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Report for Clinical Trial NCT01038856

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Phase II 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). 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.

NCT01038856 Polycythemia Vera
MeSH:Polycythemia Vera Polycythemia
HPO:Polycythemia

1 Interventions

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: