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NCT02753595 · ClinicalTrials.gov registry record · Phase 1
Study of Eribulin Mesylate in Combination With PEGylated Recombinant Human Hyaluronidase (PEGPH20) Versus Eribulin Mesylate Alone in Subjects With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative, High-Hyaluronan (HA) Metastatic Breast Cancer (MBC)
A Phase 1 study, sponsored by Eisai.
- Terminated
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT02753595: Clinical Trial Phase 1 study, sponsored by Eisai.
NCT02753595 is a Phase 1 study that was terminated before completion, run by Eisai. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02753595, a Phase 1 study, was terminated before completion, sponsored by Eisai.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
The primary objective for the study is as follows: For the Phase 1b - to determine safety tolerability and recommended Phase 2 dose (RP2D) of eribulin mesylate in combination with PEGylated recombinant human hyaluronidase (PEGPH20) in participants with Human Epidermal Growth Factor Receptor (HER2)-negative metastatic breast cancer (MBC) previously treated with up to two lines of systemic anticancer therapy in the metastatic setting. For the Phase 2 - to evaluate objective response rate (ORR) of eribulin mesylate in combination with PEGPH20 in participants with HER2-negative, High-Hyaluronan (HA)-high, MBC previously treated with up to 2 lines of systemic anticancer therapy in the metastatic setting.
Primary Outcome
The RP2D was the maximum tolerated dose (MTD) or less. The MTD was determined as the dose level (1, 0) at which less than or equal to (\<=) 1 of 6 evaluable participants experienced dose limiting toxicity (DLT) within the first 21 days of treatment (end of Cycle 1). Upon determination of RP2D in Cycle 1 of Phase 1b, RP2D was to be confirmed in Phase 1b-expansion Part.
Interventions
- DRUG Eribulin mesylate
- OTHER Biologic: PEGylated recombinant human hyaluronidase (PEGPH20)
- OTHER Biologic: PEGylated recombinant human hyaluronidase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2016-07-13 |
| Est. Completion | 2019-08-16 |
| Phase | Phase 1 |
Why NCT02753595 stopped before completion
NCT02753595 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 3 interventions - of which Eribulin mesylate is the first listed.
NCT02753595 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02753595 about?
NCT02753595 is a clinical study titled "Study of Eribulin Mesylate in Combination With PEGylated Recombinant Human Hyaluronidase (PEGPH20) Versus Eribulin Mesylate Alone in Subjects With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative, High-Hyaluronan (HA) Metastatic Breast Cancer (MBC)". The primary objective for the study is as follows: For the Phase 1b - to determine safety tolerability and recommended Phase 2 dose (RP2D) of eribulin mesylate in combination with PEGylated recombinant human hyaluronidase (PEGPH20) in participants with Human Epidermal Growth Factor Receptor (HER2)-...
What is the current status of trial NCT02753595?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2016-07-13. Estimated completion is 2019-08-16.
What interventions are being tested in trial NCT02753595?
The interventions under investigation include: Eribulin mesylate (DRUG), Biologic: PEGylated recombinant human hyaluronidase (PEGPH20) (OTHER), Biologic: PEGylated recombinant human hyaluronidase (OTHER).
Who is sponsoring clinical trial NCT02753595?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02753595's enrollment target sits among peer trials
25 1495th of 2000 higher than 481 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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