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NCT01433991 · ClinicalTrials.gov registry record · Phase 1
A Study of E7050 in Combination With E7080 in Participants With Advanced Solid Tumors (Dose Escalation) and in Participants With Recurrent Glioblastoma or Unresectable Stage III or Stage IV Melanoma After Prior Systemic Therapy (Expansion Cohort and Phase 2)
A Phase 1 study, sponsored by Eisai.
- Terminated
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT01433991 is a Phase 1 study that was terminated before completion, run by Eisai. The registered enrollment target is 30 participants.
The verdict
NCT01433991, a Phase 1 study, was terminated before completion, sponsored by Eisai.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This is a multicenter, open-label, Phase 1b/2 study which will be conducted in two parts: a Phase 1b part comprising a dose escalation and an expansion cohort; and a Phase 2 part which will comprise two cohorts. The purpose of the Phase 1b part is to identify the maximum tolerated dose (MTD) of E7050 and E7080 (lenvatinib) in combination in participants with unresectable advanced or metastatic solid tumors. In the subsequent Phase 1b expansion cohort and Phase 2 cohorts, additional participants with recurrent glioblastoma or unresectable Stage III or Stage IV melanoma and disease progression after prior systemic treatment will be enrolled to confirm the MTD (expansion cohort) and to further explore the clinical activity of E7050 and lenvatinib.
Interventions
- DRUG Lenvatinib
- DRUG Golvatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2011-10-13 |
| Est. Completion | 2017-03-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01433991
The ClinicalTrials.gov registry entry for NCT01433991 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 30 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 Lenvatinib is the first listed.
NCT01433991 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01433991 about?
NCT01433991 is a clinical study titled "A Study of E7050 in Combination With E7080 in Participants With Advanced Solid Tumors (Dose Escalation) and in Participants With Recurrent Glioblastoma or Unresectable Stage III or Stage IV Melanoma After Prior Systemic Therapy (Expansion Cohort and Phase 2)". This is a multicenter, open-label, Phase 1b/2 study which will be conducted in two parts: a Phase 1b part comprising a dose escalation and an expansion cohort; and a Phase 2 part which will comprise two cohorts. The purpose of the Phase 1b part is to identify the maximum tolerated dose (MTD) of E705...
What is the current status of trial NCT01433991?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2011-10-13. Estimated completion is 2017-03-01.
What interventions are being tested in trial NCT01433991?
The interventions under investigation include: Lenvatinib (DRUG), Golvatinib (DRUG).
Who is sponsoring clinical trial NCT01433991?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
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