Status:
TERMINATED
Evaluation of Ruxolitinib in Combination With PU-H71 for Treatment of Myelofibrosis
Lead Sponsor:
Samus Therapeutics, Inc.
Conditions:
Myelofibrosis
Primary Myelofibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a multicenter 2-part, Phase 1b study designed to assess the safety, tolerability, pharmacokinetics (PK) and preliminary efficacy of PU-H71 in subjects taking concomitant ruxolitinib. The first...
Detailed Description
This is a multicenter 2-part, Phase 1b study designed to assess the safety, tolerability, PK and preliminary efficacy of PU-H71 (dihydrochloride salt) in subjects taking concomitant ruxolitinib. The f...
Eligibility Criteria
Inclusion
- Subject has a confirmed diagnosis of myelofibrosis, including PMF, post-PV MF, and post-ET MF.
- Subject has been receiving ruxolitinib therapy for intermediate or high-risk myelofibrosis for \>6 months prior to enrollment with no more than 1 dose reduction of ruxolitinib in the 2-8 weeks prior to enrollment and a stable daily dose ≥5 mg twice daily (BID) \>2 months prior to enrollment.
- Subject has MF with evidence of persistent disease despite ruxolitinib monotherapy treatment, consisting of:
- Persistent or worsening disease-related symptoms, including but not limited to fatigue, pruritus, night sweats, early satiety, and other symptoms as determined by a MPN-SAF TSS score of \>20 points; AND
- Documented splenomegaly of at least 5 cm below the costal margin as measured on inspiration by physical exam.
- Subject has an Eastern Cooperative Oncology Group performance status of 0-2.
- Acceptable pre-study organ function during screening defined as:
- Absolute neutrophil count (ANC) ≥ 1000/uL
- Hemoglobin (hgb) ≥ 8.0 g/dL (may be supported with transfusion)
- Platelets (plt) ≥ 75,000/uL
- AST/SGOT and ALT/SGPT ≤2 x Upper Limit of Normal (ULN)
- Direct serum bilirubin ≤ 1.5 x ULN
- Creatinine clearance \>50 mL/min/1.73 m2 based on Cockcroft Gault equation.
Exclusion
- Subject has known active liver disease, including viral hepatitis or cirrhosis.
- Subject has known or suspected HIV or other active infections requiring acute or chronic treatment with systemic antibiotics. Conditions requiring topical antibiotics are acceptable.
- Subject has a QTcF \> 480 ms (corrected) in the screening or baseline ECG.
- Subject has left ventricular ejection fraction (LVEF) ≤ 50%, or below institution's lower limit of normal (whichever is lower) by echocardiogram (ECHO) or multigated acquisition (MUGA) scan.
- Subject has a history (or family history) of long QT syndrome.
- Subject has coronary artery disease with an ischemic event within 6 months prior to enrollment.
- Subject has a permanent cardiac pacemaker.
- Subject has history of a second primary malignancy within the past 2 year except for the following (if appropriately treated and considered cured): stage I endometrial, surgically treated cervical or prostate carcinoma, and non-melanoma skin cancer.
- Subject has significant uncontrolled medical condition within 6 months prior to enrollment, as determined by the investigator.
- Subject has concurrent participation in any interventional studies within 14 days of first dose of study drug.
- Subject has uncontrolled diabetes mellitus, in the judgment of the Principal Investigator.
- Subject has an active ocular condition that in the opinion of the investigator may alter visual acuity during the course of the study (i.e., ocular inflammatory disease etc.) or a history or anticipation of major ocular surgery (including cataract extraction, intraocular surgery, etc.) during the study.
Key Trial Info
Start Date :
May 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2020
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03373877
Start Date
May 24 2018
End Date
March 10 2020
Last Update
November 15 2022
Active Locations (10)
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1
Yale Cancer Center
New Haven, Connecticut, United States, 06511
2
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
3
University of Michigan
Ann Arbor, Michigan, United States, 48109
4
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201