Myelodysplastic SyndromesPhase 2NCT00413114
Safety and Efficacy of Obatoclax Mesylate (GX15-070MS)for the Treatment of Myelodysplastic Syndromes (MDS)
A Phase 2 study testing Obatoclax mesylate (GX15-070MS) in people with Myelodysplastic Syndromes, run by Gemin X at 22 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes
- What is being tested?
- Obatoclax mesylate (GX15-070MS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 22 sitesin 2 countries
- Study dates
- Dec 2006to Nov 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
United States17 sites
Arlington Cancer Center
Arlington, Texas, 76012
Emory University School of Medicine/ Winship Cancer Center
Atlanta, Georgia, 30322
Hematology-Oncology Centers of the Northern Rockies
Billings, Montana, 59101
University of Chicago
Chicago, Illinois, 60637
Texax Oncology, P.A., Presbyterian/ Mary Crowley Clinical Research Centers
Dallas, Texas, 75231
Mary Crowley Medical Research Center
Dallas, Texas, 75246
MD Anderson Cancer Center (Protocol 2006-0688)
Houston, Texas, 77030
Michigan State University, Breslin Cancer Center CTO
Lansing, Michigan, 48910
Northwest Georgia Oncology Centers
Marietta, Georgia, 30060
The West Clinic
Memphis, Tennessee, 38120
Sarah Cannon Cancer Research Institute
Nashville, Tennessee, 37203
St. Vincent's Comprehensive Cancer Center
New York, New York, 01605
Pacific Oncology
Portland, Oregon, 97210
Stanford University
Stanford, California, 00000
James A. Haley Veterans Hospital
Tampa, Florida, 33612
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
University of Massachusetts Medical Center
Worcester, Massachusetts, 01605
Canada5 sites
Tom Baker Cancer Centre
Calgary, Alberta
QEII HSC
Halifax, Nova Scotia, B3H 2Y9
Hospital Notre-Dame du Chum
Montreal, Quebec, H2L4M1
Maisonneuve-Rosemont Hospital
Montreal, Quebec
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
Official title: A Phase II Study of Obatoclax Mesylate (GX15-070MS) in Patients With Previously-Untreated Myelodysplastic Syndromes (MDS) With Anemia and/or Thrombocytopenia
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
- Conditions
- Myelodysplastic Syndromes
- Being tested
- Obatoclax mesylate (GX15-070MS)
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obatoclax mesylate (GX15-070MS)Drug
| Study group | Role | What they receive |
|---|---|---|
| Obatoclax Mesylate | Experimental | Obatoclax Mesylate 30mg Receives: Drug: Obatoclax mesylate (GX15-070MS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Working Group (IWG) Response Criteria for MDS
Determine the response rate according to bone marrow blast count less than or equal to 10%
Measured: 52 weeks
Secondary outcomes (1)
Peripheral blood counts; Bone marrow aspirates and biopsies; Transfusions and growth factor requirements
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
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionFeb 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gemin X
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Berger, MD, Study director, Gemin X, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00413114
- Sponsor's protocol ID
- GEM013
- Status last verified
- Aug 2013
- First submitted
- 18 Dec 2006
- Last updated
- 26 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Arellano ML, Borthakur G, Berger M, Luer J, Raza A. A phase II, multicenter, open-label study of obatoclax mesylate in patients with previously untreated myelodysplastic syndromes with anemia or thrombocytopenia. Clin Lymphoma Myeloma Leuk. 2014 Dec;14(6):534-9. doi: 10.1016/j.clml.2014.04.007. Epub 2014 Jun 12.
PubMed 25052051
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Obatoclax Mesylate (GX15-070MS) in Patients With Previously-Untreated Myelodysplastic Syndromes (MDS) With Anemia and/or Thrombocytopenia
- ClinicalTrials.gov ID
- NCT00413114
- Acronym / sponsor ID
- GEM013
- Conditions
- Myelodysplastic Syndromes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Gemin XIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 19 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obatoclax Mesylate | Experimental | Drug: Obatoclax mesylate (GX15-070MS)Obatoclax Mesylate 30mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obatoclax mesylate (GX15-070MS) | Drug | Obatoclax Mesylate |
Primary outcome
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%
1 secondary outcome
Peripheral blood counts; Bone marrow aspirates and biopsies; Transfusions and growth factor requirements
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
- Derived from this study: PubMed 25052051Arellano ML, Borthakur G, Berger M, Luer J, Raza A. A phase II, multicenter, open-label study of obatoclax mesylate in patients with previously untreated myelodysplastic syndromes with anemia or thrombocytopenia. Clin Lymphoma Myeloma Leuk. 2014 Dec;14(6):534-9. doi: 10.1016/j.clml.2014.04.007. Epub 2014 Jun 12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Berger, MD study director
Gemin X, Inc.
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Obatoclax mesylate (GX15-070MS) in people with Myelodysplastic Syndromes, run by Gemin X at 22 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Working Group (IWG) Response Criteria for MDS (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00413114, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2013.