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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01193699
Recruitment Status : Completed
First Posted : September 2, 2010
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
AOP Orphan Pharmaceuticals AG

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Polycythemia Vera Drug: PEG-P-INF alpha-2b (P1101) Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : August 2010
Actual Primary Completion Date : January 25, 2018
Actual Study Completion Date : January 25, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: P1101 Drug: PEG-P-INF alpha-2b (P1101)
µg (starting with 50 µg), subcutaneously, 2-weekly administration


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01193699


Locations
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Austria
Innsbruck, Tirol, Austria, 6020
Wels, Upper Austria, Austria, 4600
Salzburg, Austria, 5020
Vienna, Austria, 1090
Vienna, Austria, 1140
Vienna, Austria, 1220
Sponsors and Collaborators
AOP Orphan Pharmaceuticals AG
Investigators
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Study Director: Barbara Grohmann-Izay, MD AOP Orphan Pharmaceuticals AG
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AOP Orphan Pharmaceuticals AG
ClinicalTrials.gov Identifier: NCT01193699    
Other Study ID Numbers: P11012010
First Posted: September 2, 2010    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Polycythemia Vera
Polycythemia
Hematologic Diseases
Bone Marrow Neoplasms
Hematologic Neoplasms
 Neoplasms by Site
Neoplasms
Bone Marrow Diseases
Myeloproliferative Disorders