Trial · NCT01767155
Zoptarelin Doxorubicin (AEZS 108) as Second Line Therapy for Endometrial Cancer
NCT01767155, Phase 3, Completed, AEterna Zentaris; results first posted 2018-07-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Zoptarelin Doxorubicin (AEZS 108) as Second Line Therapy for Endometrial Cancer. Trials, record NCT01767155. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01767155
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Zoptarelin Doxorubicin (AEZS 108) as Second Line Therapy for Endometrial Cancer
- NCT number
- NCT01767155
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 511 participants, actual
- Lead sponsor
- AEterna Zentaris
- Conditions
- Endometrial Cancer
- Interventions
- AEZS-108 / zoptarelin doxorubicin, doxorubicin
- First posted
- 2013-01-14
- Last updated
- 2018-07-31
- Results first posted
- 2018-07-31
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Compare the Overall Survival (OS) of Patients Treated With AEZS-108 to the OS of Patients Treated With Doxorubicin. | From randomization to death from any cause. During ongoing treatment: response evaluation every 3 cycles. For patients gone of treatment: re-assessment every 12 weeks. | Overall survival was defined as the elapsed time from randomization to death from any cause. For surviving patients, follow-up was to be censored at the date of last contact. The final analysis, which was event-based, was conducted after approximately 384 randomized patients had died. A log-rank test with an overall two sided Type I Error rate of 0.05 after taking the interim analyses into account was used to compare OS between the two treatment arms via a SAS (Statistical Analysis System) LIFETEST procedure. Kaplan Meier estimates were used to calculate median OS and the 95% confidence interval (CI) of the median OS. The proportion of patients alive at 6 and 12 months (from randomization date) and the 95% CIs for these estimated proportions were calculated. |
| Secondary | Compare Efficacy Based on Objective Response Rate (ORR). | 3 years | The ORR was defined as the sum of the Complete Response (CR) and Partial Response (PR). CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) was to have a reduction in the short axis to \<10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. All responses were confirmed at least 4 weeks after the initial response was observed. Tumor assessments occurred every 3 cycles (± 7 days) during ongoing treatment then every 3 months (± 7 days) thereafter while the patient was on study. The last assessment occurred either when progression was confirmed or when approximately 384 randomized patients had died. |
| Secondary | Compare Efficacy Based on Progression-free Survival (PFS). | During ongoing treatment: response evaluation every 3 cycles. For patients gone of treatment: re-assessment every 12 weeks. | Progression-free survival (PFS): days between randomization and the date of documented progression or death for any cause that occurred up to the end of the study. For patients whose progression status could not be determined, their PFS data was censored for the last adequate progression assessment date that the patient was confirmed to have no progression. Response and progression were to be evaluated using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Changes in the largest diameter (uni-dimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes were to be used. During ongoing treatment, patients were to be re-evaluated for response every 3 cycles (i.e. every 9 weeks). A subsequent scan was obtained no earlier than 4 weeks following the initial documentation of an objective status of either complete response (CR) or partial response (PR). |
| Secondary | Compare Efficacy Based on Clinical Benefit Rate (CBR). | 3 years | Clinical benefit was defined as having stable disease (SD) or better lasting for at least 9 weeks. The CBR was analyzed using the same methods for the ORR analyses. The analysis of CBR (CR+PR+SD) was performed in the ITT (intention-to-treat) population. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) was to have a reduction in the short axis to \<10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. All responses were confirmed at least 4 weeks after the initial response was observed. Tumor assessments occurred every 3 cycles (± 7 days) during ongoing treatment then every 3 months (± 7 days) thereafter while the patient was on study. The last assessment occurred either when progression was confirmed or when approximately 384 randomized patients had died. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Compare the Overall Survival (OS) of Patients Treated With AEZS-108 to the OS of Patients Treated With Doxorubicin. | From randomization to death from any cause. During ongoing treatment: response evaluation every 3 cycles. For patients gone of treatment: re-assessment every 12 weeks. | participants | NUMBER | |
