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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Primary Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Using the International Working Group criteria, determine the number of patients that respond to AB0024 ater 2 cycles of treatment.

Outcome Description:

If no patients respond after 2 cycles, the study will be stopped.

Outcome Time Frame:

After 2 Cycle = 190 days

Safety Issue:

No

Principal Investigator

Dung Thai, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Arresto Biosciences, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

AB0024-102

NCT ID:

NCT01242709

Start Date:

February 2011

Completion Date:

December 2013

Related Keywords:

  • Primary Myelofibrosis
  • Post-Essential Thrombocythemia Myelofibrosis
  • Oncology
  • Hematology
  • Myelofibrosis
  • Thrombocythemia Myelofibrosis
  • Primary Myelofibrosis
  • Polycythemia
  • Polycythemia Vera
  • Thrombocythemia, Essential
  • Thrombocytosis

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
Stanford Cancer CenterStanford, California  94305-5824