Trial · Interventional
CompletedPhase 1Registry dataA Phase I Pilot Study of Abaloparatide + Bevacizumab in Myelodysplastic Syndromes
Overview
- Status
- Completed
- Phase
- Phase 1
- Enrollment
- 20 participants (actual)
- Sponsor
- University of Rochester · Other
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
United States
- Start
- 14 Feb 2019
- Primary completion
- 1 Apr 2022
- Completion
- 6 Jun 2022
- First posted
- 19 Nov 2018
- Last update posted
- 23 Jan 2023
- Conditions
- Myelodysplastic Syndromes · Chronic Myelomonocytic Leukemia
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 1
A Phase I Pilot Study of Abaloparatide + Bevacizumab in Myelodysplastic Syndromes
NCT0374604114 Feb 2019 to 6 Jun 2022
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- abaloparatideDrug
- bevacizumabDrug
Arms1
Experimental
abaloparatide and bevacizumab treatment
In cycle 1, patients will be treated with single-agent, subcutaneous (SQ) abaloparatide at a dose of 80 mcg/day for 28 days. In cycles 2-4 (each cycle is 28 days), patients will be treated with SQ abaloparatide at a dose of 80 mcg/day and intravenous (IV) bevacizumab 5 mg/kg on days 1 and 15.
Primary outcomes1
Outcomes the sponsor listed as primary.
Proportion of patients who experience a therapy-limiting Toxicity (TLT)
Time frame · 7 months
Registry description
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.
Secondary outcomes(1)
Proportion of patients who responded to therapy
Time frame · 7 months
Registry description
In this study, patients who have achieved complete remission (CR), partial remission (PR), marrow CR, and/or hematologic improvement will be considered responders according to the International Working Group (IWG) Response Criteria and Modified IWG Response Criteria for Hematological Improvement. The overall rate of response will be estimated among all subjects who received at least one dose of any study drug.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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