NCT00438178

Brief Summary

Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogneic 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

85
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
2 countries

3 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

October 1, 2005

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 22, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Last Updated

May 12, 2014

Status Verified

May 1, 2014

Enrollment Period

2 years

First QC Date

February 21, 2007

Last Update Submit

May 9, 2014

Conditions

Hematological Malignancies

Outcome Measures

Primary Outcomes (1)

  • Determine the recommended Phase II dose of GX15-070MS; Characterize the DLTs of GX15-070MS; Determine the PK/PD response to GX15-070MS

Secondary Outcomes (1)

  • Describe any clinical responses of patient with hematological malignancies.

Interventions

Obatoclax mesylate (GX15-070MS)DRUG

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically confirmation of AML, MDS, CML in blast phase, myelofibrosis, CLL, or aplastic anemia
  • There are no limitations on additional, allowable type and amount of prior therapy as long as acute toxicities have resolved to the allowable grade.
  • Must have normal organ functions
  • Must be willing to submit to blood sampling for the planned PK and PD analyses.
  • Must have the ability to understand and willingness to sign a written informed consent form

You may not qualify if:

  • No other agents or therapies administered for the intent to treat
  • Uncontrolled, intercurrent illness
  • Pregnant women and women who are breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, 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)

  • Schimmer AD, O'Brien S, Kantarjian H, Brandwein J, Cheson BD, Minden MD, Yee K, Ravandi F, Giles F, Schuh A, Gupta V, Andreeff M, Koller C, Chang H, Kamel-Reid S, Berger M, Viallet J, Borthakur G. A phase I study of the pan bcl-2 family inhibitor obatoclax mesylate in patients with advanced hematologic malignancies. Clin Cancer Res. 2008 Dec 15;14(24):8295-301. doi: 10.1158/1078-0432.CCR-08-0999.

    PMID: 19088047RESULT

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

obatoclax

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Jean Viallet, MD

    Gemin X, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 21, 2007

First Posted

February 22, 2007

Study Start

October 1, 2005

Primary Completion

October 1, 2007

Last Updated

May 12, 2014

Record last verified: 2014-05

Locations

US(2)CA(1)