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Trial record 16 of 234 for:    "Polycythemia vera"

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
+JAK2V61F Mutation

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


Participant Flow:   Overall Study
    +JAK2V61F Mutation
STARTED   5 
COMPLETED   3 
NOT COMPLETED   2 
Adverse Event                2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
patients diagnosed with JAK2V617F-positive PV

Reporting Groups
  Description
+JAK2V61F Mutation

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


Baseline Measures
   +JAK2V61F Mutation 
Overall Participants Analyzed 
[Units: Participants]
 5 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      1  20.0% 
>=65 years      4  80.0% 
Age 
[Units: Years]
Median (Full Range)
 63 
 (26 to 78) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      2  40.0% 
Male      3  60.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   5 


  Outcome Measures

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

2.  Secondary:   Toxicity   [ Time Frame: First assessment at day 15, subsequent assessments at 28 day intervals for an average of 1 year ]

3.  Secondary:   Improvement in Splenomegaly Size   [ Time Frame: 4 months, end of treatment and 12 months end of treatment ]

4.  Secondary:   Decrease of Mutant JAK2V617F Allele Burden   [ Time Frame: every 2 months until end of treatment and 12 months after end of treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: sharon-ross@ouhsc.edu



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