Trial · NCT00113607
An Efficacy and Safety Study for Yondelis (Trabectedin) in Patients With Advanced Relapsed Ovarian Cancer
NCT00113607, Phase 3, Completed, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; results first posted 2013-08-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Efficacy and Safety Study for Yondelis (Trabectedin) in Patients With Advanced Relapsed Ovarian Cancer. Trials, record NCT00113607. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00113607
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Efficacy and Safety Study for Yondelis (Trabectedin) in Patients With Advanced Relapsed Ovarian Cancer
- NCT number
- NCT00113607
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 672 participants, actual
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Conditions
- Ovarian Cancer
- Interventions
- Trabectedin, DOXIL, Dexamethasone
- First posted
- 2005-06-10
- Last updated
- 2014-06-27
- Other registries' IDs
- eudract:2004-005276-16
- Results first posted
- 2013-08-23
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS): Independent Radiologist Review | From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years | PFS is defined as the time between randomization and disease progression or death. |
| Secondary | Overall Survival | From the date of randomization until the date of death, as assessed for approximately 3 years | Overall survival was defined as the time between the randomization and death |
| Secondary | Objective Response Rate (ORR) - Independent Radiologist Review | From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years | Percentage of participants who achieved complete response (CR) or partial response (PR) as best overall response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR)= greater than or equal to 30% decrease in the sum of the longest diameter of target lesions and Overall Response (OR) = CR + PR. |
| Secondary | Duration of Response: Independent Radiologist Review | From the date of first documentation of response to the date of disease progression or death due to progressive disease, as assessed for approximately 3 years | Duration of response was defined only for participants who had complete response or partial response as best overall response. Duration of response was calculated from the date of first documentation of response (not the confirmation) to the date of disease progression or death due to progressive disease. |
| Secondary | Median Area Under Curve (AUC) of Trabectedin. | Day 1 (Predose; 1.5 hour after start of infusion; 5 minutes, 2 hour and 6 to 20 hour after end of infusion); Day 8 (168 hour after end of infusion); and Day 15 (336 hour after end of infusion) at Cycles 1 and 2 | Median simulated area under the curve (AUC) of a 21 day trabectedin profile of participants (of this study) administering trabectedin and doxil, calculated using the trapezoidal rule method. Simulations were based on a dataset created of 1000 participants using the posthoc parameter estimations, derived from the population pharmacokinetic analysis dataset of Trabectedin (Participants=831, with resampling). Plasma concentration-time profiles were simulated up to 504 hour post-dosing using a rich sampling. |
| Secondary | Median Maximum Plasma Concentration (Cmax) of Trabectedin. | Day 1 (Predose; 1.5 hour after start of infusion; 5 minutes, 2 hour and 6 to 20 hour after end of infusion); Day 8 (168 hour after end of infusion); and Day 15 (336 hour after end of infusion) at Cycles 1 and 2 | Median simulated maximum plasma concentration (Cmax) at 3 hour of a 21 day trabectedin profile of participants (of this study) administering trabectedin and doxil. The assessment of Cmax was based on a dataset created of 1000 participants using the posthoc parameter estimations, derived from the population pharmacokinetic analysis dataset of Trabectedin (participants=831, with resampling). Plasma concentration-time profiles were simulated up to 504 hour post-dosing using a rich sampling. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS): Independent Radiologist Review | From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years | All Measurable Analysis Participants: All randomized participants who had measurable disease at baseline as assessed by the independent radiology review. Measurable disease is defined as having at least 1 lesion measured with a diameter of ≥20 mm using conventional techniques or of ≥10 mm using a spiral computerized tomography scan. | Months | MEDIAN |
