Skip to main content
OpenTrials
Completed

NCT Number: NCT00413114

Safety and Efficacy of Obatoclax Mesylate (GX15-070MS)for the Treatment of Myelodysplastic Syndromes (MDS)

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

This is a multi-center, open-label, Phase II study of obatoclax administered in 2-week cycles to patients with previously-untreated Myelodysplastic Syndromes with anemia and/or thrombocytopenia. Treatment may be administered on an outpatient basis. No investigational or commercial agents or therapies other than those described herein may be administered with the intent to treat the patient's malignancy. Supportive care measures including those directed at controlling symptoms resulting from Myelodysplastic Syndromes are allowed

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Myelodysplastic Syndromes Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tom Baker Cancer Centre, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pathological confirmation of Myelodysplastic Syndromes (MDS)
  • Patients must have had no prior systemic therapy
  • Must have normal organ functions
  • Must have the ability to understand and willingness to sign a written informed consent form

Exclusion criteria

  • Must not be a result of prior chemotherapy and/or radiotherapy for another malignancy
  • No other agents or therapies administered in the intent to treat
  • Uncontrolled, intercurrent illness
  • Pregnant women and women who are breast feeding

Treatment and study plan

Obatoclax mesylate (GX15-070MS)

Drug

Primary outcomes

  1. International Working Group (IWG) Response Criteria for MDS

    Time frame: 52 weeks

    Determine the response rate according to bone marrow blast count less than or equal to 10%

Secondary outcomes

  1. Peripheral blood counts; Bone marrow aspirates and biopsies; Transfusions and growth factor requirements

    Time frame: 52 weeks

    hemoglobin level less than 10 g/dL and or platelets less than 50 x 10 9/L. Eastern Cooperative Onocology Group (ECOG) performance status: 0 fully active-2 ambulatory 50% of the time; and total bilirubin less than or equal to 2 mg/dL; normal limits of SGOT/SGPT and creatinine according to laboratory standards

Sponsors and collaborators

Lead sponsor

Gemin X

Industry

Registry information

Official study title

A Phase II Study of Obatoclax Mesylate (GX15-070MS) in Patients With Previously-Untreated Myelodysplastic Syndromes (MDS) With Anemia and/or Thrombocytopenia

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Dec 19, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.