AMLPhase 2NCT00684918
Study of Obatoclax in Previously Untreated Acute Myeloid Leukemia (AML)
A Phase 2 study testing Obatoclax in people with AML, run by Gemin X at 13 sites in 2 countries.
Trial summary
This protocol will evaluate the efficacy of obatoclax in older patients with previously untreated AML. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- AML
- What is being tested?
- Obatoclax
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Apr 2008to Dec 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Histologically or cytologically confirmed AML
- No prior chemotherapy for AML (with the exception that the patients enrolled in the Pilot Safety evaluation may have had 1 prior therapy)
- Age ≥70 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2
- Patients must have normal organ function as defined below:
- Total bilirubin < or = 2 mg/dL unless resulting from hemolysis,
- Aspartate transaminase (AST [SGOT])/alanine transaminase (ALT [SGPT]) < or = 2.5 x institutional ULN
- Creatinine within normal institutional limits, OR creatinine clearance > or = 50 mL/min/1.73 meters squared for patients with creatinine levels above institutional ULN
Who cannot join
- Patients who have received or are receiving any other investigational or commercial agents or therapies administered with the intent to treat their malignancy (with the exception that the patients enrolled in the pilot safety evaluation may have had 1 prior therapy)
- patients with history of allergic reactions attributed to components of the formulated product (PEG300 and polysorbate 20)
- patients with history of seizure disorders or central nervous system leukemia
- patients with uncontrolled, intercurrent illness including, but not limited to, symptomatic neurological illness; active, uncontrolled, systemic infection considered opportunistic, life-threatening, or clinically significant at the time of treatment; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; significant pulmonary disease or hypoxia; or psychiatric illness/social situations that would limit compliance with study requirements
- Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States12 sites
St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48106
University of Michigan Health System
Ann Arbor, Michigan, 48109
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Northwestern University
Chicago, Illinois, 60611
Penn State Hershey Cancer Institute-Clinical Trials Office
Hershey, Pennsylvania, 17033
MD Anderson Cancer Center
Houston, Texas, 77030
The University of Iowa
Iowa City, Iowa, 52242
Michigan State University - Breslin Cancer Center
Lansing, Michigan, 48910
St. Vincent's Comprehensive Cancer Center
New York, New York, 10011
Legacy Emanuel Hospital & Health Center
Portland, Oregon, 97210
Benaroya Research Institute at Virginia Mason
Seattle, Washington, 98101
University of Kansas Medical Center Research Institute
Westwood, Kansas, 66205
About this study
Official title: A Multicenter, Open-Label, 2-Stage, Phase II Study of Single-Agent Obatoclax Mesylate Administered For Three Consecutive Days Every 2 Weeks to Older Patients With Previously Untreated Acute Myeloid Leukemia (AML)
This protocol will evaluate the efficacy of obatoclax in older patients with previously untreated AML.
Read the detailed description
The Pilot Safety portion of the study will evaluate the safety of obatoclax administered by a 3 hour infusion for 3 days in a row. The Pilot Schedule portion of the study will randomize 16 patients in to one of two cohorts: 1) patients receiving obatoclax administered by a 3 hour infusion for 3 days in a row or 2) patients receiving obatoclax administered by a 24 hour infusion for 3 days in a row. The schedule with the best overall efficacy and safety in the Pilot Schedule portion of the study will then be utilized in the Phase II portion of the study.