| SECONDARY | Overall Survival | From the date of randomization until the date of death, as assessed for approximately 3 years | All Randomized Analysis Participants: all participants who were randomized to this study, independent of whether they received study medication or not | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) - Independent Radiologist Review | From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years | All Randomized Analysis Participants: all participants who were randomized to this study, independent of whether they received study medication or not. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response: Independent Radiologist Review | From the date of first documentation of response to the date of disease progression or death due to progressive disease, as assessed for approximately 3 years | All Responders (CR/PR) Analysis Participants: all participants who achieved CR or PR as best overall response during the study. | Months | MEDIAN |
| SECONDARY | Median Area Under Curve (AUC) of Trabectedin. | Day 1 (Predose; 1.5 hour after start of infusion; 5 minutes, 2 hour and 6 to 20 hour after end of infusion); Day 8 (168 hour after end of infusion); and Day 15 (336 hour after end of infusion) at Cycles 1 and 2 | Blood samples for pharmacokinetic analysis were collected from 86 participants of this study. | ng*h/mL | NUMBER |
| SECONDARY | Median Maximum Plasma Concentration (Cmax) of Trabectedin. | Day 1 (Predose; 1.5 hour after start of infusion; 5 minutes, 2 hour and 6 to 20 hour after end of infusion); Day 8 (168 hour after end of infusion); and Day 15 (336 hour after end of infusion) at Cycles 1 and 2 | Blood samples for pharmacokinetic analysis were collected from 86 participants of this study. | pg/mL | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS): Independent Radiologist Review | DOXIL | 5.8 | 95% Confidence Interval 5.5 to 7.1 | Months | |
| Progression-Free Survival (PFS): Independent Radiologist Review | Trabectedin/DOXIL | 7.3 | 95% Confidence Interval 5.9 to 7.9 | Months | |
| Overall Survival | DOXIL | 18.9 | 95% Confidence Interval 17.1 to 21.5 | Months | |
| Overall Survival | Trabectedin/DOXIL | 22.2 | 95% Confidence Interval 19.3 to 25.0 | Months | |
| Objective Response Rate (ORR) - Independent Radiologist Review | DOXIL | 18.8 | Percentage of participants | ||
| Objective Response Rate (ORR) - Independent Radiologist Review | Trabectedin/DOXIL | 27.6 | Percentage of participants | ||
| Duration of Response: Independent Radiologist Review | DOXIL | 7.7 | 95% Confidence Interval 6.5 to 9.0 | Months | |
| Duration of Response: Independent Radiologist Review | Trabectedin/DOXIL | 7.9 | 95% Confidence Interval 7.4 to 9.2 | Months | |
| Median Area Under Curve (AUC) of Trabectedin. | Trabectedin/DOXIL | 74.24 | ng*h/mL | ||
| Median Maximum Plasma Concentration (Cmax) of Trabectedin. | Trabectedin/DOXIL | 13394 | pg/mL |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | DOXIL | 335 | |
| Overall Study | STARTED | Trabectedin/DOXIL | 337 | |
| Overall Study | COMPLETED | DOXIL | 0 | |
| Overall Study | COMPLETED | Trabectedin/DOXIL | 0 | |
| Overall Study | NOT COMPLETED | DOXIL | 335 | |
| Overall Study | NOT COMPLETED | Trabectedin/DOXIL | 337 |
Source ClinicalTrials.gov
Adverse events456
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 | 160 | 333 | |
| other | Anaemia | Blood and lymphatic system disorders | DOXIL | 82 | 330 | |
| other | Leukopenia | Blood and lymphatic system disorders | Trabectedin/DOXIL | 164 | 333 | |
| other | Leukopenia | Blood and lymphatic system disorders | DOXIL | 91 | 330 | |
| other | Neutropenia | Blood and lymphatic system disorders | Trabectedin/DOXIL | 256 | 333 | |
| other | Neutropenia | Blood and lymphatic system disorders | DOXIL | 128 | 330 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Trabectedin/DOXIL | 115 | 333 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | DOXIL | 27 | 330 | |
| other | Abdominal Distension | Gastrointestinal disorders | Trabectedin/DOXIL | 18 | 333 | |
| other | Abdominal Distension | Gastrointestinal disorders | DOXIL | 23 | 330 |
1 to 10 of 456Source ClinicalTrials.gov
See all 456 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Trabectedin/DOXIL | ||
| Total, all-cause mortality | DOXIL | ||
| Total, other adverse events | Trabectedin/DOXIL | 333 | 333 |
| Total, other adverse events | DOXIL | 318 | 330 |
| Total, serious adverse events | Trabectedin/DOXIL | 133 | 333 |
| Total, serious adverse events | DOXIL | 102 | 330 |
Source ClinicalTrials.gov
Papers4
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Trabectedin/DOXIL vs DOXIL: serious adverse events |
Source 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/NCT00113607
GET https://conductscience.org/api/trials/v1/NCT00113607/events?page=2