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

NCT01193699 | Completed Phase 1

• 1 other identifier: P11012010
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 6

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.

Conditions

Polycythemia Vera

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (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.

Study Arms (1)

P1101

EXPERIMENTAL

Drug: PEG-P-INF alpha-2b (P1101)

Interventions

PEG-P-INF alpha-2b (P1101) DRUG

µg (starting with 50 µg), subcutaneously, 2-weekly administration

P1101

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• AOP Orphan Pharmaceuticals AG: lead

Study Sites (6)

Unknown Facility

Innsbruck, Tyrol, 6020, Austria

Location

Unknown Facility

Wels, Upper Austria, 4600, Austria

Location

Unknown Facility

Salzburg, 5020, Austria

Location

Unknown Facility

Vienna, 1090, Austria

Location

Unknown Facility

Vienna, 1140, Austria

Location

Unknown Facility

Vienna, 1220, Austria

Location

Related Publications (1)

• Gisslinger H, Zagrijtschuk O, Buxhofer-Ausch V, Thaler J, Schloegl E, Gastl GA, Wolf D, Kralovics R, Gisslinger B, Strecker K, Egle A, Melchardt T, Burgstaller S, Willenbacher E, Schalling M, Them NC, Kadlecova P, Klade C, Greil R. Ropeginterferon alfa-2b, a novel IFNalpha-2b, induces high response rates with low toxicity in patients with polycythemia vera. Blood. 2015 Oct 8;126(15):1762-9. doi: 10.1182/blood-2015-04-637280. Epub 2015 Aug 10.

  PMID: 26261238 DERIVED

MeSH Terms

Conditions

Polycythemia Vera

Condition Hierarchy (Ancestors)

Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Myeloproliferative Disorders

Study Officials

• Barbara Grohmann-Izay, MD

  AOP Orphan Pharmaceuticals AG

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2010
• First Posted: September 2, 2010
• Study Start: August 1, 2010
• Primary Completion: January 25, 2018
• Study Completion: January 25, 2018
• Last Updated: January 30, 2018

Record last verified: 2018-01

Locations

AU (6)