Myelogenous Leukemia, AcutePhase 2NCT00374296
MGCD0103 in Elderly Patients With Previously Untreated AML/High Risk MDS or Adults With Relapsed/Refractory Disease
A Phase 2 study testing MGCD0103 in people with Myelogenous Leukemia, Acute and Myelodysplastic Syndromes, run by Mirati Therapeutics Inc. at 13 sites in 2 countries.
Trial summary
In this study, MGCD0103, a new anticancer drug under investigation, is given three times per week to elderly patients with previously untreated acute myelogenous leukemia/high risk myelodysplastic syndrome or adults with relapsed/refractory disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelogenous Leukemia, Acute, Myelodysplastic Syndromes
- 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
- 35 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Sep 2006to Sep 2008
- 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 AML or high risk MDS.
- Elderly cohort (70 years of age or more): no prior chemotherapy treatment for AML/high risk MDS and not currently candidates for intensive chemotherapy.
- Relapsed/refractory cohort (18 years of age or more): relapsed or refractory to prior treatment.
- ECOG performance status of 0 or 1.
- Total bilirubin < 1.5 x upper limit of normal (ULN).
- AST/SGOT and ALT/SGPT < 2.5 x ULN.
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- Serum creatinine < 1.5 x ULN.
- Patients must read, understand, and sign a written informed consent form (ICF).
- Women of childbearing potential and male patients' female partners must use an acceptable method of contraception while on study, and for 3 months after study drug treatment.
Who cannot join
- Pregnant or lactating women.
- Patients with uncontrolled, intercurrent illness, active or uncontrolled infections, or a fever > 38.5C (not due to tumor fever) on the day of scheduled dosing.
- Patients with serious illnesses or medical conditions, including laboratory results, which, in the investigator's opinion, would interfere with a patient's participation, or with the interpretation of the results.
- Patients treated with an investigational drug within 30 days prior to study initiation.
- Known hypersensitivity to HDAC inhibitors or to any of the components of MG-0103.
- Known HIV or active hepatitis B or C.
- Any condition that may affect the patient's ability to sign the ICF and undergo study procedures.
- Any conditions that will put the patient at undue risk or discomfort as a result of adherence to study procedures.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
Canada7 sites
Hopital Charles Lemoyne
Greenfield Park, Quebec, J4V 2H1
Hamilton Health Sciences - McMaster Hospital
Hamilton, Ontario, L8N 3Z5
Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
Hopital Notre-Dame du CHUM
Montreal, Quebec, H2L 4M1
Sir Mortimer Davis-Jewish General Hospital
Montreal, Quebec, H3T 1E2
Universite de Sherbrooke, Service d'hematologie
Sherbrooke, Quebec, J1H 5N4
UHN - Princess Margaret Hospital
Toronto, Ontario, M5G 2M6
United States6 sites
Gabrail Cancer Center
Canton, Ohio, 44718
Cleveland Clinic
Cleveland, Ohio, 44195
Ohio State University Medical Center - James Cancer Hospital
Columbus, Ohio, 43210
MD Anderson Cancer Center
Houston, Texas, 77030
Veterans Affairs Medical Center
Kansas City, Missouri, 64128
University of Rochester Medical Center
Rochester, New York, 14642-0001
About this study
Official title: A Phase II Study of MGCD0103 (MG-0103) in Patients With Acute Myelogenous Leukemia/High Risk MDS Who Are Elderly and Have Previously Untreated Disease or Who Are Adult and Have Relapsed/Refractory Disease
In this study, MGCD0103, a new anticancer drug under investigation, is given three times per week to elderly patients with previously untreated acute myelogenous leukemia/high risk myelodysplastic syndrome or adults with relapsed/refractory disease.
- Being tested
- MGCD0103
- Keywords
- Leukemia, MDS, Phase II, Acute Myelogenous Leukemia (AML), High Risk Myelodysplastic Syndromes (MDS)
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGCD0103Drug
MGCD0103 administered orally three-times per week
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Elderly (≥65 years) untreated arm |
| 2 | Experimental | Relapsed/Refractory Arm Receives: Drug: MGCD0103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Measured: 1 year (anticipated
Response rate
Measured: 1 year (anticipated)
Secondary outcomes (4)
Progression-free survival
Measured: 1 year (anticipated)
Duration of objective response
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 posted11 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionSep 2008
- Study completionSep 2008
Why it stopped: The Clinical Development Program for MGCD0103 is being re-evaluated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelogenous Leukemia, AcuteStudies 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
- 35 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
- NCT00374296
- Sponsor's protocol ID
- 0103-007
- Status last verified
- Jun 2015
- First submitted
- 7 Sep 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) in Patients With Acute Myelogenous Leukemia/High Risk MDS Who Are Elderly and Have Previously Untreated Disease or Who Are Adult and Have Relapsed/Refractory Disease
- ClinicalTrials.gov ID
- NCT00374296
- Acronym / sponsor ID
- 0103-007
- Keywords
- Leukemia, MDS, Phase II, Acute Myelogenous Leukemia (AML), High Risk Myelodysplastic Syndromes (MDS)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Clinical Development Program for MGCD0103 is being re-evaluated
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Mirati Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 11 Sep 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 per week to elderly patients with previously untreated acute myelogenous leukemia/high risk myelodysplastic syndrome or adults with relapsed/refractory disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Elderly (≥65 years) untreated arm |
| 2 | Experimental | Drug: MGCD0103Relapsed/Refractory Arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Pathologic confirmation of AML or high risk MDS.
- Elderly cohort (70 years of age or more): no prior chemotherapy treatment for AML/high risk MDS and not currently candidates for intensive chemotherapy.
- Relapsed/refractory cohort (18 years of age or more): relapsed or refractory to prior treatment.
- ECOG performance status of 0 or 1.
- Total bilirubin < 1.5 x upper limit of normal (ULN).
Key exclusion criteria (8 listed)
- Pregnant or lactating women.
- Patients with uncontrolled, intercurrent illness, active or uncontrolled infections, or a fever > 38.5C (not due to tumor fever) on the day of scheduled dosing.
- Patients with serious illnesses or medical conditions, including laboratory results, which, in the investigator's opinion, would interfere with a patient's participation, or with the interpretation of the results.
- Patients treated with an investigational drug within 30 days prior to study initiation.
- Known hypersensitivity to HDAC inhibitors or to any of the components of MG-0103.
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 administered orally three-times per week | Drug | 2 |
Primary outcome
Safety and tolerability
Time frame: 1 year (anticipated
Response rate
Time frame: 1 year (anticipated)
4 secondary outcomes
Progression-free survival
Time frame: 1 year (anticipated)
Duration of objective response
Time frame: 1 year (anticipated)
Pharmacokinetics
Time frame: 1 year (anticipated)
Pharmacodynamics
Time frame: 1 year (anticipated)
Results and safety
The study was stopped early (reason given: The Clinical Development Program for MGCD0103 is being re-evaluated). Results are not available in the source record.
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.
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 MGCD0103 in people with Myelogenous Leukemia, Acute and Myelodysplastic Syndromes, run by Mirati Therapeutics Inc. 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 9 inclusion and 8 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: stopped early, 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 13 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 was stopped early (reason given: The Clinical Development Program for MGCD0103 is being re-evaluated). Results are not available in the source record.
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?
Safety and tolerability (time frame: 1 year (anticipated). The study lists 2 primary outcomes in all. 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.