Trial Outcomes & Findings for Trial of Erlotinib in Patients With JAK-2 V617F Positive Polycythemia Vera (NCT NCT01038856)

NCT ID: NCT01038856

Last Updated: 2020-08-24

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 5 participants
• Primary outcome timeframe: Day 15
• Results posted on: 2020-08-24

Participant Flow

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

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.

Participant milestones

Measure	+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
Overall Study STARTED	5
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	+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
Overall Study Adverse Event	2

Baseline Characteristics

Trial of Erlotinib in Patients With JAK-2 V617F Positive Polycythemia Vera

Baseline characteristics by cohort

Measure	+JAK2V61F Mutation n=5 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age, Continuous	63 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 15

Outcome measures

Measure	Single Arm Study n=5 Participants This was a single arm study
Overall Response Rate to Include Complete Hematological Response, Complete Molecular Response, Partial Hematological Response, and Minimal Hematological Response	0 participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Single Arm Study n=5 Participants This was a single arm study
Incidence of Toxicities	5 Participants

SECONDARY outcome

Timeframe: 4 months, end of treatment and 12 months end of treatment

Population: no improvement in spleen size

Outcome measures

Measure	Single Arm Study n=3 Participants This was a single arm study
Improvement in Splenomegaly Size	0 Participants

SECONDARY outcome

Timeframe: every 2 months until end of treatment and 12 months after end of treatment

Population: did not achieve hematological response

Outcome measures

Measure	Single Arm Study n=3 Participants This was a single arm study
Decrease of Mutant JAK2V617F Allele Burden	0 Participants

Adverse Events

+JAK2V61F Mutation

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	+JAK2V61F Mutation n=5 participants at risk 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
Gastrointestinal disorders grade 3 colitis	20.0% 1/5 • Number of events 1
Skin and subcutaneous tissue disorders grade 2 facial rash	20.0% 1/5 • Number of events 1

Other adverse events

Measure	+JAK2V61F Mutation n=5 participants at risk 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
Gastrointestinal disorders Grade 1-2 Diarrhea	100.0% 5/5 • Number of events 5
Skin and subcutaneous tissue disorders Rash	100.0% 5/5 • Number of events 5

Additional Information

Research Regulatory Specialist III

University of Oklahoma

Phone: 405-271-8777

Email: sharon-ross@ouhsc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place