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Study in Patients With Primary, Post Polycythemia Vera or Post Essential Thrombocythemia Myelofibrosis

This study is not yet open for participant recruitment.
Verified November 2010 by Arresto Biosciences, Inc.
Sponsor:
Information provided by:
Arresto Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT01242709
First received: November 12, 2010
Last updated: November 17, 2010
Last verified: November 2010
History of Changes
  Purpose

The purpose of this study is to determine if AB0024 is effective in treating patients with Primary Myelofibrosis, and Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis.


Condition Intervention Phase
Primary Myelofibrosis
Post-Essential Thrombocythemia Myelofibrosis
 Drug: AB0024
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study to Evaluate the Efficacy and Safety of AB0024 in Adult Patients With Primary, Post Polycythemia Vera or Post Essential Thrombocythemia Myelofibrosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Arresto Biosciences, Inc.:

Primary Outcome Measures:
  • Using the International Working Group criteria, determine the number of patients that respond to AB0024 ater 2 cycles of treatment. [ Time Frame: After 2 Cycle = 190 days ] [ Designated as safety issue: No ]
    If no patients respond after 2 cycles, the study will be stopped.


Estimated Enrollment: 54
Study Start Date: February 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
AB0024 administered at 200mg
 Drug: AB0024
AB0024 administered at 200mg
Experimental: Cohort 2
AB0024 administered at 700mg
 Drug: AB0024
AB0024 administered at 700mg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with Primary Myelofibrosis or Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis
  • Adequate organ function
  • ECOG performance ≤ 2

Exclusion Criteria:

  • Known history of human immunodeficiency virus, hepatitis C, or hepatitis B
  • Use of any growth factors, cytotoxic chemotherapeutic agents, corticosteroids, or immunomodulators within 2 weeks and interferon use within 4 weeks prior to study Day 1.
  • History of surgery within 2 weeks prior to enrollment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01242709

Locations
United States, California
Stanford Cancer Center Not yet recruiting
Palo Alto, California, United States, 94305
Contact: Jason Gotlib, MD            
Principal Investigator: Jason Gotlib, MD            
United States, Texas
MD Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: Srdan Verstovsek, MD     713-745-3429        
Principal Investigator: Srdan Verstovsek, MD            
Sponsors and Collaborators
Arresto Biosciences, Inc.
Investigators
Study Director: Dung Thai, MD, PhD Arresto Biosciences, Inc.
  More Information

No publications provided

Responsible Party: Dung Thai, MD PhD, Arresto Biosciences
ClinicalTrials.gov Identifier: NCT01242709     History of Changes
Other Study ID Numbers: AB0024-102
Study First Received: November 12, 2010
Last Updated: November 17, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Arresto Biosciences, Inc.:
Oncology
Hematology
Myelofibrosis
Thrombocythemia Myelofibrosis

Additional relevant MeSH terms:
Primary Myelofibrosis
Polycythemia
Polycythemia Vera
Thrombocythemia, Essential
Thrombocytosis
Myeloproliferative Disorders
 Bone Marrow Diseases
Hematologic Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on May 16, 2013