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Report for Clinical Trial NCT01038856
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
The primary objective of this study is to determine the overall response rate to erlotinib in
patients with polycythemia vera (PV). Response rate will be assessed by improvement in the
complete blood count, ultrasound of the spleen, and JAK2 molecular status. It is purposed in
this study to explore a possible molecular targeting of the driving mechanism of PV.
Name: Erlotinib
Description: Erlotinib supplied as tablets; oral dose of erlotinib of 150 mg daily to be continued for 16 weeks. Responders will continue for up to 12 months, non-responders will cease taking erlotinib
Type: Drug
Group Labels: 1 +JAK2V61F mutation
Primary Outcomes
Measure: Overall Response Rate to Include Complete Hematological Response, Complete Molecular Response, Partial Hematological Response, and Minimal Hematological Response Time: Day 15
Secondary Outcomes
Measure: Toxicity Time: First assessment at day 15, subsequent assessments at 28 day intervals for an average of 1 year
Measure: Improvement in Splenomegaly Size Time: 4 months, end of treatment and 12 months end of treatment
Measure: Decrease of Mutant JAK2V617F Allele Burden Time: every 2 months until end of treatment and 12 months after end of treatment
Purpose: Treatment
Allocation: N/A
Single Group Assignment
There is one SNP
SNPs
1 V617F
Phase II Trial of Erlotinib in Patients With JAK-2 V617F Positive Polycythemia Vera. --- V617F ---
Trial of Erlotinib in Patients With JAK-2 V617F Positive Polycythemia Vera
The primary objective of this study is to determine the overall response rate to erlotinib in
patients with polycythemia vera (PV). --- V617F ---
HPO Nodes
HPO: