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

NCT01038856 | Terminated Phase 2 Results DMC

• 1 other identifier: 2249
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycythemia Vera

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate to Include Complete Hematological Response, Complete Molecular Response, Partial Hematological Response, and Minimal Hematological Response

  Day 15

Secondary Outcomes (3)

• Incidence of Toxicities

  First assessment at day 15, subsequent assessments at 28 day intervals for an average of 1 year

• Improvement in Splenomegaly Size

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

• Decrease of Mutant JAK2V617F Allele Burden

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

Study Arms (1)

+JAK2V61F mutation

EXPERIMENTAL

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

Drug: Erlotinib

Interventions

Erlotinib DRUG

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

Also known as: Tarceva, OSI-744

+JAK2V61F mutation

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient with active malignancy Patients with clinically significant cardiac disease within 1 year Opthalmologic or gastrointestinal abnormalities Concurrent cytoreductive therapy is not allowed

Sponsors & Collaborators

• University of Oklahoma: lead
• OSI Pharmaceuticals: collaborator

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Polycythemia Vera

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Myeloproliferative Disorders

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Research Regulatory Specialist III
• Organization: University of Oklahoma

sharon-ross@ouhsc.edu

405-271-8777

Study Officials

• Mohamad Cherry, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2009
• First Posted: December 24, 2009
• Study Start: December 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: February 1, 2014
• Last Updated: August 24, 2020
• Results First Posted: February 7, 2018

Record last verified: 2020-08

Locations

US (1)