- Conditions
- AML
- Being tested
- Obatoclax
- Keywords
- AML, obatoclax
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObatoclaxDrug
Also called GX15-070MS
A 3-hour IV infusion for 3 consecutive days or a 24-hour infusion for 3 consecutive days every 2 weeks for up to 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | In the Pilot Schedule portion of the study 3 hour vs 24 hour infusion schedules of obatoclax. Receives: Drug: Obatoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the rate of morphologic CR after treatment in the obatoclax single-agent therapy in older patients with previously untreated AML.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2008 (estimated)
- Study startApr 2008
- Primary completionAug 2009
- Study completionDec 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 AMLStudies 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
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 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 Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00684918
- Sponsor's protocol ID
- GEM016
- Status last verified
- Aug 2013
- First submitted
- 23 May 2008
- Last updated
- 26 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Schimmer AD, Raza A, Carter TH, Claxton D, Erba H, DeAngelo DJ, Tallman MS, Goard C, Borthakur G. A multicenter phase I/II study of obatoclax mesylate administered as a 3- or 24-hour infusion in older patients with previously untreated acute myeloid leukemia. PLoS One. 2014 Oct 6;9(10):e108694. doi: 10.1371/journal.pone.0108694. eCollection 2014.
PubMed 25285531
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 Multicenter, Open-Label, 2-Stage, Phase II Study of Single-Agent Obatoclax Mesylate Administered For Three Consecutive Days Every 2 Weeks to Older Patients With Previously Untreated Acute Myeloid Leukemia (AML)
- ClinicalTrials.gov ID
- NCT00684918
- Acronym / sponsor ID
- GEM016
- Conditions
- AML
- Keywords
- AML, obatoclax
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Gemin XIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 28 May 2008 (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.
This protocol will evaluate the efficacy of obatoclax in older patients with previously untreated AML.
Detailed description
The Pilot Safety portion of the study will evaluate the safety of obatoclax administered by a 3 hour infusion for 3 days in a row. The Pilot Schedule portion of the study will randomize 16 patients in to one of two cohorts: 1) patients receiving obatoclax administered by a 3 hour infusion for 3 days in a row or 2) patients receiving obatoclax administered by a 24 hour infusion for 3 days in a row. The schedule with the best overall efficacy and safety in the Pilot Schedule portion of the study will then be utilized in the Phase II portion of the study.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: ObatoclaxIn the Pilot Schedule portion of the study 3 hour vs 24 hour infusion schedules of obatoclax. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Histologically or cytologically confirmed AML
- No prior chemotherapy for AML (with the exception that the patients enrolled in the Pilot Safety evaluation may have had 1 prior therapy)
- Age ≥70 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2
- Patients must have normal organ function as defined below:
Key exclusion criteria (5 listed)
- Patients who have received or are receiving any other investigational or commercial agents or therapies administered with the intent to treat their malignancy (with the exception that the patients enrolled in the pilot safety evaluation may have had 1 prior therapy)
- patients with history of allergic reactions attributed to components of the formulated product (PEG300 and polysorbate 20)
- patients with history of seizure disorders or central nervous system leukemia
- patients with uncontrolled, intercurrent illness including, but not limited to, symptomatic neurological illness; active, uncontrolled, systemic infection considered opportunistic, life-threatening, or clinically significant at the time of treatment; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; significant pulmonary disease or hypoxia; or psychiatric illness/social situations that would limit compliance with study requirements
- Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy
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 |
|---|---|---|
| ObatoclaxAlso: GX15-070MSA 3-hour IV infusion for 3 consecutive days or a 24-hour infusion for 3 consecutive days every 2 weeks for up to 6 cycles. | Drug | Experimental |
Primary outcome
Determine the rate of morphologic CR after treatment in the obatoclax single-agent therapy in older patients with previously untreated AML.
Time frame: 4 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 25285531Schimmer AD, Raza A, Carter TH, Claxton D, Erba H, DeAngelo DJ, Tallman MS, Goard C, Borthakur G. A multicenter phase I/II study of obatoclax mesylate administered as a 3- or 24-hour infusion in older patients with previously untreated acute myeloid leukemia. PLoS One. 2014 Oct 6;9(10):e108694. doi: 10.1371/journal.pone.0108694. eCollection 2014.
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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 Pharmaceuticals
13 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 in people with AML, run by Gemin X at 13 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 8 inclusion and 5 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 13 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 rate of morphologic CR after treatment in the obatoclax single-agent therapy in older patients with previously untreated AML. (time frame: 4 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 NCT00684918, 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.