Polycythaemia Vera & Essential Thrombocythaemia MedDRA version: 9.1 Level: LLT Classification code 10015494 Term: Essential thrombocythemia MedDRA version: 9.1 Level: LLT Classification code 10036061 Term: Polycythemia vera
Conditions
Interventions
Trade Name: Tarceva
Pharmaceutical Form: Tablet
INN or Proposed INN: ERLOTINIB
Sponsors
Herlev Hospital, Dept. of Haematology (L121)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and efficacy of erlotinib in the treatment of patients with JAK2-positive polycythaemia vera (PV) and essential thrombocythaemia (ET). To evaluate if erlotinib as monotherapy for patients with JAK2-positive PV and ET is followed by a decline in clonal myeloproliferation as assessed by conventional disease activity parameters (a decrease in the need of phlebotomy (PV), leucocyte and platelet count) To study if treatment with erlotinib influcences the JAK2 mutation status as assessed by quantitative PCR;Secondary Objective: To perform integrated gene expression (global and focused) profiling and proteome studies (serum-based and phosphoproteomics) before and during treatment with erlotinib in order to describe in detail the various (heterogenous) response patterns at the molecular level. To study changes in bone marrow morphology before and after treatment with erlotinib. To study in vivo granulocyte, platelet and endothelial activation before and during treatment with erlotinib.;Primary end point(s): 1) Normalisation of the haematocrit or at least >50% reduction in the need of phlebotomy 2) Platelet count 50% reduction of platelet count 3) Leucocyte count < 10 Mia/l. | — |
Countries
Denmark
Outcome results
None listed