Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01133756 · ClinicalTrials.gov registry record · Phase 1
E7080 in Combination With Carboplatin + Gemcitabine Versus Carboplatin + Gemcitabine Alone as Second Line Therapy in Patients With Platinum-Sensitive Recurrent Ovarian Cancer by CA125
A Phase 1 study, sponsored by Eisai.
- Terminated
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT01133756: Clinical Trial Phase 1 study, sponsored by Eisai.
NCT01133756 is a Phase 1 study that was terminated before completion, run by Eisai. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01133756, a Phase 1 study, was terminated before completion, sponsored by Eisai.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
The purpose of this study was to determine the maximum tolerated dose (MTD)/recommended Phase II dose of lenvatinib administered in combination with carboplatin and gemcitabine (Phase IB) and to evaluate the safety and tolerability of E7080 administered in combination with carboplatin and gemcitabine compared to carboplatin and gemcitabine alone (Phase II) in participants with platinum-sensitive recurrent ovarian cancer.
Primary Outcome
DLTs were defined as clinically significant adverse events occurring less than or equal to 21 days after commencing study treatment and considered to be possibly or probably related to study treatment by the Investigator. If 1 DLT occurred at any dose level, the cohort was to be expanded to include a maximum of six evaluable subjects. If 2 DLTs occurred at any dose level, the maximum tolerated dose (MTD) was to be either defined as the preceding dose, or an intermediate dose. To evaluate an inte
Interventions
- DRUG Carboplatin
- DRUG Gemcitabine
- DRUG Lenvatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2010-03 |
| Est. Completion | 2012-09 |
| Phase | Phase 1 |
Why NCT01133756 stopped before completion
NCT01133756 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 3 interventions - of which Carboplatin is the first listed.
NCT01133756 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01133756 about?
NCT01133756 is a clinical study titled "E7080 in Combination With Carboplatin + Gemcitabine Versus Carboplatin + Gemcitabine Alone as Second Line Therapy in Patients With Platinum-Sensitive Recurrent Ovarian Cancer by CA125". The purpose of this study was to determine the maximum tolerated dose (MTD)/recommended Phase II dose of lenvatinib administered in combination with carboplatin and gemcitabine (Phase IB) and to evaluate the safety and tolerability of E7080 administered in combination with carboplatin and gemcitabin...
What is the current status of trial NCT01133756?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2010-03. Estimated completion is 2012-09.
What interventions are being tested in trial NCT01133756?
The interventions under investigation include: Carboplatin (DRUG), Gemcitabine (DRUG), Lenvatinib (DRUG).
Who is sponsoring clinical trial NCT01133756?
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 NCT01133756's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 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 registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia