- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01193699
Safety Study of Pegylated Interferon Alpha 2b to Treat Polycythemia Vera (PEGINVERA)
January 29, 2018 updated by: AOP Orphan Pharmaceuticals AG
An Open-label, Prospective, Multicentre, Phase I/II Dose Escalation Study to Determine the Maximum Tolerated Dose and to Assess the Safety and Efficacy of P1101, PEG-Proline-Interferon Alpha-2b in Patients With Polycythaemia Vera
The purpose of this study is the identification of the maximum tolerated dose (MTD) of the investigational medicinal product.
Moreover the safety and tolerability will be assessed and an exploratory analysis of efficacy and biomarker modulation will be performed.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
24
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Salzburg, Austria, 5020
-
Vienna, Austria, 1090
-
Vienna, Austria, 1220
-
Vienna, Austria, 1140
-
-
Tirol
-
Innsbruck, Tirol, Austria, 6020
-
-
Upper Austria
-
Wels, Upper Austria, Austria, 4600
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Written informed consent obtained prior to any study specific screening activities and able to comply with this protocol.
- Patients age ≥18 years
- Confirmed diagnosis of PV according to either the WHO criteria (2008, appendix 6) or the PSVG (appendix 7) criteria plus JAK-2 positivity, including newly diagnosed, pre-treated and on cytoreductive therapy.
- Eastern Cooperative Oncology Group performance status ≤ 2
- If female of childbearing potential - have a negative urine pregnancy test result within 7 days prior to the scheduled first application of investigational product and agree to employ adequate birth control measures for the duration of the study.
Exclusion criteria:
- Diagnosis of any other myeloproliferative disorder
- Any clinically significant illness or surgery within 4 weeks prior to dosing
- Systemic infections, e.g. hepatitis B, hepatitis C, or HIV at screening
- Uncontrolled hypertension (systolic > 150 mmHg and diastolic > 100 mmHg, or clinically significant (i.e. active) cardiovascular disease: CVA/stroke (≤ 3 months prior to enrolment), myocardial infarction (≤ 3 months prior to enrolment), significant coronary artery stenosis, unstable angina, New York Heart Association (NYHA) Class 2 or greater Congestive heart failure, or serious cardiac arrhythmia requiring medication.
- Previous treatment with Interferon for PV
- Concurrent treatment with cytoreductive agents other than Hydroxyurea and investigational agents of any type
- History of malignant disease, including solid tumours and haematological malignancies (except basal cell and squamous cell carcinomas of the skin and carcinoma in situ of the cervix that have been completely excised and are considered cured) within the last 3 years
- History of severe allergic (like anaphylaxis) or hypersensitivity reactions (like angioedema), any known or suspected intolerance to the investigational product.
- Use of any investigational drug or participation in any investigational drug study within the last 4 weeks
- Clinically significant history or known presence of psychiatric disorders, including but not limited to depression, anxiety and sleep disorders
- Organ transplant, past or planned
- Inadequate liver function defined by serum (total) bilirubin > 2,5 x ULN and/ or AST and ALT > 2,5 x ULN
- Clinically significant ECG findings
- History of renal disease requiring haemodialysis or seizure disorder requiring anticonvulsant therapy
- Pregnant or lactating females (pregnancy test to be assessed within 7 days prior to study treatment start)
- Acute or chronic infections or autoimmune diseases (collagen diseases, polyarthritis, immune thrombocythemia, thyroiditis, psoriasis, lupus nephritis or any other autoimmune disorder).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: P1101
|
µg (starting with 50 µg), subcutaneously, 2-weekly administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum tolerated dose (MTD)
Time Frame: The incidence of dose limiting toxicities (DLTs), which define the MTD are assessed continously until achievement of MTD.
|
The definition of MTD is based on a 3+3 dose escalation design.
