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NCT01136967 · ClinicalTrials.gov registry record · Phase 2
An Open-Label, 2-Cohort, Multicenter, Study of Lenvatinib in Previously Treated Subjects With Unresectable Stage III or Stage IV Melanoma
A Phase 2 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 2
- Development phase
- 182
- Enrollment target
NCT01136967: Completed Phase 2 study, sponsored by Eisai.
NCT01136967 is a Phase 2 study that has completed, run by Eisai. The registered enrollment target is 182 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01136967, a Phase 2 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 182 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the objective response rate of lenvatinib in previously treated participants with American Joint Committee on Cancer (AJCC) unresectable Stage III or Stage IV melanoma and disease progression.
Primary Outcome
ORR, (ORR = CR + PR) was defined as the percentage of participants in each cohort who had a best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 for target lesions assessed by magnetic resonance imaging/computed tomography (MRI/CT) scans and independent radiologic review (IRR). A BOR of CR required confirmation by a subsequent CR assessment at least 4 weeks later. A BOR of PR required confirmation by a
Interventions
- DRUG Lenvatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 182 participants |
| Start Date | 2010-08 |
| Est. Completion | 2014-11 |
| Phase | Phase 2 |
What the finished NCT01136967 record still lists
NCT01136967 is an interventional study that assigns participants to a tested intervention. The registered 182 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% higher).
The record links to 0 conditions, and to 1 intervention - of which Lenvatinib is the first listed.
NCT01136967 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01136967 about?
NCT01136967 is a clinical study titled "An Open-Label, 2-Cohort, Multicenter, Study of Lenvatinib in Previously Treated Subjects With Unresectable Stage III or Stage IV Melanoma". The purpose of this study is to assess the objective response rate of lenvatinib in previously treated participants with American Joint Committee on Cancer (AJCC) unresectable Stage III or Stage IV melanoma and disease progression.
What is the current status of trial NCT01136967?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 182 participants. The study started on 2010-08. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01136967?
The interventions under investigation include: Lenvatinib (DRUG).
Who is sponsoring clinical trial NCT01136967?
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 NCT01136967's enrollment target sits among peer trials
182 363rd of 2000 higher than 1,636 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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