NCT00360035

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2006

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

August 26, 2013

Status Verified

August 1, 2013

Enrollment Period

1.7 years

First QC Date

August 1, 2006

Last Update Submit

August 16, 2013

Conditions

Myelofibrosis

Outcome Measures

Primary Outcomes (1)

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

    1 Year

Secondary Outcomes (3)

  • Peripheral blood counts

    4 Weeks to 1 Year

  • Bone marrow aspirates and biopsies

    8 weeks to 1 year

  • Transfusion and growth factor requirements

    8 weeks to 1 year

Study Arms (1)

GX15-070MS

EXPERIMENTAL

Obatoclax mesylate 60mg

Drug: Obatoclax mesylate (GX15-070MS)

Interventions

Obatoclax mesylate (GX15-070MS)DRUG

60 mg q2wks

GX15-070MS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

James A. Haley Veterans Hospital

Tampa, Florida, 33612, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

The University of Chicago

Chicago, Illinois, 60637, United States

Location

University of Massachusetts Medical Center

Worcester, Massachusetts, 01655, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

  • Parikh SA, Kantarjian H, Schimmer A, Walsh W, Asatiani E, El-Shami K, Winton E, Verstovsek S. Phase II study of obatoclax mesylate (GX15-070), a small-molecule BCL-2 family antagonist, for patients with myelofibrosis. Clin Lymphoma Myeloma Leuk. 2010 Aug;10(4):285-9. doi: 10.3816/CLML.2010.n.059.

    PMID: 20709666RESULT

MeSH Terms

Conditions

Primary Myelofibrosis

Interventions

obatoclax

Condition Hierarchy (Ancestors)

Myeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Jean Viallet, MD

    Gemin X, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2006

First Posted

August 3, 2006

Study Start

July 1, 2006

Primary Completion

March 1, 2008

Study Completion

February 1, 2009

Last Updated

August 26, 2013

Record last verified: 2013-08

Locations

US(6)CA(1)