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NCT03895112 · ClinicalTrials.gov registry record · Phase 1
MPN-RC 118 AVID200 in Myelofibrosis
A Phase 1 study of Primary Myelofibrosis and Post-Essential Thrombocythemia Myelofibrosis, sponsored by John Mascarenhas.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT03895112 is a Phase 1 study of Primary Myelofibrosis and Post-Essential Thrombocythemia Myelofibrosis that has completed, run by John Mascarenhas. The registered enrollment target is 21 participants, below the 120-participant average among 30 other Primary Myelofibrosis trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03895112, a Phase 1 study of Primary Myelofibrosis and Post-Essential Thrombocythemia Myelofibrosis, has completed, sponsored by John Mascarenhas.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
Increased levels of TGF-β1 were detected in serum, plasma and BM and positively correlated with both grade of BMF and extent of leukemic cell infiltration in the marrow. TGF-β likely plays a dual role in promoting myelofibrosis and myeloproliferation, both of which are the bone marrow morphologic hallmark of MF. AVID200 is a drug that targets TGF-β1 and TGF-β3. The study team hypothesizes that inhibiting the TGF-β signaling pathway in MF will decrease the fibrogenic stimuli leading to myelofibrosis and concomitantly interrupt myeloproliferation and restore normal hematopoiesis. This is a first in human, open-label, multicenter, Phase I/Ib trial of AVID200. Patients must have intermediate-2 or higher primary myelofibrosis (PMF), post-essential thrombocythemia or polycythemia-vera related MF (Post ET/PV MF). This study will enroll up to 24 patients. AVID200 is delivered by IV infusion on day 1 of each 3 week cycle.
Conditions Studied
Interventions
- DRUG AVID200
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2019-02-15 |
| Est. Completion | 2022-05-16 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03895112
The ClinicalTrials.gov registry entry for NCT03895112 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 120-participant average among 30 other Primary Myelofibrosis trials with a reported enrollment target (82% lower). The listed sponsor is John Mascarenhas, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Primary Myelofibrosis appearing as the primary indexed condition, and to 1 intervention - of which AVID200 is the first listed.
NCT03895112 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT03895112 about?
NCT03895112 is a clinical study titled "MPN-RC 118 AVID200 in Myelofibrosis". Increased levels of TGF-β1 were detected in serum, plasma and BM and positively correlated with both grade of BMF and extent of leukemic cell infiltration in the marrow. TGF-β likely plays a dual role in promoting myelofibrosis and myeloproliferation, both of which are the bone marrow morphologic ha...
What is the current status of trial NCT03895112?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2019-02-15. Estimated completion is 2022-05-16.
What conditions does trial NCT03895112 study?
This clinical trial studies the following conditions: Primary Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Post-PV MF, Post ET MF.
What interventions are being tested in trial NCT03895112?
The interventions under investigation include: AVID200 (DRUG).
Who is sponsoring clinical trial NCT03895112?
This trial is sponsored by John Mascarenhas, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03895112 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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