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

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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 : February 7, 2018
Sponsor:
Collaborator:
OSI Pharmaceuticals
Information provided by (Responsible Party):
University of Oklahoma

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Polycythemia Vera
Intervention Drug: Erlotinib
Enrollment 5
Recruitment Details we conducted a single arm, prospective phase II study at the University of Oklahoma Health Sciences Center and the Oklahoma City VA hospitals in patients withWHO-defined JAK2V617F-positive PV from June 2010 to August 2012
Pre-assignment Details Patients were eligible for the study if they were at least 18 years of age and had a diagnosis of PV per WHO 2008 criteria. Additional eligibility criteria included adequate liver and kidney function tests and an ECOG performance status of 0, 1, 2, or 3.
Arm/Group Title +JAK2V61F Mutation
Hide Arm/Group Description

Patients with MPN diagnoses and polycythemia vera who also have a confirmed JAK2V617F mutation

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

Period Title: Overall Study
Started 5
Completed 3
Not Completed 2
Reason Not Completed
Adverse Event             2
Arm/Group Title +JAK2V61F Mutation
Hide Arm/Group Description

Patients with MPN diagnoses and polycythemia vera who also have a confirmed JAK2V617F mutation

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

Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
patients diagnosed with JAK2V617F-positive PV
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
  20.0%
>=65 years
4
  80.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 5 participants
63
(26 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
2
  40.0%
Male
3
  60.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
 100.0%
1.Primary Outcome
Title Overall Response Rate to Include Complete Hematological Response, Complete Molecular Response, Partial Hematological Response, and Minimal Hematological Response
Hide Description [Not Specified]
Time Frame Day 15
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm Study
Hide Arm/Group Description:
This was a single arm study
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
0
2.Secondary Outcome
Title Toxicity
Hide Description [Not Specified]
Time Frame First assessment at day 15, subsequent assessments at 28 day intervals for an average of 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erlotinib
Hide Arm/Group Description:
150 mg po daily x 16 weeks
Overall Number of Participants Analyzed 5
Measure Type: Count of Participants
Unit of Measure: Participants
5
 100.0%
3.Secondary Outcome
Title Improvement in Splenomegaly Size
Hide Description [Not Specified]
Time Frame 4 months, end of treatment and 12 months end of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
no improvement in spleen size
Arm/Group Title +JAK2V61F Mutation
Hide Arm/Group Description:

Patients with MPN diagnoses and polycythemia vera who also have a confirmed JAK2V617F mutation

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

Overall Number of Participants Analyzed 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
4.Secondary Outcome
Title Decrease of Mutant JAK2V617F Allele Burden
Hide Description [Not Specified]
Time Frame every 2 months until end of treatment and 12 months after end of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
did not achieve hematological response
Arm/Group Title +JAK2V61F Mutation
Hide Arm/Group Description:

Patients with MPN diagnoses and polycythemia vera who also have a confirmed JAK2V617F mutation

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

Overall Number of Participants Analyzed 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title +JAK2V61F Mutation
Hide Arm/Group Description

Patients with MPN diagnoses and polycythemia vera who also have a confirmed JAK2V617F mutation

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

All-Cause Mortality
+JAK2V61F Mutation
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
+JAK2V61F Mutation
Affected / at Risk (%) # Events
Total   1/5 (20.00%)    
Gastrointestinal disorders   
grade 3 colitis   1/5 (20.00%)  1
Skin and subcutaneous tissue disorders   
grade 2 facial rash   1/5 (20.00%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
+JAK2V61F Mutation
Affected / at Risk (%) # Events
Total   5/5 (100.00%)    
Gastrointestinal disorders   
Grade 1-2 Diarrhea   5/5 (100.00%)  5
Skin and subcutaneous tissue disorders   
Rash   5/5 (100.00%)  5
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Research Regulatory Specialist III
Organization: University of Oklahoma
Phone: 405-271-8777 ext 48394
Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT01038856     History of Changes
Other Study ID Numbers: 2249
First Submitted: December 22, 2009
First Posted: December 24, 2009
Results First Submitted: May 28, 2015
Results First Posted: February 7, 2018
Last Update Posted: February 7, 2018