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NCT01554371 · ClinicalTrials.gov registry record · Phase 1
Eribulin in Combination With Cyclophosphamide in Patients With Solid Tumor Malignancies
A Phase 1 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
NCT01554371: Completed Phase 1 study, sponsored by University of California, San Francisco.
NCT01554371 is a Phase 1 study that has completed, run by University of California, San Francisco. The registered enrollment target is 44 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01554371, a Phase 1 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
Study Summary
The purpose of this study is to test the safety of eribulin (Halaven™) and cyclophosphamide (Cytoxan®) given together at different doses. This study will look at what effects, good and/or bad, that these drugs have on solid tumors. Eribulin is a drug that has been approved by the FDA for breast cancer that has spread to other parts of the body. Cyclophosphamide has been approved for different types of cancers (including breast cancer). However, the combination of eribulin and cyclophosphamide is considered experimental; that means this combination has not been approved by the FDA. The funding for this study is provided by Eisai Inc., the maker of eribulin.
Primary Outcome
Standard dose-confirmation design of 3 to 6 participants per cohort (3+3 design) was used to determine the MTD of eribulin in combination with cyclophosphamide for participants with any solid tumor. The highest dose level or MTD is reached when no more than one of six participants experience a Dose Limiting Toxicity (DLTs). A DLT is defined as any treatment-related toxicity in first 28 days of therapy with a grade 3 or 4 non-hematologic toxicity, a grade 4 neutropenia or thrombocytopenia lasting
Interventions
- DRUG Cyclophosphamide
- DRUG Eribulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2012-03-27 |
| Est. Completion | 2019-12-31 |
| Phase | Phase 1 |
What the finished NCT01554371 record still lists
NCT01554371 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 2 interventions - of which Cyclophosphamide is the first listed.
NCT01554371 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01554371 about?
NCT01554371 is a clinical study titled "Eribulin in Combination With Cyclophosphamide in Patients With Solid Tumor Malignancies". The purpose of this study is to test the safety of eribulin (Halaven™) and cyclophosphamide (Cytoxan®) given together at different doses. This study will look at what effects, good and/or bad, that these drugs have on solid tumors. Eribulin is a drug that has been approved by the FDA for breast canc...
What is the current status of trial NCT01554371?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2012-03-27. Estimated completion is 2019-12-31.
What interventions are being tested in trial NCT01554371?
The interventions under investigation include: Cyclophosphamide (DRUG), Eribulin (DRUG).
Who is sponsoring clinical trial NCT01554371?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01554371's enrollment target sits among peer trials
44 1086th of 2000 higher than 901 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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