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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01038856
Recruitment Status : Terminated (The study was terminated by the sponsor)
First Posted : December 24, 2009
Results First Posted : February 7, 2018
Last Update Posted : August 24, 2020
Sponsor:
Collaborator:
OSI Pharmaceuticals
Information provided by (Responsible Party):
University of Oklahoma

Study Description
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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.

Condition or disease Intervention/treatment Phase
Polycythemia Vera Drug: Erlotinib Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Erlotinib in Patients With JAK-2 V617F Positive Polycythemia Vera
Study Start Date : December 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : February 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: +JAK2V61F mutation
Patients with MPN diagnoses and polycythemia vera who also have a confirmed JAK2V617F mutation
 Drug: Erlotinib
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
Other Names:
  • Tarceva
  • OSI-744


Outcome Measures
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Primary Outcome Measures :
  1. Overall Response Rate to Include Complete Hematological Response, Complete Molecular Response, Partial Hematological Response, and Minimal Hematological Response [ Time Frame: Day 15 ]

Secondary Outcome Measures :
  1. Incidence of Toxicities [ Time Frame: First assessment at day 15, subsequent assessments at 28 day intervals for an average of 1 year ]
    Grade 3 or grade 4 toxicities as measured by CTCAE v3.0

  2. Improvement in Splenomegaly Size [ Time Frame: 4 months, end of treatment and 12 months end of treatment ]
  3. Decrease of Mutant JAK2V617F Allele Burden [ Time Frame: every 2 months until end of treatment and 12 months after end of treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01038856


Locations
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United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
OSI Pharmaceuticals
Investigators
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Principal Investigator: Mohamad Cherry, MD University of Oklahoma
More Information
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Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT01038856    
Other Study ID Numbers: 2249
First Posted: December 24, 2009    Key Record Dates
Results First Posted: February 7, 2018
Last Update Posted: August 24, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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Polycythemia Vera
Polycythemia
Hematologic Diseases
Bone Marrow Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Neoplasms
 Bone Marrow Diseases
Myeloproliferative Disorders
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action