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NCT01126736 · ClinicalTrials.gov registry record · Phase 1
Eribulin Mesylate Administered in Combination With Pemetrexed Versus Pemetrexed Alone as Second Line Therapy in Patients With Stage IIIB or IV Nonsquamous Non Small Cell Lung Cancer
A Phase 1 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 1
- Development phase
- 98
- Enrollment target
NCT01126736: Completed Phase 1 study, sponsored by Eisai.
NCT01126736 is a Phase 1 study that has completed, run by Eisai. The registered enrollment target is 98 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01126736, a Phase 1 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 98 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether Eribulin Mesylate Administered in Combination with Pemetrexed is safe and tolerable and to gain a preliminary indication of clinical benefit when administered to Patients with Stage IIIB or IV Nonsquamous Non Small Cell Lung Cancer.
Primary Outcome
DLT were defined as clinically significant adverse events (AE) occurring less than or equal to (\<=) 21 days after treatment. Events as: Non-hematological: 1) Grade greater than or equal to (\>=) 3 peripheral neuropathy; 2) Grade \>=3 nausea, vomiting despite optimal antiemetic treatment; 3) Any nonhematologic toxicity of Grade \>=3, with exceptions as alopecia, single laboratory values out of normal range, hypersensitivity reaction. Hematological:1) Grade 4 neutropenia lasting \>7 days; 2) Febr
Interventions
- DRUG pemetrexed
- DRUG eribulin mesylate
- DRUG Eribulin mesylate (eribulin; E7389)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2010-06-10 |
| Est. Completion | 2015-03-18 |
| Phase | Phase 1 |
What the finished NCT01126736 record still lists
NCT01126736 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% higher).
The record links to 0 conditions, and to 3 interventions - of which pemetrexed is the first listed.
NCT01126736 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01126736 about?
NCT01126736 is a clinical study titled "Eribulin Mesylate Administered in Combination With Pemetrexed Versus Pemetrexed Alone as Second Line Therapy in Patients With Stage IIIB or IV Nonsquamous Non Small Cell Lung Cancer". The purpose of this study is to determine whether Eribulin Mesylate Administered in Combination with Pemetrexed is safe and tolerable and to gain a preliminary indication of clinical benefit when administered to Patients with Stage IIIB or IV Nonsquamous Non Small Cell Lung Cancer.
What is the current status of trial NCT01126736?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 98 participants. The study started on 2010-06-10. Estimated completion is 2015-03-18.
What interventions are being tested in trial NCT01126736?
The interventions under investigation include: pemetrexed (DRUG), eribulin mesylate (DRUG), Eribulin mesylate (eribulin; E7389) (DRUG).
Who is sponsoring clinical trial NCT01126736?
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 NCT01126736's enrollment target sits among peer trials
98 592nd of 2000 higher than 1,404 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
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