| SECONDARY | Compare Efficacy Based on Objective Response Rate (ORR). | 3 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Compare Efficacy Based on Progression-free Survival (PFS). | During ongoing treatment: response evaluation every 3 cycles. For patients gone of treatment: re-assessment every 12 weeks. | The population analyzed is the mITT. PFS was analyzed in the subset of patients from mITT that have CR, PR or stable disease (SD) as best overall response. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Compare Efficacy Based on Clinical Benefit Rate (CBR). | 3 years | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Compare the Overall Survival (OS) of Patients Treated With AEZS-108 to the OS of Patients Treated With Doxorubicin. | AEZS-108 / Zoptarelin Doxorubicin | Death Events | 196 | participants | |
| Compare the Overall Survival (OS) of Patients Treated With AEZS-108 to the OS of Patients Treated With Doxorubicin. | Doxorubicin/ Standard Chemotherapy | Death Events | 188 | participants | |
| Compare the Overall Survival (OS) of Patients Treated With AEZS-108 to the OS of Patients Treated With Doxorubicin. | AEZS-108 / Zoptarelin Doxorubicin | Censored | 60 | participants | |
| Compare the Overall Survival (OS) of Patients Treated With AEZS-108 to the OS of Patients Treated With Doxorubicin. | Doxorubicin/ Standard Chemotherapy | Censored | 67 | participants | |
| Compare the Overall Survival (OS) of Patients Treated With AEZS-108 to the OS of Patients Treated With Doxorubicin. | AEZS-108 / Zoptarelin Doxorubicin | Survivors at 6 months | 171 | participants | |
| Compare the Overall Survival (OS) of Patients Treated With AEZS-108 to the OS of Patients Treated With Doxorubicin. | Doxorubicin/ Standard Chemotherapy | Survivors at 6 months | 174 | participants | |
| Compare the Overall Survival (OS) of Patients Treated With AEZS-108 to the OS of Patients Treated With Doxorubicin. | AEZS-108 / Zoptarelin Doxorubicin | Survivors at 12 months | 111 | participants | |
| Compare the Overall Survival (OS) of Patients Treated With AEZS-108 to the OS of Patients Treated With Doxorubicin. | Doxorubicin/ Standard Chemotherapy | Survivors at 12 months | 106 | participants | |
| Compare Efficacy Based on Objective Response Rate (ORR). | AEZS-108 / Zoptarelin Doxorubicin | CR | 6 | Participants | |
| Compare Efficacy Based on Objective Response Rate (ORR). | Doxorubicin/ Standard Chemotherapy | CR | 5 | Participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AEZS-108 / Zoptarelin Doxorubicin | 256 | |
| Overall Study | STARTED | Doxorubicin/ Standard Chemotherapy | 255 | |
| Overall Study | Modified ITT (mITT) | AEZS-108 / Zoptarelin Doxorubicin | 252 | |
| Overall Study | Modified ITT (mITT) | Doxorubicin/ Standard Chemotherapy | 249 | |
| Overall Study | Safety Population (SAF) | AEZS-108 / Zoptarelin Doxorubicin | 252 | |
| Overall Study | Safety Population (SAF) | Doxorubicin/ Standard Chemotherapy | 249 | |
| Overall Study | COMPLETED | AEZS-108 / Zoptarelin Doxorubicin | 243 | |
| Overall Study | COMPLETED | Doxorubicin/ Standard Chemotherapy | 240 | |
| Overall Study | NOT COMPLETED | AEZS-108 / Zoptarelin Doxorubicin | 13 | |
| Overall Study | NOT COMPLETED | Doxorubicin/ Standard Chemotherapy | 15 |
Source ClinicalTrials.gov
Adverse events32
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 | Neutropenia | Blood and lymphatic system disorders | AEZS-108 / Zoptarelin Doxorubicin | 132 | 252 | |
| other | Neutropenia | Blood and lymphatic system disorders | Doxorubicin/ Standard Chemotherapy | 126 | 249 | |
| other | Nausea | Gastrointestinal disorders | AEZS-108 / Zoptarelin Doxorubicin | 120 | 252 | |
| other | Nausea | Gastrointestinal disorders | Doxorubicin/ Standard Chemotherapy | 125 | 249 | |
| other | Aneamia | Blood and lymphatic system disorders | AEZS-108 / Zoptarelin Doxorubicin | 107 | 252 | |
| other | Aneamia | Blood and lymphatic system disorders | Doxorubicin/ Standard Chemotherapy | 101 | 249 | |
| serious | Neutropenia | Blood and lymphatic system disorders | AEZS-108 / Zoptarelin Doxorubicin | 21 | 252 | |
| serious | Neutropenia | Blood and lymphatic system disorders | Doxorubicin/ Standard Chemotherapy | 15 | 249 | |
| serious | Anemia | Blood and lymphatic system disorders | AEZS-108 / Zoptarelin Doxorubicin | 16 | 252 | |
| serious | Anemia | Blood and lymphatic system disorders | Doxorubicin/ Standard Chemotherapy | 9 | 249 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AEZS-108 / Zoptarelin Doxorubicin | 196 | 252 |
| Total, all-cause mortality | Doxorubicin/ Standard Chemotherapy | 188 | 249 |
| Total, other adverse events | AEZS-108 / Zoptarelin Doxorubicin | 239 | 252 |
| Total, other adverse events | Doxorubicin/ Standard Chemotherapy | 240 | 249 |
| Total, serious adverse events | AEZS-108 / Zoptarelin Doxorubicin | 92 | 252 |
| Total, serious adverse events | Doxorubicin/ Standard Chemotherapy | 75 | 249 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36124638 | 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 |
|---|---|
| AEZS-108 / Zoptarelin Doxorubicin vs Doxorubicin/ Standard Chemotherapy: deaths from any cause | Trial comparisons |
| AEZS-108 / Zoptarelin Doxorubicin vs Doxorubicin/ Standard Chemotherapy: 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/NCT01767155
GET https://conductscience.org/api/trials/v1/NCT01767155/results?page=2