Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01126749 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study, sponsored by Eisai.
- Terminated
- Registry status
- Phase 1
- Development phase
- 92
- Enrollment target
NCT01126749: Clinical Trial Phase 1 study, sponsored by Eisai.
NCT01126749 is a Phase 1 study that was terminated before completion, run by Eisai. The registered enrollment target is 92 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01126749, a Phase 1 study, was terminated before completion, sponsored by Eisai.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 92 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether Patients with Locally Advanced or Metastatic Bladder Cancer who receive Eribulin Mesylate Administered in Combination with Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Alone as First-Line Therapy is safety and tolerable when administered to patients with locally advanced or metastatic bladder cancer and to gain preliminary data on whether patients may benefit from this combination.
Primary Outcome
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 h
Interventions
- DRUG Cisplatin
- DRUG Gemcitabine
- DRUG E7389
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2010-04-16 |
| Est. Completion | 2016-07-20 |
| Phase | Phase 1 |
Why NCT01126749 stopped before completion
NCT01126749 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% higher).
The record links to 0 conditions, and to 3 interventions - of which Cisplatin is the first listed.
NCT01126749 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01126749 about?
NCT01126749 is a clinical study titled "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". The purpose of this study is to determine whether Patients with Locally Advanced or Metastatic Bladder Cancer who receive Eribulin Mesylate Administered in Combination with Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Alone as First-Line Therapy is safety and tolerable when administe...
What is the current status of trial NCT01126749?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 92 participants. The study started on 2010-04-16. Estimated completion is 2016-07-20.
What interventions are being tested in trial NCT01126749?
The interventions under investigation include: Cisplatin (DRUG), Gemcitabine (DRUG), E7389 (DRUG).
Who is sponsoring clinical trial NCT01126749?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01126749's enrollment target sits among peer trials
92 625th of 2000 higher than 1,375 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03184545 · 92 participants · Phase 3
Comparing the Outcome of Electrical Stimulation and Physical Therapy in Patellofemoral Pain Syndrome
- NCT04172532 · 92 participants · Phase 1
Testing the Addition of a New Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiotherapy in Patients With Locally Advanced Pancreatic Cancer
- NCT04508088 · 92 participants
Skeletal Health and Bone Marrow Composition in Newly Diagnosed Adolescents With Crohn Disease
- NCT04840602 · 92 participants · Phase 2
Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib Plus Rituximab or Zanubrutinib Alone) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI