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

Herlev Hospital, Dept. of Haematology (L121)0 个研究点目标入组 10 人开始时间: 2008年1月15日最近更新: 2012年3月19日

试验速览

暂无简介。

•- 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

•- 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

发起方

Herlev Hospital, Dept. of Haematology (L121)