A Phase I Pilot Study of Abaloparatide + Bevacizumab in Myelodysplastic Syndromes

Part of paid clinical trials in Rochester, New York.

Sponsor
University of Rochester
Study ID
NCT03746041
Phase
PHASE1
Status
Completed

Conditions

  • Chronic Myelomonocytic Leukemia
  • Myelodysplastic Syndromes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • abaloparatide — DRUG
    In cycle 1, patients will be treated with single-agent, subcutaneous (SQ) abaloparatide at a dose of 80 mcg/day for 28 days.
  • bevacizumab — DRUG
    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.

Study Details

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.

Key Dates

First listed
Nov 19, 2018
Start date
Feb 14, 2019
Status verified
Jan 2023
Primary completion
Apr 1, 2022
Completion
Jun 6, 2022

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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 Outcome Measure

Proportion of patients who experience a therapy-limiting Toxicity (TLT) [ Time Frame: 7 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of RochesterRochesterNew York14623-

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By research site
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