Myelodysplastic SyndromePhase 1NCT00282399
A Clinical Trial of Decitabine in Patients With Myelodysplastic Syndrome
A Phase 1 study testing Subcutaneous Decitabine in people with Myelodysplastic Syndrome, run by Eisai Inc. at 3 sites in United States.
Trial summary
The purpose of this study was to determine which of the doses of decitabine maximizes genomic demethylation in patients with Myelodysplastic Syndrome (MDS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndrome
- What is being tested?
- Subcutaneous Decitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2006to Feb 2009
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Confirmed diagnosis of MDS or non-proliferative chronic myelomonocytic leukemia (CMML).
Who cannot join
- Prior therapy with decitabine or azacytidine (Vidaza).
- Experimental or standard drugs for the treatment of MDS within 28 days of the first day of study drug treatment.
- Clinically significant anemia.
- Prior history of malignancy other than MDS.
- Any active infection.
- Radiotherapy within 14 days prior to study enrollment.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
H Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
Albert Einstein College of Medicine
The Bronx, New York, 10461
University of Arizona Cancer Center
Tucson, Arizona, 85724
About this study
Official title: Phase I/II Trial of Subcutaneous Decitabine Maximizing Genomic Demethylation in Patients With Myelodysplastic Syndrome.
The purpose of this study was to determine which of the doses of decitabine maximizes genomic demethylation in patients with Myelodysplastic Syndrome (MDS).
Read the detailed description
Phase I: The purpose of this study was to determine which of the subcutaneous doses of decitabine administered twice daily for 5 days maximizes genomic demethylation in patients with MDS
Phase II: To evaluate hematological responses at the dose selected in the Phase I portion of the study.
Note: This study was planned as Phase 1/2 study but only the Phase 1 part was conducted due to a change in product development strategy
- Conditions
- Myelodysplastic Syndrome
- Being tested
- Subcutaneous Decitabine
- Keywords
- Myelodysplastic Syndrome, MGI Pharma, Decitabine, Dacogen
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous DecitabineDrug
| Study group | Role | What they receive |
|---|---|---|
| DACO-019 2mg/m^2 | Experimental | DACO-019 2mg/m^2 twice daily (BID) Receives: Drug: Subcutaneous Decitabine |
| DACO-019 5mg/m^2 | Experimental | DACO-019 5mg/m^2 BID Receives: Drug: Subcutaneous Decitabine |
| DACO-019 10mg/m^2 | Experimental | DACO-019 10mg/m^2 BID Receives: Drug: Subcutaneous Decitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: To determine which of the subcutaneous (SQ) doses of decitabine administered twice daily for 5 days maximizes genomic demethylation in patients with MDS.
Measured: Up to 8 cycles (224 days)
Phase II: To evaluate hematological response at the dose selected in the Phase I portion of the study.
Measured: Up to 12 cycles (336 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2006 (estimated)
- Study startOct 2006
- Primary completionOct 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromeStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00282399
- Sponsor's protocol ID
- DACO-019
- Status last verified
- Oct 2015
- First submitted
- 25 Jan 2006
- Last updated
- 28 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Trial of Subcutaneous Decitabine Maximizing Genomic Demethylation in Patients With Myelodysplastic Syndrome.
- ClinicalTrials.gov ID
- NCT00282399
- Acronym / sponsor ID
- DACO-019
- Conditions
- Myelodysplastic Syndrome
- Keywords
- Myelodysplastic Syndrome, MGI Pharma, Decitabine, Dacogen
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 26 Jan 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.
The purpose of this study was to determine which of the doses of decitabine maximizes genomic demethylation in patients with Myelodysplastic Syndrome (MDS).
Detailed description
Phase I: The purpose of this study was to determine which of the subcutaneous doses of decitabine administered twice daily for 5 days maximizes genomic demethylation in patients with MDS
Phase II: To evaluate hematological responses at the dose selected in the Phase I portion of the study.
Note: This study was planned as Phase 1/2 study but only the Phase 1 part was conducted due to a change in product development strategy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DACO-019 2mg/m^2 | Experimental | Drug: Subcutaneous DecitabineDACO-019 2mg/m^2 twice daily (BID) |
| DACO-019 5mg/m^2 | Experimental | Drug: Subcutaneous DecitabineDACO-019 5mg/m^2 BID |
| DACO-019 10mg/m^2 | Experimental | Drug: Subcutaneous DecitabineDACO-019 10mg/m^2 BID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Confirmed diagnosis of MDS or non-proliferative chronic myelomonocytic leukemia (CMML).
Key exclusion criteria (6 listed)
- Prior therapy with decitabine or azacytidine (Vidaza).
- Experimental or standard drugs for the treatment of MDS within 28 days of the first day of study drug treatment.
- Clinically significant anemia.
- Prior history of malignancy other than MDS.
- Any active infection.
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 |
|---|---|---|
| Subcutaneous Decitabine | Drug | DACO-019 10mg/m^2, DACO-019 2mg/m^2, DACO-019 5mg/m^2 |
Primary outcome
Phase I: To determine which of the subcutaneous (SQ) doses of decitabine administered twice daily for 5 days maximizes genomic demethylation in patients with MDS.
Time frame: Up to 8 cycles (224 days)
Phase II: To evaluate hematological response at the dose selected in the Phase I portion of the study.
Time frame: Up to 12 cycles (336 days)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2015.
- MGI PHARMA's official websiteLink provided by the sponsor.
Related trials for Myelodysplastic Syndrome
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Active, not recruitingPhase 1/2
Omacetaxine + Azacitidine in Untreated Patients With High Grade MDS
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Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
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ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Subcutaneous Decitabine in people with Myelodysplastic Syndrome, run by Eisai Inc. at 3 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 2 inclusion and 6 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 28 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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 was stopped early. 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?
Phase I: To determine which of the subcutaneous (SQ) doses of decitabine administered twice daily for 5 days maximizes genomic demethylation in patients with MDS. (time frame: Up to 8 cycles (224 days)). 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 28 Oct 2015.