MPN-RC 118 AVID200 in Myelofibrosis (NCT03895112) | Clinical Trial Compass
CompletedPhase 1
MPN-RC 118 AVID200 in Myelofibrosis
United States21 participantsStarted 2019-02-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Treatment for ≥3 months with inadequate efficacy response defined as \<10% spleen volume reduction by MRI or \<30% decrease from baseline in spleen length by physical examination or regrowth to these parameters following an initial response; and/or
✓. Treatment for ≥28 days complicated by either
✓. ALT (SGPT) and/or AST (SGOT) ≤ 3x upper limit of normal (ULN), or ≤ 4 x ULN (if upon judgment of the treating physician, it is believed to be due to extramedullary hematopoiesis \[EMH\] related to MF);
✓. Direct bilirubin ≤ 1.5 x ULN; or ≤ 2x ULN (if upon judgment of the treating physician, it is believed to be due to extra-medullary hematopoiesis related to MF or documented Gilbert's syndrome);
✓. Serum creatinine ≤ 2.0 mg/dL;
✓. Platelet count ≥25 x 109/L
Exclusion criteria
✕. have the presence of cardiac disease, including a myocardial infarction within 6 months prior to study entry, unstable angina pectoris, New York Heart Association Class III/IV congestive heart failure, or uncontrolled hypertension
What they're measuring
1
Maximally tolerated dose (MTD) of AVID200
Timeframe: After 6 cycles (Each cycle is 21 days)
2
Number of patients with response eligibility for Phase 1b