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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 is a Phase 2 study that was terminated before completion, run by Eisai. The registered enrollment target is 8 participants.
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).
Interventions
- DRUG TMZ
- DRUG E7016
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2012-05 |
| Est. Completion | 2014-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01605162
The ClinicalTrials.gov registry entry for NCT01605162 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which TMZ is the first listed.
NCT01605162 reports 0 study locations.
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.
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