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NCT03344536 · ClinicalTrials.gov registry record · Phase 1
A Study of Debio 1347 Plus Fulvestrant in Patients With Metastatic Breast Cancer
A Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT03344536: Completed Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.
NCT03344536 is a Phase 1 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03344536, a Phase 1 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
The purpose of a phase Ib study is to find out the best or maximum tolerated dose of a medication or combination of medications. Therefore, the purpose of this study is to decide the best dose of the study drug, Debio 1347, that can be given in combination with the standard hormonal drug, fulvestrant. Debio 1347 and fulvestrant could shrink the cancer but it could also cause side effects. This study tells us about the side effects of these drugs when given in this new combination, and how often they occur.
Primary Outcome
Selected non-hematologic and hematologic toxicities, as measured by the NCI CTCAE Version 4.0, will be described by frequency and grade, by cycle and over all cycles, with the maximum grade over all cycles used as the summary measure per patient.
Interventions
- DRUG Fulvestrant
- DRUG Debio 1347
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2017-11-10 |
| Est. Completion | 2021-08-12 |
| Phase | Phase 1 |
What the finished NCT03344536 record still lists
NCT03344536 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Fulvestrant is the first listed.
NCT03344536 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03344536 about?
NCT03344536 is a clinical study titled "A Study of Debio 1347 Plus Fulvestrant in Patients With Metastatic Breast Cancer". The purpose of a phase Ib study is to find out the best or maximum tolerated dose of a medication or combination of medications. Therefore, the purpose of this study is to decide the best dose of the study drug, Debio 1347, that can be given in combination with the standard hormonal drug, fulvestran...
What is the current status of trial NCT03344536?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2017-11-10. Estimated completion is 2021-08-12.
What interventions are being tested in trial NCT03344536?
The interventions under investigation include: Fulvestrant (DRUG), Debio 1347 (DRUG).
Who is sponsoring clinical trial NCT03344536?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03344536's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 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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