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Safety Study of Pegylated Interferon Alpha 2b to Treat Polycythemia Vera (PEGINVERA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AOP Orphan Pharmaceuticals AG
ClinicalTrials.gov Identifier:
NCT01193699
First received: September 1, 2010
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Polycythemia Vera
Drug: PEG-P-INF alpha-2b (P1101)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AOP Orphan Pharmaceuticals AG:

Primary Outcome Measures:
  • Maximum tolerated dose (MTD) [ Time Frame: The incidence of dose limiting toxicities (DLTs), which define the MTD are assessed continously until achievement of MTD. ] [ Designated as safety issue: Yes ]
    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).


Estimated Enrollment: 24
Study Start Date: August 2010
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: P1101 Drug: PEG-P-INF alpha-2b (P1101)
µg (starting with 50 µg), subcutaneously, 2-weekly administration

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent obtained prior to any study specific screening activities and able to comply with this protocol.
  2. Patients age ≥18 years
  3. 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.
  4. Eastern Cooperative Oncology Group performance status ≤ 2
  5. 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:

  1. Diagnosis of any other myeloproliferative disorder
  2. Any clinically significant illness or surgery within 4 weeks prior to dosing
  3. Systemic infections, e.g. hepatitis B, hepatitis C, or HIV at screening
  4. 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.
  5. Previous treatment with Interferon for PV
  6. Concurrent treatment with cytoreductive agents other than Hydroxyurea and investigational agents of any type
  7. 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
  8. History of severe allergic (like anaphylaxis) or hypersensitivity reactions (like angioedema), any known or suspected intolerance to the investigational product.
  9. Use of any investigational drug or participation in any investigational drug study within the last 4 weeks
  10. Clinically significant history or known presence of psychiatric disorders, including but not limited to depression, anxiety and sleep disorders
  11. Organ transplant, past or planned
  12. Inadequate liver function defined by serum (total) bilirubin > 2,5 x ULN and/ or AST and ALT > 2,5 x ULN
  13. Clinically significant ECG findings
  14. History of renal disease requiring haemodialysis or seizure disorder requiring anticonvulsant therapy
  15. Pregnant or lactating females (pregnancy test to be assessed within 7 days prior to study treatment start)
  16. Acute or chronic infections or autoimmune diseases (collagen diseases, polyarthritis, immune thrombocythemia, thyroiditis, psoriasis, lupus nephritis or any other autoimmune disorder).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01193699

Locations
Austria
Innsbruck, Tirol, Austria, 6020
Wels, Upper Austria, Austria, 4600
Salzburg, Austria, 5020
Vienna, Austria, 1140
Vienna, Austria, 1220
Vienna, Austria, 1090
Sponsors and Collaborators
AOP Orphan Pharmaceuticals AG
Investigators
Study Director: Oleh Zahriychuk, MD AOP Orphan Pharmaceuticals AG
  More Information

No publications provided

Responsible Party: AOP Orphan Pharmaceuticals AG
ClinicalTrials.gov Identifier: NCT01193699     History of Changes
Other Study ID Numbers: P11012010
Study First Received: September 1, 2010
Last Updated: February 6, 2014
Health Authority: Austria: Federal Office for Safety in Health Care

Additional relevant MeSH terms:
Polycythemia
Polycythemia Vera
Bone Marrow Diseases
Hematologic Diseases
Myeloproliferative Disorders
Interferon-alpha
Peginterferon alfa-2b
Anti-Infective Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014