Mantle-Cell LymphomaPhase 1/2NCT00407303
Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) in Combination With Bortezomib for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (MCL)
A Phase 1/2 study testing Obatoclax mesylate and Bortezomib in people with Mantle-Cell Lymphoma, run by Gemin X at 5 sites in United States.
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
- Mantle-Cell Lymphoma
- What is being tested?
- Obatoclax mesylate and Bortezomib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2006to Nov 2009
- Phase
- Phase 1/2
- 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 Mantle Cell Lymphoma (ML)
- Must have documented relapse or progression following 1 or 2 prior lines of antineoplastic therapy
- Must have normal organ function
- Must have the 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
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Roswell Park Medical Center
Buffalo, New York, 14263
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Hackensack University Medical Center
Hackensack, New Jersey, 07601
University of Wisconsin
Madison, Wisconsin, 53792
NW Georgia Oncology Centers
Marietta, Georgia, 30060
About this study
Official title: A Phase I/II Study of Obatoclax Mesylate (GX15-070MS) Administered in Combination With Bortezomib to Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL)
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 I study of Obatoclax administered in combination with bortezomib in 3-week cycles to patients with relapsed or refractory Mantle Cell Lymphoma. 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 patients's malignancy. Supportive care measures including those directed at controlling symptoms resulting from Mantle Cell Lymphoma are allowed.
- Conditions
- Mantle-Cell Lymphoma
- Being tested
- Obatoclax mesylate, Bortezomib
- Medical subject headings
- Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obatoclax mesylateDrug
Also called (GX15-070MS)
30 mg, 45 mg
BortezomibDrug
1.0mg/m2, 1.3 mg/m2
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 30mg obatoclax, 1.0mg/m2 bortezomib Receives: Drug: Obatoclax mesylate; Drug: Bortezomib |
| 2 | Experimental | obatoclax 30 mg, bortezomib 1.3 mg/m2 Receives: Drug: Obatoclax mesylate; Drug: Bortezomib |
| 3 | Experimental | Obatoclax 45 mg, Bortezomib 1.3 mg/m2 Receives: Drug: Obatoclax mesylate; Drug: Bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the response rate to obatoclax in combination with Bortezomib and characterize the safety profile
Measured: 4 weeks to 2 years
Secondary outcomes (1)
Peripheral blood counts; Bone marrow aspirates and biopsies; Transfusion and growth factor requirements
Measured: 4 weeks to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2006 (estimated)
- Study startOct 2006
- Primary completionMar 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mantle-Cell LymphomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
- Jean Viallet, MD, Study director, Gemin X, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00407303
- Sponsor's protocol ID
- GEM012
- Status last verified
- Jul 2016
- First submitted
- 1 Dec 2006
- Last updated
- 21 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Obatoclax Mesylate (GX15-070MS) Administered in Combination With Bortezomib to Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL)
- ClinicalTrials.gov ID
- NCT00407303
- Acronym / sponsor ID
- GEM012
- Conditions
- Mantle-Cell Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Gemin XIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 5 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 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 I study of Obatoclax administered in combination with bortezomib in 3-week cycles to patients with relapsed or refractory Mantle Cell Lymphoma. 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 patients's malignancy. Supportive care measures including those directed at controlling symptoms resulting from Mantle Cell Lymphoma are allowed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Obatoclax mesylate, Drug: Bortezomib30mg obatoclax, 1.0mg/m2 bortezomib |
| 2 | Experimental | Drug: Obatoclax mesylate, Drug: Bortezomibobatoclax 30 mg, bortezomib 1.3 mg/m2 |
| 3 | Experimental | Drug: Obatoclax mesylate, Drug: BortezomibObatoclax 45 mg, Bortezomib 1.3 mg/m2 |
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 Mantle Cell Lymphoma (ML)
- Must have documented relapse or progression following 1 or 2 prior lines of antineoplastic therapy
- Must have normal organ function
- Must have the 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 mesylateAlso: (GX15-070MS)30 mg, 45 mg | Drug | 1, 2, 3 |
| Bortezomib1.0mg/m2, 1.3 mg/m2 | Drug | 1, 2, 3 |
Primary outcome
Determine the response rate to obatoclax in combination with Bortezomib and characterize the safety profile
Time frame: 4 weeks to 2 years
1 secondary outcome
Peripheral blood counts; Bone marrow aspirates and biopsies; Transfusion and growth factor requirements
Time frame: 4 weeks to 2 years
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 21 Jul 2016.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Obatoclax mesylate and Bortezomib in people with Mantle-Cell Lymphoma, run by Gemin X at 5 sites in United States.
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 21 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 response rate to obatoclax in combination with Bortezomib and characterize the safety profile (time frame: 4 weeks to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2016.