Myeloproliferative Neoplasms Clinical Trial

A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of P1101 in Adults With ET

Summary

A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Ropeginterferon alfa-2b-njft (P1101) in Adult Patients with Essential Thrombocythemia

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Full Description

PharmaEssentia is developing a pegylated (PEG) IFN-α product, P1101, for the treatment of Essential Thrombocythemia (ET) as lack of disease modifying therapies in essential ET constitutes a serious issue in modern hematology.

Ropeginterferonalfa-2b-njft (P1101) may represent an effective, well-tolerated treatment with the ability to provide a deeper response and superior control of important blood parameters with the potential to alter the course of the disease and prevent progression to post-ET myelofibrosis (MF) and/or secondary acute myeloid leukemia (sAML). Ropeginterferon alfa-2b-njft (P1101) is currently being evaluated in comparison to ANA in the ongoing global Phase 3 clinical study, SURPASS ET..

Enrolled patients will receive P1101 over 13 months followed by an extension period.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Male and female subjects ≥18 years old.
Subjects diagnosed with ET according to the World Health Organization (WHO) 2016 criteria.
Subjects that are cytoreductive treatment-naïve, or pre-exposed to HU and/or ANA, as specified below (according to Investigator's judgment and documented in the patient's medical record):
Interferon treatment-naïve.
Adequate hepatic function defined as bilirubin ≤1.5 × upper limit normal (ULN), prothrombin time (PT) (international normalized ratio, [INR]) ≤1.5 x ULN, albumin >3.5 g/dL, alanine aminotransferase (ALT) ≤2.0 x ULN, aspartate aminotransferase ≤2.0 x ULN at screening.
Creatinine clearance ≥40 mL/min (by Cockcroft-Gault equation).
Males and females of childbearing potential, as well as all women <2 years after the onset of menopause, must agree to use an acceptable form of birth control until 60 days following the last dose of the study drug, and females must agree to not breastfeed during the study.
Written informed consent obtained from the subject and ability for the subject to comply with the requirements of the study.
Platelet count >450 × 109/L at screening

Exclusion Criteria:

Any subject requiring a legally authorized representative
Any contraindications or hypersensitivity to IFN-α and/or its excipients
Co-morbidity with severe or serious condition that, in the Investigator's opinion, would jeopardize the safety of the subject or their compliance with the protocol, including significant cardiac disease (including New York Heart Association Class III-IV congestive heart failure and clinically significant arrhythmias) and pulmonary hypertension
History of major organ transplantation
Pregnant or lactating females
Subjects with any significant medical conditions that, in the opinion of the Investigator, would compromise the results of the study or may impair compliance with the requirements of the protocol, including but not limited to:
Use of any investigational drug <4 weeks prior to the first dose of study drug or not recovered from effects of prior administration of any investigational agent
Presence of more than one driver mutation (e.g., V617F JAK2 and CALR, CALR and MPL, V617F JAK2 and MPL)
Prior use of Ruxolitinib

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 2

Estimated Enrollment:

64

Study ID:

NCT05482971

Recruitment Status:

Recruiting

Sponsor:

PharmaEssentia

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There are 23 Locations for this study

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University of Alabama at Birmingham
Birmingham Alabama, 35294, United States More Info
Zachary Prutch
Contact
800-999-2449
[email protected]
Marin Cancer Care
Greenbrae California, 94904, United States More Info
Zachary Prutch
Contact
800-999-2449
[email protected]
Yale University School of Medicine - Yale Cancer Center
New Haven Connecticut, 06510, United States More Info
Zachary Prutch
Contact
800-999-2449
[email protected]
Georgetown University Medical Center
Washington District of Columbia, 20057, United States More Info
Zachary Prutch
Contact
800-999-2449
[email protected]
The Winship Cancer Institute Emory University
Atlanta Georgia, 30322, United States More Info
Zachary Prutch
Contact
800-999-2449
[email protected]
Tulane University Medical Center
New Orleans Louisiana, 70112, United States More Info
Zachary Prutch
Contact
800-999-2449
[email protected]
Massachusetts General
Boston Massachusetts, 02114, United States More Info
Zachary Prutch
Contact
800-999-2449
[email protected]
Washington University School of Medicine - Division of Oncology
Saint Louis Missouri, 63110, United States More Info
Zachary Prutch
Contact
800-999-2449
[email protected]
Cancer Care Specialists
Reno Nevada, 89511, United States More Info
Zachary Prutch
Contact
800-999-2449
[email protected]
John Theurer Cancer Center At Hackensack UMC
Hackensack New Jersey, 07601, United States More Info
Zachary Prutch
Contact
800-999-2449
[email protected]
Montefiore Medical Center
Bronx New York, 10467, United States More Info
Zachary Prutch
Contact
800-999-2449
[email protected]
Weill Medical College of Cornell University
New York New York, 10021, United States More Info
Zachary Prutch
Contact
800-999-2449
[email protected]
Stony Brook University Medical Center
Stony Brook New York, 11794, United States More Info
Zachary Prutch
Contact
800-999-2449
[email protected]
University of North Carolina (UNC) - Lineberger Comprehensive Cancer Center
Chapel Hill North Carolina, 27514, United States More Info
Zachary Prutch
Contact
800-999-2449
[email protected]
Duke University Medical Center
Durham North Carolina, 27710, United States More Info
Zachary Prutch
Contact
800-999-2449
[email protected]
East Carolina University
Greenville North Carolina, 27858, United States More Info
Zachary Prutch
Contact
800-999-2449
[email protected]
Cleveland Clinic
Cleveland Ohio, 44195, United States More Info
Zachary Prutch
Contact
800-999-2449
[email protected]
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States More Info
Zachary Prutch
Contact
800-999-2449
[email protected]
University of Tennessee Health Science Center
Memphis Tennessee, 38103, United States More Info
Zachary Prutch
Contact
800-999-2449
[email protected]
MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Zachary Prutch
Contact
800-999-2449
[email protected]
University of Utah
Salt Lake City Utah, 84132, United States More Info
Zachary Prutch
Contact
800-999-2449
[email protected]
University of Virginia - Emily Couric Cancer Center
Charlottesville Virginia, 22903, United States More Info
Zachary Prutch
Contact
800-999-2449
[email protected]
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States More Info
Zachary Prutch
Contact
800-999-2449
[email protected]
St. Paul's Hospital - Providence Health Care
Vancouver British Columbia, , Canada More Info
Zachary Prutch
Contact
1-800-999-2449
[email protected]
Juravinski Cancer Centre
Hamilton Ontario, , Canada More Info
Zachary Prutch
Contact
1-800-999-2449
[email protected]
Princess Margaret Hospital
Toronto Ontario, , Canada More Info
Zachary Prutch
Contact
1-800-999-2449
[email protected]
Princess Margaret
Toronto Ontario, , Canada More Info
Zachary Prutch
Contact
+1-800-999-2449
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 2

Estimated Enrollment:

64

Study ID:

NCT05482971

Recruitment Status:

Recruiting

Sponsor:


PharmaEssentia

How clear is this clinincal trial information?

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