Trial · NCT01126749
Eribulin Mesylate Administered in Combination With Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Alone as First-Line Therapy for Locally Advanced or Metastatic Bladder Cancer
NCT01126749, Phase 1, Phase 2, Terminated, Eisai Inc.; results first posted 2022-02-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Eribulin Mesylate Administered in Combination With Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Alone as First-Line Therapy for Locally Advanced or Metastatic Bladder Cancer. Trials, record NCT01126749. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01126749
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Eribulin Mesylate Administered in Combination With Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Alone as First-Line Therapy for Locally Advanced or Metastatic Bladder Cancer
- NCT number
- NCT01126749
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 92 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Bladder Cancer
- Interventions
- Gemcitabine, E7389, Cisplatin
- First posted
- 2010-05-20
- Last updated
- 2022-02-28
- Other registries' IDs
- eudract:2009-015915-42
- Results first posted
- 2022-02-28
- Limitations and caveats
Due to the lack of a clear definition for PFS censoring rules and deviation from the statistical analysis plan relating to interim analyses, the PFS analysis was deemed unreliable and therefore data was not collected and reported.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1b: Number of Participants With Dose-limiting Toxicity (DLT) as Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0 | Cycle 1 (Cycle length=21 days) | DLTs were clinically significant adverse events within 21 days of treatment judged by investigator at least possibly related to treatment. This included greater than or equal to (\>=) Grade 3 (G3) peripheral neuropathy, \>=G3 nausea and vomiting despite optimal anti-emetic treatment, any other non-hematologic toxicity of \>=G3 (except alopecia, single abnormal laboratory values the Investigator judged unlikely related to study therapy, had no clinical correlate, and resolved within 7 days, and hypersensitivity reaction to any of the compounds), Grade 4 neutropenia lasting over 7 days, febrile neutropenia (defined as fever \>=38.5 degrees Celsius with absolute neutrophil count below 1.0\*10\^9 per liter, G3 thrombocytopenia with nontraumatic bleeding (without therapeutic systemic anticoagulation) requiring platelet transfusion, Grade 4 thrombocytopenia (with or without nontraumatic bleeding), any study drug-related death, any other toxicity the dose escalation committee believed to be DLT. |
| Primary | Phase 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From the first dose of study drug up to approximately 6 years 3 months | TEAE was defined as an adverse event that had an onset date, or a worsening in severity on or after the first dose of study drug up to the end of the study. Number of participants with TEAEs were reported based on safety assessments of laboratory tests, physical examination, examining bowel movements, regular measurement of vital signs, eastern cooperative oncology group-performance status and electrocardiogram parameter values. SAE was any untoward medical occurrence that at any dose: resulted in death; life threatening required inpatient hospitalization; resulted in persistent, significant disability; was congenital anomaly/birth defect or medically important due to other reasons than mentioned criteria. Number of participants with TEAEs and SAEs were reported. |
| Secondary | Phase 2: Progression-free Survival (PFS) | From the date of randomization until the earlier of the following two events: the date of PD or the date of death (Up to approximately 6 years 3 months) | PFS was defined as the time from the date of randomization until the earlier of the following two events: the date of disease progression (PD) or the date of death based on response evaluation criteria in solid tumor (RECIST) version (v) 1.1. PD was defined as at least a 20 percent (%) increase or 5 millimeter (mm) increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. |
| Secondary | Phase 2: Percentage of Participants With Overall Response | From the date of randomization until CR or PR (Up to approximately 6 years 3 months) | Overall response rate was defined as the percentage of participants with the best confirmed response of complete response (CR) or partial response (PR) based on RECIST v1.1. CR was defined as complete disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline summed longest diameters. |
| Secondary | Phase 2: Percentage of Participants With Progression-free Survival at Week 12 | Week 12 | PFS was defined as the time from the date of randomization until the earlier of the following two events: the date of PD or the date of death based on RECIST v1.1. PD was defined as at least a 20% increase or 5 mm increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. |
| Secondary | Phase 2: Time to Progression (TTP) | From the date of randomization until the date of PD (Up to approximately 6 years 3 months) | TTP was defined as the time from the date of randomization until the date of PD based on RECIST v1.1. PD was defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking in reference the smallest summed longest diameters on study (this included the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. The appearance of 1 or more new lesions was also considered progression. |
| Secondary | Phase 2: Overall Survival (OS) | From the date of randomization until the date of death (Up to approximately 6 years 3 months) | OS was defined as the time from the date of randomization until the date of death due to any cause. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1b: Number of Participants With Dose-limiting Toxicity (DLT) as Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0 | Cycle 1 (Cycle length=21 days) | SAS included all participants who were randomized and treated in Phase 1b of this study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From the first dose of study drug up to approximately 6 years 3 months | SAS included all participants who were randomized and treated in Phase 2 of this study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase 2: Progression-free Survival (PFS) | From the date of randomization until the earlier of the following two events: the date of PD or the date of death (Up to approximately 6 years 3 months) | Modified intent-to-treat (MITT) analysis set included all participants who were randomized and received at least one dose of study medication without major protocol eligibility violations. Due to the lack of a clear definition for PFS censoring rules and deviation from the statistical analysis plan relating to interim analyses, the PFS analysis was deemed unreliable and therefore data was not collected and reported. | ||
| SECONDARY | Phase 2: Percentage of Participants With Overall Response | From the date of randomization until CR or PR (Up to approximately 6 years 3 months) | MITT analysis set included all participants who were randomized and received at least one dose of study medication without major protocol eligibility violations. | percentage of participants | NUMBER |
