Back to resultsTrial of Erlotinib in Patients With JAK-2 V617F Positive Polycythemia Vera (OSI-TAR-766)
Primary Purpose
Polycythemia Vera
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Erlotinib
Sponsored by
About this trial
This is an interventional treatment trial for Polycythemia Vera
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patient with active malignancy Patients with clinically significant cardiac disease within 1 year Opthalmologic or gastrointestinal abnormalities Concurrent cytoreductive therapy is not allowed
Sites / Locations
- University of Oklahoma Health Sciences Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
+JAK2V61F mutation
Arm Description
Patients with MPN diagnoses and polycythemia vera who also have a confirmed JAK2V617F mutation
Outcomes
Primary Outcome Measures
Overall Response Rate to Include Complete Hematological Response, Complete Molecular Response, Partial Hematological Response, and Minimal Hematological Response
Secondary Outcome Measures
Incidence of Toxicities
Grade 3 or grade 4 toxicities as measured by CTCAE v3.0
Improvement in Splenomegaly Size
Decrease of Mutant JAK2V617F Allele Burden
Full Information
NCT ID
NCT01038856
First Posted
December 22, 2009
Last Updated
August 7, 2020
Sponsor
University of Oklahoma
Collaborators
OSI Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01038856
Brief Title
Trial of Erlotinib in Patients With JAK-2 V617F Positive Polycythemia Vera
Acronym
OSI-TAR-766
Official Title
Phase II Trial of Erlotinib in Patients With JAK-2 V617F Positive Polycythemia Vera
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated by the sponsor
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
Collaborators
OSI Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
This is a phase II open-label study. Patients will be screened for MPN diagnoses and patients with Polycythemia vera proven to have JAK2V617F mutation will be given the option to enroll. Consenting patients will take erlotinib daily for 16 weeks. Blood work and pharmacokinetics will be drawn for serum level monitoring. Doses will be administered according to side effects or held. First assessment will be at day 15 wth subsequent assessments at 28 day intervals. Non-responders will be taken off the study and managed according to standard of care. Patients who do respond will continue taking the therapy for a total of 12 months. Observation will be for a total of 12 months after finishing treatment. In addition to the clinical aspect of this study, there will be correlative studies where molecular response will be checked and its correlation with clinical response.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycythemia Vera
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
+JAK2V61F mutation
Arm Type
Experimental
Arm Description
Patients with MPN diagnoses and polycythemia vera who also have a confirmed JAK2V617F mutation
Intervention Type
Drug
Intervention Name(s)
Erlotinib
Other Intervention Name(s)
Tarceva, OSI-744
Intervention 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
Primary Outcome Measure Information:
Title
Overall Response Rate to Include Complete Hematological Response, Complete Molecular Response, Partial Hematological Response, and Minimal Hematological Response
Time Frame
Day 15
Secondary Outcome Measure Information:
Title
Incidence of Toxicities
Description
Grade 3 or grade 4 toxicities as measured by CTCAE v3.0
Time Frame
First assessment at day 15, subsequent assessments at 28 day intervals for an average of 1 year
Title
Improvement in Splenomegaly Size
Time Frame
4 months, end of treatment and 12 months end of treatment
Title
Decrease of Mutant JAK2V617F Allele Burden
Time Frame
every 2 months until end of treatment and 12 months after end of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Patient with active malignancy Patients with clinically significant cardiac disease within 1 year Opthalmologic or gastrointestinal abnormalities Concurrent cytoreductive therapy is not allowed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamad Cherry, MD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Trial of Erlotinib in Patients With JAK-2 V617F Positive Polycythemia Vera
We'll reach out to this number within 24 hrs