Safety and Efficacy of Obatoclax Mesylate (GX15-070MS)for the Treatment of Myelodysplastic Syndromes (MDS)
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Myelodysplastic Syndromes |
Drug: Obatoclax mesylate (GX15-070MS) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Obatoclax Mesylate (GX15-070MS) in Patients With Previously-Untreated Myelodysplastic Syndromes (MDS) With Anemia and/or Thrombocytopenia |
- International Working Group (IWG) Response Criteria for MDS [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]Determine the response rate according to bone marrow blast count less than or equal to 10%
- Peripheral blood counts; Bone marrow aspirates and biopsies; Transfusions and growth factor requirements [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]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
| Enrollment: | 24 |
| Study Start Date: | December 2006 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Obatoclax Mesylate
Obatoclax Mesylate 30mg
|
Drug: Obatoclax mesylate (GX15-070MS) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 22 Study Locations| Study Director: | Mark Berger, MD | Gemin X, Inc. |
More Information
No publications provided
| Responsible Party: | Teva Pharmaceutical Industries ( Gemin X ) |
| ClinicalTrials.gov Identifier: | NCT00413114 History of Changes |
| Other Study ID Numbers: | GEM013 |
| Study First Received: | December 18, 2006 |
| Last Updated: | August 3, 2012 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Additional relevant MeSH terms:
|
Myelodysplastic Syndromes Preleukemia Bone Marrow Diseases |
Hematologic Diseases Precancerous Conditions Neoplasms |
ClinicalTrials.gov processed this record on May 16, 2013