A Phase I Pilot Study of Abaloparatide + Bevacizumab in Myelodysplastic Syndromes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03746041|
Recruitment Status : Active, not recruiting
First Posted : November 19, 2018
Last Update Posted : January 5, 2022
|Condition or disease||Intervention/treatment||Phase|
|Myelodysplastic Syndromes Chronic Myelomonocytic Leukemia||Drug: abaloparatide Drug: bevacizumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Pilot Study of Abaloparatide + Bevacizumab in Myelodysplastic Syndromes|
|Actual Study Start Date :||February 14, 2019|
|Estimated Primary Completion Date :||April 1, 2022|
|Estimated Study Completion Date :||June 1, 2022|
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.
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.
- Proportion of patients who experience a therapy-limiting Toxicity (TLT) [ Time Frame: 7 months ]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.
- Proportion of patients who responded to therapy [ Time Frame: 7 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03746041
|United States, New York|
|University of Rochester|
|Rochester, New York, United States, 14623|
|Principal Investigator:||Jason Mendler, M.D.||University of Rochester|