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NCT03746041 · ClinicalTrials.gov registry record · Phase 1
A Phase I Pilot Study of Abaloparatide + Bevacizumab in Myelodysplastic Syndromes
A Phase 1 study, sponsored by University of Rochester.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT03746041: Completed Phase 1 study, sponsored by University of Rochester.
NCT03746041 is a Phase 1 study that has completed, run by University of Rochester. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03746041, a Phase 1 study, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
The primary objective of this study is to determine the safety and tolerability of combined abaloparatide and bevacizumab in patients with Myelodysplastic Syndromes (MDS). A secondary objective is to determine the response to treatment (based on bone marrow and peripheral blood findings). A tertiary objective is to determine the impact of therapy on health-related quality of life (HRQOL) and patient-reported outcomes (PRO). A quaternary (scientific) objective is to determine the impact of treatment on both hematopoietic and stromal cell populations within the bone marrow of MDS patients.
Primary Outcome
Safety of this therapy will be based on subjects who complete at least two cycles, experiencing both study drugs for at least one cycle. TLT is defined as any serious AEs considered at least possibly due to abaloparatide and/or bevacizumab, occurring at any time from the initial dose of study treatment, with severity graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.
Interventions
- DRUG bevacizumab
- DRUG abaloparatide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-02-14 |
| Est. Completion | 2022-06-06 |
| Phase | Phase 1 |
What the finished NCT03746041 record still lists
NCT03746041 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which bevacizumab is the first listed.
NCT03746041 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03746041 about?
NCT03746041 is a clinical study titled "A Phase I Pilot Study of Abaloparatide + Bevacizumab in Myelodysplastic Syndromes". The primary objective of this study is to determine the safety and tolerability of combined abaloparatide and bevacizumab in patients with Myelodysplastic Syndromes (MDS). A secondary objective is to determine the response to treatment (based on bone marrow and peripheral blood findings). A tertiary...
What is the current status of trial NCT03746041?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2019-02-14. Estimated completion is 2022-06-06.
What interventions are being tested in trial NCT03746041?
The interventions under investigation include: bevacizumab (DRUG), abaloparatide (DRUG).
Who is sponsoring clinical trial NCT03746041?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03746041's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 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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