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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)


Phase 2
18 Years
N/A
Not Enrolling
Both
Myelofibrosis

Thank you

Trial Information

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)


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the steady-state pharmacokinetic parameters and pharmacodynamic response.

Outcome Time Frame:

1 Year

Safety Issue:

No

Principal Investigator

Jean Viallet, MD

Investigator Role:

Study Director

Investigator Affiliation:

Gemin X, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

GEM007

NCT ID:

NCT00360035

Start Date:

July 2006

Completion Date:

February 2009

Related Keywords:

  • Myelofibrosis
  • Primary Myelofibrosis
  • Metaplasia

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
Emory UniversityAtlanta, Georgia  30322
Georgetown University Medical CenterWashington, District of Columbia  20007
The University of ChicagoChicago, Illinois  60637
James A. Haley Veterans HospitalTampa, Florida  33612
University of Massachusetts Medical CenterWorcester, Massachusetts  01605