Trial · NCT01840943
A Study to Compare CAELYX With Topotecan HCL in Patients With Recurrent Epithelial Ovarian Carcinoma Following Failure of First-Line, Platinum-Based Chemotherapy
NCT01840943, Phase 3, Terminated, Xian-Janssen Pharmaceutical Ltd.; results first posted 2015-12-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Compare CAELYX With Topotecan HCL in Patients With Recurrent Epithelial Ovarian Carcinoma Following Failure of First-Line, Platinum-Based Chemotherapy. Trials, record NCT01840943. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01840943
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Compare CAELYX With Topotecan HCL in Patients With Recurrent Epithelial Ovarian Carcinoma Following Failure of First-Line, Platinum-Based Chemotherapy
- NCT number
- NCT01840943
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 32 participants, actual
- Lead sponsor
- Xian-Janssen Pharmaceutical Ltd.
- Conditions
- Epithelial Ovarian Cancer
- Interventions
- CAELYX, Topotecan HCl
- First posted
- 2013-04-26
- Last updated
- 2015-12-23
- Results first posted
- 2015-12-23
- Limitations and caveats
- The study was terminated early as the total number of participants treated in this study was low and only descriptive analysis was used for efficacy and safety evaluation.
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Progression-free Survival Incidence at Week 24 | Week 24 | Progression-free survival incidence was be measured as number of participants who were progression-free and alive. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20 percent (%) 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 | Duration of Progression-free Survival | 1 year after the last dose (24 weeks) administration | It was calculated as the time, in weeks, from the day of randomization until documented disease progression or death due to any cause, whichever occurs first using a Kaplan-Meier curve for PFS. |
| Secondary | Number of Participants With Response | Up to Week 24 | Response rate was measured as number of participants with at least a durable response: Complete response (CR) or partial response (PR). Complete response is defined as the disappearance of all target lesions. Partial response is defined as at least a 30 percentage decrease in the sum of diameters of target lesions. Stable disease defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Progression in disease is defined as at least a 20% increase in the sum of diameters of target lesions. Not evaluable participants were those who were not analyzed. The reference of the baseline sum of diameters of lesions was considered. |
| Secondary | Time to Response | Up to Week 24 | It is calculated as the day of randomization to the first observation of a durable response (the first of the 2 confirmatory measurements). |
| Secondary | Duration of Response | Up to 1 year of last dose (Week 24) administration | It is calculated as the first observation of a durable response (the first of the 2 confirmatory measurements) to the first observation of disease progression or death due to any cause. |
| Secondary | Health-related Quality of Life Assessment (HQL) | Day 1 of each cycle of study medication and Week 4 after last dose of study medication | Calculation of each HQL domain scale will be performed according to the scoring guidelines for each of the HQL measures. The HQL analyses will include scales measuring physical functioning, pain, nausea, fatigue, and global quality of life. Each item is measured on a scale of 0 to 3, where 0 = no impact on quality of life and 3 = extreme impact on quality of life. |
| Secondary | Number of Participants With Overall Survival | Week 4 after the last dose of the study medication and approximately up to 1 year after the disease progression or completion of the study treatment or death, whichever is earlier | Number of Participants With Overall survival were categorized as number of 1) Deaths, 2) Still alive, 3) Early termination from the study due to lost to follow up, 4) Early termination from the study due to withdraw of consent, 5) Other. Overall survival is defined as the time interval from randomization to death from any cause. |
| Secondary | Maximum Plasma Concentration of CAELYX | 0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2 | |
| Secondary | Time to Reach the Maximum Plasma Concentration of CAELYX | 0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2 | |
| Secondary | Area Under the Plasma Concentration of CAELYX | 0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Progression-free Survival Incidence at Week 24 | Week 24 | The modified intent-to-treat population included (mITT) included all randomized participants. | participants | NUMBER |
| SECONDARY | Duration of Progression-free Survival | 1 year after the last dose (24 weeks) administration | The mITT population included all randomized participants. | weeks | MEDIAN |
