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OpenTrials
Completed

NCT Number: NCT00360035

Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) in the Treatment of Myelofibrosis With Myeloid Metaplasia

Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogenic signal is present. Obatoclax is designed to restore apoptosis through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process of cell death that is often inhibited in cancer cells.

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Key information

Conditions

Myelofibrosis Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myeloproliferative Disorders Primary Myelofibrosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Princess Margaret Hospital, Toronto, Ontario, Canada

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About this study

This is a multi-center, open-label, Phase II study of single-agent obatoclax administered in 2-week cycles as a 24-hour infusion every 2 weeks at a fixed dose of 60 mg to patients with myelofibrosis. Infusions may be administered on an outpatient basis. No investigational or commercial agents or therapies other than those described in the protocol may be administered with the intent to treat the patient's malignancy. Supportive care measures including those directed at controlling symptoms resulting from myelofibrosis (blood products, growth factor, hydroxyurea, etc.) are allowed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed myelofibrosis with myeloid metaplasia.
  • No limitations on allowable type and amount of prior therapy.
  • Patients must have normal organ function.
  • Must be willing to submit to blood sampling for planned PK and PD analyzes.
  • Must have ability to understand and willingness to sign a written informed consent form.

Exclusion criteria

  • No other agents or therapies administered with the intent to treat malignancy.
  • Patients with prior exposure to obatoclax.
  • Uncontrolled, intercurrent illness.
  • Pregnant women and women who are breast feeding.

Treatment and study plan

Obatoclax mesylate (GX15-070MS)

Drug

60 mg q2wks

Primary outcomes

  1. Determine the steady-state pharmacokinetic parameters and pharmacodynamic response.

    Time frame: 1 Year

Secondary outcomes

  1. Peripheral blood counts

    Time frame: 4 Weeks to 1 Year

  2. Bone marrow aspirates and biopsies

    Time frame: 8 weeks to 1 year

  3. Transfusion and growth factor requirements

    Time frame: 8 weeks to 1 year

Sponsors and collaborators

Lead sponsor

Gemin X

Industry

Registry information

Official study title

A Multi-Center, Open-Label, Phase II Study of Single-Agent GX15-070MS Administered as a 24-Hour Infusion Every 2 Weeks to Patients With Myelofibrosis With Myeloid Metaplasia (MF)

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Aug 3, 2006
Registry last updated
Aug 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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