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NCT02234986 · ClinicalTrials.gov registry record · Phase 2
A Multi-center, Open-label Study of Oral ENMD-2076 for the Treatment of Patients With Advanced Fibrolamellar Carcinoma
A Phase 2 study, sponsored by CASI pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
NCT02234986: Completed Phase 2 study, sponsored by CASI pharmaceuticals.
NCT02234986 is a Phase 2 study that has completed, run by CASI pharmaceuticals. The registered enrollment target is 35 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02234986, a Phase 2 study, has completed, sponsored by CASI pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
Study Summary
The purpose of the study is to determine whether once-daily dosing with ENMD-2076 will be a safe and effective treatment in patients with FLC. Safety will be measured by looking at the adverse events that may happen and the efficacy will look at the progression of the disease over time.
Primary Outcome
6-month overall response rate (ORR rate) using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR) - disappearance of all target lesions; partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; ORR = proportion of patients evaluated as CR + PR
Interventions
- DRUG ENMD-2076
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2015-10 |
| Est. Completion | 2018-06-30 |
| Phase | Phase 2 |
What the finished NCT02234986 record still lists
NCT02234986 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 1 intervention - of which ENMD-2076 is the first listed.
NCT02234986 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02234986 about?
NCT02234986 is a clinical study titled "A Multi-center, Open-label Study of Oral ENMD-2076 for the Treatment of Patients With Advanced Fibrolamellar Carcinoma". The purpose of the study is to determine whether once-daily dosing with ENMD-2076 will be a safe and effective treatment in patients with FLC. Safety will be measured by looking at the adverse events that may happen and the efficacy will look at the progression of the disease over time.
What is the current status of trial NCT02234986?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2015-10. Estimated completion is 2018-06-30.
What interventions are being tested in trial NCT02234986?
The interventions under investigation include: ENMD-2076 (DRUG).
Who is sponsoring clinical trial NCT02234986?
This trial is sponsored by CASI pharmaceuticals, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02234986's enrollment target sits among peer trials
35 1524th of 2000 higher than 462 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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