- Trabectedin, DOXIL, Dexamethasone, DOXIL
- First posted
- 2013-05-03
- Last updated
- 2019-04-01
- Other registries' IDs
- eudract:2012-004808-34
- Results first posted
- 2019-02-06
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | Up to 4.3 years | OS is defined as the time between the date of randomization and the date of death. Participants who died, regardless of the cause of death, were considered to have had an event. |
| Secondary | Progression-Free Survival (PFS) | Up to 4.3 years | PFS is defined as the time between the date of randomization and the date of disease progression or death. PFS was assessed using the response evaluation criteria in solid tumors (RECIST) Version 1.1. As per criteria progressive disease in case of target lesions means at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). Progressive disease in case of non-target lesions means unequivocal progression of existing non-target lesions. In both cases the appearance of one or more new lesions is also considered progression. |
| Secondary | Objective Response Rate (ORR) | Up to 4.3 years | ORR is defined as the percentage of participants with measurable disease achieving a best overall response of either complete response (CR) or partial response (PR) based on RECIST. CR: disappearance of all target and non-target lesions and normalization of tumor marker levels in non-target lesions. PR: at least a 30 percent (%) decrease in the sum of longest diameter (LD) of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | Up to 4.3 years | All randomized analysis set included all participants who were randomized to study treatment independent of whether they received study drug. | months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) | Up to 4.3 years | All randomized analysis set included all participants who were randomized to study treatment independent of whether they received study drug. | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) | Up to 4.3 years | All randomized analysis set included all participants who were randomized to study treatment independent of whether they received study drug. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Trabectedin + DOXIL | 23.82 | 95% Confidence Interval 20.30 to 26.12 | months | |
| Overall Survival (OS) | DOXIL | 22.21 | 95% Confidence Interval 18.10 to 24.67 | months | |
| Progression-Free Survival (PFS) | Trabectedin + DOXIL | 7.52 | 95% Confidence Interval 6.93 to 9.43 | months | |
| Progression-Free Survival (PFS) | DOXIL | 7.26 | 95% Confidence Interval 6.14 to 7.59 | months | |
| Objective Response Rate (ORR) | Trabectedin + DOXIL | 46.0 | 95% Confidence Interval 40.2 to 52.0 | Percentage of participants | |
| Objective Response Rate (ORR) | DOXIL | 35.9 | 95% Confidence Interval 30.3 to 41.7 | Percentage of participants |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Trabectedin + DOXIL | 289 | |
| Overall Study | STARTED | DOXIL | 287 | |
| Overall Study | Treated | Trabectedin + DOXIL | 286 | |
| Overall Study | Treated | DOXIL | 282 | |
| Overall Study | COMPLETED | Trabectedin + DOXIL | 251 | |
| Overall Study | COMPLETED | DOXIL | 244 | |
| Overall Study | NOT COMPLETED | Trabectedin + DOXIL | 38 | |
| Overall Study | NOT COMPLETED | DOXIL | 43 |
Source ClinicalTrials.gov
Adverse events474
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 | Trabectedin + DOXIL | 135 | 286 | |
| other | Anaemia | Blood and lymphatic system disorders | DOXIL | 70 | 282 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Trabectedin + DOXIL | 9 | 286 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | DOXIL | 2 | 282 | |
| other | Leukopenia | Blood and lymphatic system disorders | Trabectedin + DOXIL | 53 | 286 | |
| other | Leukopenia | Blood and lymphatic system disorders | DOXIL | 38 | 282 | |
| other | Neutropenia | Blood and lymphatic system disorders | Trabectedin + DOXIL | 149 | 286 | |
| other | Neutropenia | Blood and lymphatic system disorders | DOXIL | 104 | 282 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Trabectedin + DOXIL | 63 | 286 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | DOXIL | 18 | 282 |
1 to 10 of 474Source ClinicalTrials.gov
See all 474 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Trabectedin + DOXIL | 132 | 286 |
| Total, all-cause mortality | DOXIL | 131 | 282 |
| Total, other adverse events | Trabectedin + DOXIL | 282 | 286 |
| Total, other adverse events | DOXIL | 273 | 282 |
| Total, serious adverse events | Trabectedin + DOXIL | 118 | 286 |
| Total, serious adverse events | DOXIL | 58 | 282 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Trabectedin + DOXIL vs DOXIL: deaths from any cause | Trial comparisons |
| Trabectedin + DOXIL vs DOXIL: serious adverse events | Trial comparisons |
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.
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/NCT01846611
GET https://conductscience.org/api/trials/v1/NCT01846611/events?page=2