Trial of Erlotinib in Patients With JAK-2 V617F Positive Polycythemia Vera

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
University of Oklahoma
Study ID
NCT01038856
Phase
PHASE2
Status
Terminated

Conditions

  • Polycythemia Vera

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib — DRUG
    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

Study Details

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.

Key Dates

First listed
Dec 24, 2009
Start date
Dec 31, 2009
Status verified
Aug 2020
Primary completion
Dec 31, 2012
Completion
Feb 28, 2014

Study Design

Enrollment
5 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: +JAK2V61F mutation
    Patients with MPN diagnoses and polycythemia vera who also have a confirmed JAK2V617F mutation

Primary Outcome Measure

Overall Response Rate to Include Complete Hematological Response, Complete Molecular Response, Partial Hematological Response, and Minimal Hematological Response [ Time Frame: Day 15 ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-

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By research site
University of Oklahoma Health Sciences Center· Oklahoma City, OK

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