LeukemiaPhase 1NCT00324194
A Phase I Study of MGCD0103 Given Twice Weekly in Patients With Leukemia or Myelodysplastic Syndromes
A Phase 1 study testing MGCD0103 in people with Leukemia and Myelodysplastic Syndromes, run by Mirati Therapeutics Inc. at 4 sites in 2 countries.
Trial summary
In this study, MGCD0103, a new anticancer drug under investigation, is given twice weekly to patients with leukemia or myelodysplastic syndromes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, 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
- 25 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Feb 2005to Aug 2008
- Phase
- Phase 1
- 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
- Patients must have a diagnosis of one of the following:
- relapsed or refractory AML or ALL that has failed to respond to standard therapy, has progressed despite standard therapy.
- relapsed or refractory Myelodysplastic Syndromes including CMML (chronic myelomonocytic leukemia) or other myeloproliferative disorders provided there is an MDS component.
- previously untreated AML or Myelodysplastic Syndromes in patients >60 years of age who refused or are not candidates for induction chemotherapy
- Patients with relapsed or refractory CML that has failed to respond to imatinib therapy or standard therapy, has progressed despite standard therapy, or for which no standard therapy exists.
- ECOG performance status of 0, 1, or 2.
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- Age ≥18 years.
- Laboratory requirements.
- Patients or their legal representative must be able to read, understand, and sign a written informed consent (approved by the IRB/EC) prior to study entry.
Who cannot join
- Patients with other active malignancy except basal cell carcinoma or cervical intraepithelial neoplasia (CIN / cervical in situ).
- Patients with suspicion of CNS involvement (tests are not required to rule out CNS involvement in the absence of signs or symptoms).
- Pregnant or lactating women. Women of child-bearing potential must have a negative serum pregnancy test documented within 7 days prior to registration on study.
- Patients and their partners, if either are of childbearing potential, not using adequate birth control measures throughout the course of the study. Both men and women enrolled on study must agree to use a medically acceptable effective form of contraception during the study and for 90 days following the last dose of study medication. An effective form of contraception is an oral contraceptive or a double barrier method, such as condom with diaphragm.
- Patients with serious illnesses, medical conditions, or other medical history, including laboratory results, which, in the investigator's opinion, would be likely to interfere with a patient's participation in the study, or with the interpretation of the results.
- Patients who have been treated with any investigational drug within 30 days prior to study initiation (an investigational drug is one for which there is no approved indication), or who are receiving concurrent treatment with other experimental drugs or anti-cancer therapy.
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- Known hypersensitivity to any of the components of MGCD0103.
- Known HIV or Hepatitis B or C (tests do not need to be performed to rule out any of these infections).
- Any psychiatric illness/social situations that would, in the judgment of the investigator, limit compliance with study requirements.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
University of Chicago Medical Center
Chicago, Illinois, 60637
Columbia University Medical Center
New York, New York, 10032
Lee Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: A Phase I Study of MGCD0103 Given as a Twice Weekly Oral Dose in Patients With Leukemia or Myelodysplastic Syndromes
In this study, MGCD0103, a new anticancer drug under investigation, is given twice weekly to patients with leukemia or myelodysplastic syndromes.
- Conditions
- Leukemia, Myelodysplastic Syndromes
- Being tested
- MGCD0103
- Keywords
- Leukemia, Myelodysplastic Syndromes, Phase I
- Medical subject headings
- Leukemia, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGCD0103Drug
MGCD0103 oral dose given 2 times per week.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MGCD0103 oral dose 2 times per week. 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)
Secondary outcomes (4)
Clinical response.
Measured: 1 year (anticipated)
Dose limiting toxicities
Measured: 1 year (anticipated)
Pharmacokinetics
Measured: 1 year (anticipated)
Pharmacodynamics (histone acetylation, biomarkers)
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 posted10 May 2006 (estimated)
- Study startFeb 2005
- Primary completionMar 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mirati Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gregory Reid, MSc, MBA, Study director, MethylGene Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00324194
- Sponsor's protocol ID
- 0103-004
- Status last verified
- Jan 2015
- First submitted
- 8 May 2006
- Last updated
- 8 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of MGCD0103 Given as a Twice Weekly Oral Dose in Patients With Leukemia or Myelodysplastic Syndromes
- ClinicalTrials.gov ID
- NCT00324194
- Acronym / sponsor ID
- 0103-004
- Conditions
- Leukemia, Myelodysplastic Syndromes
- Keywords
- Leukemia, Myelodysplastic Syndromes, Phase I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Mirati Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2005
- Primary completion
- Mar 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 10 May 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 twice weekly to patients with leukemia or myelodysplastic syndromes.
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: MGCD0103MGCD0103 oral dose 2 times per week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must have a diagnosis of one of the following:
- ECOG performance status of 0, 1, or 2.
- Age ≥18 years.
- Laboratory requirements.
- Patients or their legal representative must be able to read, understand, and sign a written informed consent (approved by the IRB/EC) prior to study entry.
Key exclusion criteria (9 listed)
- Patients with other active malignancy except basal cell carcinoma or cervical intraepithelial neoplasia (CIN / cervical in situ).
- Patients with suspicion of CNS involvement (tests are not required to rule out CNS involvement in the absence of signs or symptoms).
- Pregnant or lactating women. Women of child-bearing potential must have a negative serum pregnancy test documented within 7 days prior to registration on study.
- Patients and their partners, if either are of childbearing potential, not using adequate birth control measures throughout the course of the study. Both men and women enrolled on study must agree to use a medically acceptable effective form of contraception during the study and for 90 days following the last dose of study medication. An effective form of contraception is an oral contraceptive or a double barrier method, such as condom with diaphragm.
- Patients with serious illnesses, medical conditions, or other medical history, including laboratory results, which, in the investigator's opinion, would be likely to interfere with a patient's participation in the study, or with the interpretation of the results.
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 oral dose given 2 times per week. | Drug | 1 |
Primary outcome
Safety and tolerability.
Time frame: 1 year (anticipated)
4 secondary outcomes
Clinical response.
Time frame: 1 year (anticipated)
Dose limiting toxicities
Time frame: 1 year (anticipated)
Pharmacokinetics
Time frame: 1 year (anticipated)
Pharmacodynamics (histone acetylation, biomarkers)
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 8 Jan 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.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MGCD0103 in people with Leukemia and Myelodysplastic Syndromes, run by Mirati Therapeutics Inc. at 4 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 9 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 8 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 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.
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?
Safety and tolerability. (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 8 Jan 2015.