A Phase II Study of Erlotinib in Patients with Polycythaemia Vera and Essential Thrombocythemia

• Conditions: Polycythaemia Vera & Essential Thrombocythaemia; MedDRA version: 9.1Level: LLTClassification code 10015494Term: Essential thrombocythemia; MedDRA version: 9.1Level: LLTClassification code 10036061Term: Polycythemia vera

• Registration Number: EUCTR2007-007335-99-DK
• Lead Sponsor: Herlev Hospital, Dept. of Haematology (L121)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

- Male or female patient > 18 years of age
- A confirmed diagnosis of JAK2-positive PV and ET (according to the Nordic
Guidelines)
- Biochemical evidence of active disease as defined by
a) A need for phlebotomy within the last 3 months
b) A leucocyte count > 10 Mia/l in the absence of infection or inflammation (normal
CRP) (PV/ET)
c) A platelet count > 400 Mia/l in the absence of infection or inflammation (normal
CRP) (PV/ET)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- A platelet count > 1000 Mia/l (a need for cytoreduction in platelet count)
- Patients of childbearing potential without a negative pregnancy test prior to
initiation of study drug
- ECOG Performance Status Score >/= 3
- Serum creatinine more than 2 x's the ULN
- Total serum bilirubine more than 1.5 x's the ULN
- Plasma ASAT/ALAT more than 3 x's the ULN
- Interpheron alpha within 1 week of day 1
- Hydroxyurea within 1 week of day 1
- Anagrelide within 1 week of day 1
- Any other investigational drug within 28 days of day 1
- Grade 3/4 cardiac disease
- Any serious concomitant disease

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified