MyelofibrosisPhase 2NCT00360035
Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) in the Treatment of Myelofibrosis With Myeloid Metaplasia
A Phase 2 study testing Obatoclax mesylate (GX15-070MS) in people with Myelofibrosis, run by Gemin X at 7 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 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelofibrosis
- What is being tested?
- Obatoclax mesylate (GX15-070MS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Jul 2006to Feb 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Emory University
Atlanta, Georgia, 30322
The University of Chicago
Chicago, Illinois, 60637
MD Anderson Cancer Center
Houston, Texas, 77030
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, 01655
About this study
Official title: A Multi-Center, Open-Label, Phase II Study of Single-Agent GX15-070MS Administered as a 24-Hour Infusion Every 2 Weeks to Patients With Myelofibrosis With Myeloid Metaplasia (MF)
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.
Read the detailed description
This is a multi-center, open-label, Phase II study of single-agent obatoclax administered in 2-week cycles as a 24-hour infusion every 2 weeks at a fixed dose of 60 mg to patients with myelofibrosis. Infusions may be administered on an outpatient basis. No investigational or commercial agents or therapies other than those described in the protocol may be administered with the intent to treat the patient's malignancy. Supportive care measures including those directed at controlling symptoms resulting from myelofibrosis (blood products, growth factor, hydroxyurea, etc.) are allowed.
- Conditions
- Myelofibrosis
- Being tested
- Obatoclax mesylate (GX15-070MS)
- Medical subject headings
- Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obatoclax mesylate (GX15-070MS)Drug
60 mg q2wks
| Study group | Role | What they receive |
|---|---|---|
| GX15-070MS | Experimental | Obatoclax mesylate 60mg Receives: Drug: Obatoclax mesylate (GX15-070MS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the steady-state pharmacokinetic parameters and pharmacodynamic response.
Measured: 1 Year
Secondary outcomes (3)
Peripheral blood counts
Measured: 4 Weeks to 1 Year
Bone marrow aspirates and biopsies
Measured: 8 weeks to 1 year
Transfusion and growth factor requirements
Measured: 8 weeks to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2006 (estimated)
- Study startJul 2006
- Primary completionMar 2008
- Study completionFeb 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 MyelofibrosisStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gemin X
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean Viallet, MD, Study director, Gemin X, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00360035
- Sponsor's protocol ID
- GEM007
- Status last verified
- Aug 2013
- First submitted
- 1 Aug 2006
- Last updated
- 26 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20709666
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 Multi-Center, Open-Label, Phase II Study of Single-Agent GX15-070MS Administered as a 24-Hour Infusion Every 2 Weeks to Patients With Myelofibrosis With Myeloid Metaplasia (MF)
- ClinicalTrials.gov ID
- NCT00360035
- Acronym / sponsor ID
- GEM007
- Conditions
- Myelofibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Gemin XIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 3 Aug 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 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.
Detailed description
This is a multi-center, open-label, Phase II study of single-agent obatoclax administered in 2-week cycles as a 24-hour infusion every 2 weeks at a fixed dose of 60 mg to patients with myelofibrosis. Infusions may be administered on an outpatient basis. No investigational or commercial agents or therapies other than those described in the protocol may be administered with the intent to treat the patient's malignancy. Supportive care measures including those directed at controlling symptoms resulting from myelofibrosis (blood products, growth factor, hydroxyurea, etc.) are allowed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GX15-070MS | Experimental | Drug: Obatoclax mesylate (GX15-070MS)Obatoclax mesylate 60mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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)60 mg q2wks | Drug | GX15-070MS |
Primary outcome
Determine the steady-state pharmacokinetic parameters and pharmacodynamic response.
Time frame: 1 Year
3 secondary outcomes
Peripheral blood counts
Time frame: 4 Weeks to 1 Year
Bone marrow aspirates and biopsies
Time frame: 8 weeks to 1 year
Transfusion and growth factor requirements
Time frame: 8 weeks to 1 year
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.
- Results publication: PubMed 20709666Parikh 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.
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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.
Jean Viallet, MD study director
Gemin X, Inc.
7 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 Myelofibrosis, run by Gemin X at 7 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 5 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 7 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?
Determine the steady-state pharmacokinetic parameters and pharmacodynamic response. (time frame: 1 Year). 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 NCT00360035, 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.