LymphomaPhase 2NCT00359086
Study of MGCD0103 Given Three Times Weekly in Patients With Relapsed and Refractory Lymphoma
A Phase 2 study testing MGCD0103 in people with Lymphoma, run by Mirati Therapeutics Inc. at 5 sites in 2 countries.
Trial summary
In this study, MGCD0103, a new anticancer drug under investigation, is given three times weekly to patients with relapsed and refractory lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- MGCD0103
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Aug 2006to Jan 2012
- 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
- Pathologic confirmation of relapsed or refractory lymphoma.
- DLBCL stage II-IV
- Follicular lymphoma
- At least one site of measurable disease (≥ 2.0 cm with conventional techniques; physical exam [PE], CT, X-ray, MRI).
- Prior treatment:
- DLBCL cohort: Disease progression following initial therapy and transplant (unless the patient is ineligible or refused transplant). There is no limit to number of prior therapies.
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- Follicular lymphoma cohort: Follicular lymphoma that is relapsed following or refractory to standard therapy and/or existing therapies or are not eligible for or are unlikely to achieve clinical benefit from those therapies. Patients must have failed 3 or more prior therapies.
- Must have at least one of the following considered related to disease:
- Local symptoms due to progressive or bulky nodal disease.
- Compromise of normal organ function due to progressive or bulky disease.
- Presence of systemic B symptoms.
- Presence of symptomatic extranodal disease.
- Cytopenias due to extensive bone marrow infiltration, autoimmune hemolytic anemia or thrombocytopenia, or hypersplenism.
- ECOG performance status of 0 or 1.
- Aged 18 years or older.
- Laboratory requirements.
Who cannot join
- Patients with another active cancer (excluding basal cell carcinoma or cervical intraepithelial neoplasia [CIN/cervical in situ] or melanoma in situ). Prior history of cancer is allowed, as long as there is no active disease.
- Pregnant or lactating women.
- Patients with uncontrolled intercurrent illness, active or uncontrolled infections, or a fever >38.5 Celsius (not due to tumor fever) on the day of scheduled dosing.
- Patients with a history of pericardial disease.
- Patients with small, moderate or large pericardial effusions or patients with a diagnosis of pericarditis.
- Patients with significant cardiac abnormalities.
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- Patients with serious illnesses, medical conditions, or other medical history which would be likely to interfere with patient's participation in the study or with the interpretation of the results.
- Patients who have been treated with any investigational drug within 28 days prior to study initiation.
- Known hypersensitivity to HDAC inhibitors and to any components of MGCD0103.
- Known human immunodeficiency virus (HIV) or active Hepatitis B or C.
- Central nervous system lymphoma and lymphoma involving leptomeningeal area.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Canada3 sites
Charles LeMoyne Hospital
Greenfield Park, Quebec, J4V 2H1
Sir Mortimer Davis-Jewish General Hospital
Montreal, Quebec, H3T 1E2
Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6
United States2 sites
Duke University Adult Bone Marrow Transplant Clinic
Durham, North Carolina, 27710
MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase II Study of MGCD0103 (MG-0103) Given Three Times Weekly in Patients With Relapsed and Refractory Lymphoma
In this study, MGCD0103, a new anticancer drug under investigation, is given three times weekly to patients with relapsed and refractory lymphoma.
- Conditions
- Lymphoma
- Being tested
- MGCD0103
- Keywords
- Relapsed and Refractory Lymphoma, Phase II
- Medical subject headings
- Lymphoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGCD0103Drug
MGCD0103 given orally three times per week
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: MGCD0103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Measured: 1 year (anticipated)
Secondary outcomes (5)
Progression-free survival
Measured: 1 year (anticipated)
Duration of objective response
Measured: 1 year (anticipated)
Safety profile
Measured: 1 year (anticipated)
Pharmacokinetics
Measured: 1 year (anticipated)
Pharmacodynamics
Measured: 1 year (anticipated)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mirati Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregory Reid, MSc, MBA, Study director, MethylGene Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00359086
- Sponsor's protocol ID
- 0103-008
- Status last verified
- Jun 2015
- First submitted
- 31 Jul 2006
- Last updated
- 1 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of MGCD0103 (MG-0103) Given Three Times Weekly in Patients With Relapsed and Refractory Lymphoma
- ClinicalTrials.gov ID
- NCT00359086
- Acronym / sponsor ID
- 0103-008
- Conditions
- Lymphoma
- Keywords
- Relapsed and Refractory Lymphoma, Phase II
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Mirati Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 1 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.
In this study, MGCD0103, a new anticancer drug under investigation, is given three times weekly to patients with relapsed and refractory lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MGCD0103 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Pathologic confirmation of relapsed or refractory lymphoma.
- At least one site of measurable disease (≥ 2.0 cm with conventional techniques; physical exam [PE], CT, X-ray, MRI).
- Prior treatment:
- Must have at least one of the following considered related to disease:
- ECOG performance status of 0 or 1.
Key exclusion criteria (11 listed)
- Patients with another active cancer (excluding basal cell carcinoma or cervical intraepithelial neoplasia [CIN/cervical in situ] or melanoma in situ). Prior history of cancer is allowed, as long as there is no active disease.
- Pregnant or lactating women.
- Patients with uncontrolled intercurrent illness, active or uncontrolled infections, or a fever >38.5 Celsius (not due to tumor fever) on the day of scheduled dosing.
- Patients with a history of pericardial disease.
- Patients with small, moderate or large pericardial effusions or patients with a diagnosis of pericarditis.
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 |
|---|---|---|
| MGCD0103MGCD0103 given orally three times per week | Drug | 1 |
Primary outcome
Response rate
Time frame: 1 year (anticipated)
5 secondary outcomes
Progression-free survival
Time frame: 1 year (anticipated)
Duration of objective response
Time frame: 1 year (anticipated)
Safety profile
Time frame: 1 year (anticipated)
Pharmacokinetics
Time frame: 1 year (anticipated)
Pharmacodynamics
Time frame: 1 year (anticipated)
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 1 Jul 2015.
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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.
Gregory Reid, MSc, MBA study director
MethylGene Inc.
5 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 MGCD0103 in people with Lymphoma, run by Mirati Therapeutics Inc. at 5 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 16 inclusion and 11 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 1 Jul 2015. 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 Canada, 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 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?
Response rate (time frame: 1 year (anticipated)). 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 1 Jul 2015; AzTrials last refreshed its copy on 7 Nov 2026.