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Tyrosine Kinase Inhibitor

Trial of Erlotinib in Patients With JAK-2 V617F Positive Polycythemia Vera (OSI-TAR-766 Trial)

Phase 2
Waitlist Available
Led By Mohamad Cherry, MD
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* WHO 2008 diagnosis of Polycythemia Vera Hemoglobin \> 18.5 g/dl for men (16.5 g/dl for women) and presence of JAK2V617F mutation and either bone marrow trilineage myeloproliferation or subnormal serum erythropoietin level Patients may be on active treatment (phlebotomy, aspirin) ECOG performance status 0,1,2,or 3 Adequate hepatic function, adequate renal function
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first assessment at day 15, subsequent assessments at 28 day intervals for an average of 1 year
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group

Summary

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.

Eligible Conditions
  • Polycythemia Vera

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first assessment at day 15, subsequent assessments at 28 day intervals for an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and first assessment at day 15, subsequent assessments at 28 day intervals for an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Incidence of Toxicities

Side effects data

From 2014 Phase 4 trial • 45 Patients • NCT02000531
29%
Nausea
19%
Leukopenia
14%
Anaemia
14%
White blood cell count decreased
14%
Vomiting
14%
Neutropenia
14%
Thrombocytopenia
14%
Alanine aminotransferase increased
10%
Neutrophil count decreased
10%
Platelet count decreased
10%
Aspartate aminotransferase increased
5%
Dizziness
5%
Musculoskeletal pain
5%
Diarrhea
5%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Erlotinib-Chemotherapy
Chemotherapy-Erlotinib

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: +JAK2V61F mutationExperimental Treatment1 Intervention
Patients with MPN diagnoses and polycythemia vera who also have a confirmed JAK2V617F mutation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Erlotinib
FDA approved

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor
474 Previous Clinical Trials
93,686 Total Patients Enrolled
OSI PharmaceuticalsIndustry Sponsor
72 Previous Clinical Trials
5,995 Total Patients Enrolled
Mohamad Cherry, MDPrincipal InvestigatorUniversity of Oklahoma
~0 spots leftby Jan 2026
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