Myeloid Leukemia, Chronic, Chronic-PhasePhase 1NCT00324077
Phase I Study of Dasatinib (BMS-354825) and Imatinib in Subjects With Chronic Myeloid Leukemia in Chronic Phase
A Phase 1 study testing Dasatinib in combination with imatinib in people with Myeloid Leukemia, Chronic, Chronic-Phase, run by Bristol-Myers Squibb at 3 sites in United States.
Trial summary
The purpose of this study is to find out whether adding a new drug, dasatinib, to imatinib is safe, and whether the combination of the two drugs will help decrease the number of cells that contain the Philadelphia chromosome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloid Leukemia, Chronic, Chronic-Phase
- What is being tested?
- Dasatinib in combination with imatinib
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2006to Feb 2007
- 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
- Adult, Older adult
Who may be able to join
- males and females, 18 or older
- chronic phase Ph+ or BCR-ABL positive CML
- current complete hematologic response to imatinib
- lack of major molecular response
- on imatinib for at least one year
- on the same imatinib dose for at least 6 months
- adequate hepatic and renal function
Who cannot join
- History of accelerated or blast phase CML
- Serious uncontrolled medical disorder or active infection
- Significant cardiovascular disease or bleeding disorder
- Concurrent use of medications at risk of causing Torsades de Pointe
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Local Institution
Los Angeles, California
Local Institution
New York, New York
Local Institution
San Francisco, California
About this study
Official title: A Phase I Dose Escalation Study of the Combination of Dasatinib (BMS-354825) and Imatinib in Subjects With Chronic Myeloid Leukemia in Chronic Phase
The purpose of this study is to find out whether adding a new drug, dasatinib, to imatinib is safe, and whether the combination of the two drugs will help decrease the number of cells that contain the Philadelphia chromosome.
- Conditions
- Myeloid Leukemia, Chronic, Chronic-Phase
- Being tested
- Dasatinib in combination with imatinib
- Keywords
- Chronic phase chronic myelogenous leukemia (CML)
- Medical subject headings
- Leukemia, Myeloid, Chronic-Phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dasatinib in combination with imatinibDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum tolerated dose (MTD) and recommended dose of dasatinib when combined with imatinib in chronic phase CML patients.
Secondary outcomes (7)
assess safety and tolerability of dasatinib and imatinib administered in combination throughout study
identify dose limiting toxicities
characterize plasma pharmacokinetics of dasatinib and imatinib in month 1
measure major molecular response rate
measure the major cytogenetic response rate
characterize mutations in the BCR-ABL gene
evaluate progressive free survival and overall survival
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 startAug 2006
- Primary completionFeb 2007
Why it stopped: Insufficient Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloid Leukemia, Chronic, Chronic-PhaseStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00324077
- Sponsor's protocol ID
- CA180-011
- Status last verified
- Apr 2011
- First submitted
- 9 May 2006
- Last updated
- 17 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalation Study of the Combination of Dasatinib (BMS-354825) and Imatinib in Subjects With Chronic Myeloid Leukemia in Chronic Phase
- ClinicalTrials.gov ID
- NCT00324077
- Acronym / sponsor ID
- CA180-011
- Conditions
- Myeloid Leukemia, Chronic, Chronic-Phase
- Keywords
- Chronic phase chronic myelogenous leukemia (CML)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient Enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Feb 2007 (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.
The purpose of this study is to find out whether adding a new drug, dasatinib, to imatinib is safe, and whether the combination of the two drugs will help decrease the number of cells that contain the Philadelphia chromosome.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- males and females, 18 or older
- chronic phase Ph+ or BCR-ABL positive CML
- current complete hematologic response to imatinib
- lack of major molecular response
- on imatinib for at least one year
Key exclusion criteria (4 listed)
- History of accelerated or blast phase CML
- Serious uncontrolled medical disorder or active infection
- Significant cardiovascular disease or bleeding disorder
- Concurrent use of medications at risk of causing Torsades de Pointe
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 |
|---|---|---|
| Dasatinib in combination with imatinib | Drug | – |
Primary outcome
To determine the maximum tolerated dose (MTD) and recommended dose of dasatinib when combined with imatinib in chronic phase CML patients.
7 secondary outcomes
assess safety and tolerability of dasatinib and imatinib administered in combination throughout study
identify dose limiting toxicities
characterize plasma pharmacokinetics of dasatinib and imatinib in month 1
measure major molecular response rate
measure the major cytogenetic response rate
characterize mutations in the BCR-ABL gene
evaluate progressive free survival and overall survival
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 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.
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 Dasatinib in combination with imatinib in people with Myeloid Leukemia, Chronic, Chronic-Phase, run by Bristol-Myers Squibb 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 7 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: withdrawn, as of the sponsor's last update on 17 Feb 2016. 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 withdrawn before enrolling participants, so there are no results.
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?
To determine the maximum tolerated dose (MTD) and recommended dose of dasatinib when combined with imatinib in chronic phase CML patients.. 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 17 Feb 2016.