| SECONDARY | Phase 2: Percentage of Participants With Progression-free Survival at Week 12 | Week 12 | MITT analysis set included all participants who were randomized and received at least one dose of study medication without major protocol eligibility violations. Due to the lack of a clear definition for PFS censoring rules and deviation from the statistical analysis plan relating to interim analyses, the PFS analysis was deemed unreliable and therefore data was not collected and reported. | ||
| SECONDARY | Phase 2: Time to Progression (TTP) | From the date of randomization until the date of PD (Up to approximately 6 years 3 months) | MITT analysis set included all participants who were randomized and received at least one dose of study medication without major protocol eligibility violations. Due to the lack of a clear definition for PFS censoring rules and deviation from the statistical analysis plan relating to interim analyses, the PFS analysis was deemed unreliable and therefore data was not collected and reported. | ||
| SECONDARY | Phase 2: Overall Survival (OS) | From the date of randomization until the date of death (Up to approximately 6 years 3 months) | MITT analysis set included all participants who were randomized and received at least one dose of study medication without major protocol eligibility violations. | weeks | MEDIAN |
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 |
|---|---|---|---|---|---|
| Phase 1b: Number of Participants With Dose-limiting Toxicity (DLT) as Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0 | Phase 1b: Eribulin Mesylate 0.7 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2 | 0 | Participants | ||
| Phase 1b: Number of Participants With Dose-limiting Toxicity (DLT) as Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0 | Phase 1b: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2 | 1 | Participants | ||
| Phase 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Phase 2: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2 | TEAEs | 41 | Participants | |
| Phase 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Phase 2: Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2 | TEAEs | 38 | Participants | |
| Phase 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Phase 2: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2 | SAEs | 22 | Participants | |
| Phase 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Phase 2: Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2 | SAEs | 14 | Participants | |
| Phase 2: Percentage of Participants With Overall Response | Phase 2: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2 | 52.5 | 95% Confidence Interval 37.0 to 68.0 | percentage of participants | |
| Phase 2: Percentage of Participants With Overall Response | Phase 2: Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2 | 46.2 | 95% Confidence Interval 30.5 to 61.8 | percentage of participants | |
| Phase 2: Overall Survival (OS) | Phase 2: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2 | 62.9 | 95% Confidence Interval 39.86 to 132.0 | weeks | |
| Phase 2: Overall Survival (OS) | Phase 2: Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2 | 64.6 | 95% Confidence Interval 50.43 to 126.4 | weeks |
Source ClinicalTrials.gov
Participant flow32
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase 1b | STARTED | Phase 1b: Eribulin Mesylate 0.7 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2 | 3 | |
| Phase 1b | STARTED | Phase 1b: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2 | 6 | |
| Phase 1b | STARTED | Phase 2: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2 | 0 | |
| Phase 1b | STARTED | Phase 2: Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2 | 0 | |
| Phase 1b | COMPLETED | Phase 1b: Eribulin Mesylate 0.7 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2 | 0 | |
| Phase 1b | COMPLETED | Phase 1b: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2 | 0 | |
| Phase 1b | COMPLETED | Phase 2: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2 | 0 | |
| Phase 1b | COMPLETED | Phase 2: Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2 | 0 | |
| Phase 1b | NOT COMPLETED | Phase 1b: Eribulin Mesylate 0.7 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2 | 3 | |
| Phase 1b | NOT COMPLETED | Phase 1b: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2 | 6 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 participant flowAdverse events1,072
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 | Phase 1b: Eribulin Mesylate 0.7 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2 | 3 | 3 | 7 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1b: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2 | 5 | 6 | 14 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2 | 22 | 41 | 30 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2: Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2 | 22 | 39 | 34 |
| other | Leukopenia | Blood and lymphatic system disorders | Phase 1b: Eribulin Mesylate 0.7 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2 | 0 | 3 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Phase 1b: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2 | 3 | 6 | 6 |
| other | Leukopenia | Blood and lymphatic system disorders | Phase 2: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2 | 12 | 41 | 41 |
| other | Leukopenia | Blood and lymphatic system disorders | Phase 2: Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2 | 7 | 39 | 22 |
| other | Neutropenia | Blood and lymphatic system disorders | Phase 1b: Eribulin Mesylate 0.7 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2 | 3 | 3 | 13 |
| other | Neutropenia | Blood and lymphatic system disorders | Phase 1b: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2 | 3 | 6 | 21 |
1 to 10 of 1,072Source ClinicalTrials.gov
See all 1,072 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1b: Eribulin Mesylate 0.7 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2 | 3 | 3 |
| Total, all-cause mortality | Phase 1b: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2 | 4 | 6 |
| Total, all-cause mortality | Phase 2: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2 | 22 | 41 |
| Total, all-cause mortality | Phase 2: Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2 | 22 | 39 |
| Total, other adverse events | Phase 1b: Eribulin Mesylate 0.7 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2 | 3 | 3 |
| Total, other adverse events | Phase 1b: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2 | 6 | 6 |
| Total, other adverse events | Phase 2: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2 | 41 | 41 |
| Total, other adverse events | Phase 2: Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2 | 38 | 39 |
| Total, serious adverse events | Phase 1b: Eribulin Mesylate 0.7 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2 | 0 | 3 |
| Total, serious adverse events | Phase 1b: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2 | 1 | 6 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
Phase 1b: Eribulin Mesylate 0.7 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2 vs Phase 1b: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2: Phase 1b: Number of Participants With Dose-limiting Toxicity (DLT) as Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0 |
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
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