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NCT01605162 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Study of the Poly(ADP-Ribose) Polymerase Inhibitor E7016 in Combination With Temozolomide in Subjects With Wild Type BRAF Stage IV or Unresectable Stage III Melanoma
A Phase 2 study, sponsored by Eisai.
- Terminated
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT01605162: Clinical Trial Phase 2 study, sponsored by Eisai.
NCT01605162 is a Phase 2 study that was terminated before completion, run by Eisai. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01605162, a Phase 2 study, was terminated before completion, sponsored by Eisai.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
This is a Phase 2, open-label, multicenter study to assess the PFS-6m of E7016 at the selected dose of 320-mg once daily (QD) in combination with 150-mg/m2 of Temozolomide (TMZ) in subjects with wt BRAF Stage IV or unresectable Stage III melanoma with disease progression. Eligible subjects must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST).
Primary Outcome
The Progression Free Survival-6m rate defined as the proportion of subjects that are alive and progression-free at 6-months from the date of first dosing based on RECIST 1.1. PFS-6m rate will be estimated from Kaplan-Meier (K-M) product-limit estimate of PFS.
Interventions
- DRUG TMZ
- DRUG E7016
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2012-05 |
| Est. Completion | 2014-02 |
| Phase | Phase 2 |
Why NCT01605162 stopped before completion
NCT01605162 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which TMZ is the first listed.
NCT01605162 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01605162 about?
NCT01605162 is a clinical study titled "Phase 2 Study of the Poly(ADP-Ribose) Polymerase Inhibitor E7016 in Combination With Temozolomide in Subjects With Wild Type BRAF Stage IV or Unresectable Stage III Melanoma". This is a Phase 2, open-label, multicenter study to assess the PFS-6m of E7016 at the selected dose of 320-mg once daily (QD) in combination with 150-mg/m2 of Temozolomide (TMZ) in subjects with wt BRAF Stage IV or unresectable Stage III melanoma with disease progression. Eligible subjects must have...
What is the current status of trial NCT01605162?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2012-05. Estimated completion is 2014-02.
What interventions are being tested in trial NCT01605162?
The interventions under investigation include: TMZ (DRUG), E7016 (DRUG).
Who is sponsoring clinical trial NCT01605162?
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 NCT01605162's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 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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