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NCT01418677 · ClinicalTrials.gov registry record · Phase 1
An Open-Label Study to Assess the Pharmacokinetics and Safety of HALAVEN in Subjects With Cancer Who Also Have Impaired Renal Function
A Phase 1 study of Unspecified Adult Solid Tumor, Protocol Specific, sponsored by Eisai.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
- 9
- Study locations
NCT01418677: Completed Phase 1 study of Unspecified Adult Solid Tumor, Protocol Specific, sponsored by Eisai.
NCT01418677 is a Phase 1 study of Unspecified Adult Solid Tumor, Protocol Specific that has completed, run by Eisai. The registered enrollment target is 19 participants, below the 501-participant average among 83 other Unspecified Adult Solid Tumor, Protocol Specific trials with a reported enrollment target (96% lower). The trial reports 9 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01418677, a Phase 1 study of Unspecified Adult Solid Tumor, Protocol Specific, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
- 9
- Study locations
Study Summary
This is an open-label non-randomized study in subjects with advanced or metastatic solid tumors who are no longer responding to available therapy. HALAVEN will be administered to subjects on Days 1 and 8 of a 21-day cycle.
Primary Outcome
The primary analysis will be conducted using the dose-normalized primary PK parameters (AUC0-inf, AUC0-last, and Cmax) respectively. Relationships between each individual PK parameter and renal function (creatinine clearance) will be analyzed by linear regression models using the PK parameter as the dependent variable and renal function as the independent variable.
Conditions Studied
Interventions
- DRUG E7389
Study Locations (9)
California
- - Duarte
Florida
- - Miami
Georgia
- - Atlanta
Michigan
- - Detroit
Minnesota
- - Minneapolis
Missouri
- - St Louis
New Jersey
- - New Brunswick
New York
- - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2011-10 |
| Est. Completion | 2015-05 |
| Phase | Phase 1 |
What the finished NCT01418677 record still lists
NCT01418677 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 501-participant average among 83 other Unspecified Adult Solid Tumor, Protocol Specific trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Unspecified Adult Solid Tumor, Protocol Specific appearing as the primary indexed condition, and to 1 intervention - of which E7389 is the first listed.
NCT01418677 lists 9 locations in 9 states (California, Florida, Georgia).
Frequently Asked Questions
What is clinical trial NCT01418677 about?
NCT01418677 is a clinical study titled "An Open-Label Study to Assess the Pharmacokinetics and Safety of HALAVEN in Subjects With Cancer Who Also Have Impaired Renal Function". This is an open-label non-randomized study in subjects with advanced or metastatic solid tumors who are no longer responding to available therapy. HALAVEN will be administered to subjects on Days 1 and 8 of a 21-day cycle.
What is the current status of trial NCT01418677?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2011-10. Estimated completion is 2015-05.
What conditions does trial NCT01418677 study?
This clinical trial studies the following conditions: Unspecified Adult Solid Tumor, Protocol Specific.
What interventions are being tested in trial NCT01418677?
The interventions under investigation include: E7389 (DRUG).
Who is sponsoring clinical trial NCT01418677?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01418677 being conducted?
This trial has 9 study locations across California, Florida, Georgia, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Unspecified Adult Solid Tumor, Protocol Specific
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01418677's enrollment target sits among peer trials
19 78th of 83 higher than 6 of 83 other Unspecified Adult Solid Tumor, Protocol Specific trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Unspecified Adult Solid Tumor, Protocol Specific 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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