MTD is defined as the next lower dose of that dose which was considered to be untolerated (observed DLT frequency at least 2 out of 3 in one cohort or at least 2 out of six patients in 2 cohorts).
|
The incidence of dose limiting toxicities (DLTs), which define the MTD are assessed continously until achievement of MTD.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Barbara Grohmann-Izay, MD, AOP Orphan Pharmaceuticals AG
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2010
Primary Completion (Actual)
January 25, 2018
Study Completion (Actual)
January 25, 2018
Study Registration Dates
First Submitted
September 1, 2010
First Submitted That Met QC Criteria
September 1, 2010
First Posted (Estimate)
September 2, 2010
Study Record Updates
Last Update Posted (Actual)
January 30, 2018
Last Update Submitted That Met QC Criteria
January 29, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P11012010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Polycythemia Vera
-
PharmaEssentia Japan K.K.RecruitingPolycythemia Vera (PV)Japan
-
Novartis PharmaceuticalsCompletedPolycythemia Vera (PV)United States
-
PharmaEssentia Japan K.K.Recruiting
-
PharmaEssentia Japan K.K.CompletedPolycythemia Vera (PV)Japan
-
Memorial Sloan Kettering Cancer CenterEli Lilly and Company; Incyte CorporationRecruitingMyelofibrosis Due to and Following Polycythemia VeraUnited States
-
Ionis Pharmaceuticals, Inc.RecruitingPhlebotomy Dependent Polycythemia VeraUnited States, Canada, Hungary, United Kingdom, Australia, Poland
-
Northwestern UniversityNational Cancer Institute (NCI); Celgene; The Leukemia and Lymphoma SocietyWithdrawnPrimary Myelofibrosis | Polycythemia Vera, Post-Polycythemic Myelofibrosis PhaseUnited States
-
Novartis PharmaceuticalsTerminatedPrimary Myelofibrosis | Post-Polycythemia Vera | Post-Essential ThrombocytopeniaUnited States
-
CelgeneRecruitingPrimary Myelofibrosis | Myeloproliferative Disorders | Anemia | Myelofibrosis | Post-Polycythemia Vera MyelofibrosisFrance, Belgium, Austria, Spain, Australia, Canada, Japan, United States, Korea, Republic of, Romania, Israel, Italy, China, Czechia, Germany, Greece, Ireland, Poland, United Kingdom, Hong Kong, Hungary, Lebanon, Colombia, Argentina, Chile and more
-
CelgeneImpact Biomedicines, Inc., a wholly owned subsidiary of Celgene CorporationActive, not recruitingPrimary Myelofibrosis | Myelofibrosis | Post-Polycythemia VeraAustralia, Austria, Belgium, China, Czechia, France, Germany, Hungary, Italy, Korea, Republic of, Netherlands, Poland, Russian Federation, Spain, Ireland, United Kingdom
Clinical Trials on PEG-P-INF alpha-2b (P1101)
-
Mayo ClinicNational Cancer Institute (NCI)Active, not recruitingPrimary Myelofibrosis | Secondary MyelofibrosisUnited States
-
AOP Orphan Pharmaceuticals AGPharmaEssentia (Co-Sponsor for USA)CompletedPolycythemia VeraSpain, Belgium, Austria, Italy, Bulgaria, Czech Republic, France, Germany, Hungary, Poland, Romania, Russian Federation, Slovakia, Ukraine
-
Arbeitsgemeinschaft medikamentoese TumortherapieAOP Orphan Pharmaceuticals AGCompletedChronic Phase Chronic Myeloid LeukemiaAustria
-
Brooke Army Medical CenterT.R.U.E. Research FoundationCompleted
-
Peking University People's HospitalUnknown
-
Peking University People's HospitalUnknown
-
PharmaEssentiaCompletedChronic Hepatitis C Virus InfectionKorea, Republic of, Taiwan, China
-
M.D. Anderson Cancer CenterSchering-PloughTerminatedLeukemia, Myeloid, Philadelphia-PositiveUnited States
-
Biolex Therapeutics, Inc.Completed
-
Ain Shams UniversitySchering-Plough; Tempus Labs; Fulbright; International Society for Infectious DiseasesCompleted