| SECONDARY | Number of Participants With Response | Up to Week 24 | The mITT population included all randomized participants. | participants | NUMBER |
| SECONDARY | Time to Response | Up to Week 24 | The mITT population included all randomized participants.Time to response was analyzed for participants who achieved response. | weeks | MEDIAN |
| SECONDARY | Duration of Response | Up to 1 year of last dose (Week 24) administration | The mITT population included all randomized participants. Duration of response was analyzed for participants who achieved response. | weeks | MEDIAN |
| SECONDARY | Health-related Quality of Life Assessment (HQL) | Day 1 of each cycle of study medication and Week 4 after last dose of study medication | Data was not collected for this outcome measure as the study was early terminated. | ||
| SECONDARY | Number of Participants With Overall Survival | Week 4 after the last dose of the study medication and approximately up to 1 year after the disease progression or completion of the study treatment or death, whichever is earlier | The mITT population included all randomized participants. | participants | NUMBER |
| SECONDARY | Maximum Plasma Concentration of CAELYX | 0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2 | Data was not collected for this outcome measure as the study was early terminated. | ||
| SECONDARY | Time to Reach the Maximum Plasma Concentration of CAELYX | 0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2 | Data was not collected for this outcome measure as the study was early terminated. | ||
| SECONDARY | Area Under the Plasma Concentration of CAELYX | 0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2 | Data was not collected for this outcome measure as the study was early terminated. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Progression-free Survival Incidence at Week 24 | CAELYX | 6 | participants | ||
| Number of Participants With Progression-free Survival Incidence at Week 24 | Topotecan Hydrocloride (HCl) | 2 | participants | ||
| Duration of Progression-free Survival | CAELYX | NA | 95% Confidence Interval 8.0 to NA | weeks | |
| Duration of Progression-free Survival | Topotecan Hydrocloride (HCl) | 24.6 | 95% Confidence Interval 7.9 to 25.1 | weeks | |
| Number of Participants With Response | CAELYX | Complete Response (CR) | 0 | participants | |
| Number of Participants With Response | Topotecan Hydrocloride (HCl) | Complete Response (CR) | 0 | participants | |
| Number of Participants With Response | CAELYX | Partial Response (PR) | 5 | participants | |
| Number of Participants With Response | Topotecan Hydrocloride (HCl) | Partial Response (PR) | 3 | participants | |
| Number of Participants With Response | CAELYX | Stable Disease (SD) | 4 | participants | |
| Number of Participants With Response | Topotecan Hydrocloride (HCl) | Stable Disease (SD) | 6 | participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CAELYX | 14 | |
| Overall Study | STARTED | Topotecan Hydrocloride (HCl) | 12 | |
| Overall Study | COMPLETED | CAELYX | 1 | |
| Overall Study | COMPLETED | Topotecan Hydrocloride (HCl) | 0 | |
| Overall Study | NOT COMPLETED | CAELYX | 13 | |
| Overall Study | NOT COMPLETED | Topotecan Hydrocloride (HCl) | 12 |
Source ClinicalTrials.gov
Adverse events104
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 | Anemia | Blood and lymphatic system disorders | CAELYX | 5 | 14 | |
| other | Anemia | Blood and lymphatic system disorders | Topotecan Hydrocloride (HCl) | 11 | 12 | |
| other | Leukopenia | Blood and lymphatic system disorders | CAELYX | 5 | 14 | |
| other | Leukopenia | Blood and lymphatic system disorders | Topotecan Hydrocloride (HCl) | 2 | 12 | |
| other | Neutropenia | Blood and lymphatic system disorders | CAELYX | 5 | 14 | |
| other | Neutropenia | Blood and lymphatic system disorders | Topotecan Hydrocloride (HCl) | 1 | 12 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | CAELYX | 1 | 14 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Topotecan Hydrocloride (HCl) | 2 | 12 | |
| other | Leukocytosis | Investigations | CAELYX | 1 | 14 | |
| other | Leukocytosis | Investigations | Topotecan Hydrocloride (HCl) | 0 | 12 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CAELYX | ||
| Total, all-cause mortality | Topotecan Hydrocloride (HCl) | ||
| Total, other adverse events | CAELYX | 12 | 14 |
| Total, other adverse events | Topotecan Hydrocloride (HCl) | 12 | 12 |
| Total, serious adverse events | CAELYX | 1 | 14 |
| Total, serious adverse events | Topotecan Hydrocloride (HCl) | 1 | 12 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37407274 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CAELYX vs Topotecan Hydrocloride (HCl): Number of Participants With Progression-free Survival Incidence at Week 24 | Trial comparisons |
| CAELYX vs Topotecan Hydrocloride (HCl): 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/NCT01840943
GET https://conductscience.org/api/trials/v1/NCT01840943/results?page=2