Multiple Indications CancerPhase 2NCT02297139
Continuing Treatment for Subjects Who Have Participated on a Prior Protocol Investigating Dasatinib
A Phase 2 study testing Dasatinib in people with Multiple Indications Cancer, run by Bristol-Myers Squibb at 6 sites in 2 countries.
Trial summary
The purpose of this study is to continue to provide dasatinib to patients that are currently participating in another dasatinib trial that is ending and for which there is no other option to provide dasatinib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Indications Cancer
- What is being tested?
- Dasatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 31 Jul 2015to 15 May 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Participated in and completed a previous dasatinib protocol (including but not limited to CA180056, CA180363 or CA180227) and is deemed by the investigator to be deriving benefit from dasatinib as defined by the previous protocol
- Receiving dasatinib at the time of signature of informed consent
- Males and Females, ages 18 and older
Who cannot join
- All patients previously discontinued from a dasatinib study for any reason
- Any serious or uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy
- History of allergy to dasatinib
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Poland5 sites
Local Institution
Chorzów, 41-500
Local Institution - 0006
Krakow, Lesser Poland Voivodeship, 30-727
Local Institution
Lodz, 93-510
Local Institution - 0003
Warsaw, 02776
Local Institution - 0002
Wroclaw, 50-367
About this study
The purpose of this study is to continue to provide dasatinib to patients that are currently participating in another dasatinib trial that is ending and for which there is no other option to provide dasatinib.
- Conditions
- Multiple Indications Cancer
- Being tested
- Dasatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasatinibDrug
| Study group | Role | What they receive |
|---|---|---|
| Dasatinib | Experimental | This is a continuation roll-over study for patients receiving benefit from prior dasatinib protocols. All subjects will receive dasatinib as per previous protocol Receives: Drug: Dasatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Received Dasatinib Treatment
Number of participants who received dasatinib treatment for prostate cancer and chronic phase chronic myeloid leukemia who had also participated on prior protocols CA180-227, CA180-363 and CA180-056 investigating dasatinib. Dasatinib tablet administered once a day by mouth.
Measured: From first dose on this study (CA180-597) to last dose on this study (up to approximately 76 months)
Duration of Treatment
Duration of treatment for participants who received dasatinib treatment for prostate cancer and chronic phase chronic myeloid leukemia who had also participated on prior protocols CA180-227, CA180-363 and CA180-056 investigating dasatinib. Dasatinib tablet administered once a day by mouth.
Measured: From first dose on this study (CA180-597) to last dose on this study (up to approximately 76 months)
Secondary outcomes (2)
Number of Participants With Adverse Events
Number of Participants with Adverse Events (AEs). An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
Measured: From first dose on this study (CA180-597) to 30 days after last dose of study therapy (up to approximately 77 months)
Number of Participants With Serious Adverse Events
Number of participants with serious adverse events (SAEs). SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
Measured: From first dose on this study (CA180-597) to 30 days after last dose of study therapy (up to approximately 77 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study start31 Jul 2015
- Primary completion15 May 2022
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple Indications CancerStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02297139
- Sponsor's protocol ID
- CA180-597
- Status last verified
- Apr 2023
- First submitted
- 19 Nov 2014
- Last updated
- 6 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuing Treatment for Subjects Who Have Participated on a Prior Protocol Investigating Dasatinib
- ClinicalTrials.gov ID
- NCT02297139
- Acronym / sponsor ID
- CA180-597
- Conditions
- Multiple Indications Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2015 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 21 Nov 2014 (estimated)
- Results
- Posted 6 May 2023
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 continue to provide dasatinib to patients that are currently participating in another dasatinib trial that is ending and for which there is no other option to provide dasatinib.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dasatinib | Experimental | Drug: DasatinibThis is a continuation roll-over study for patients receiving benefit from prior dasatinib protocols. All subjects will receive dasatinib as per previous protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participated in and completed a previous dasatinib protocol (including but not limited to CA180056, CA180363 or CA180227) and is deemed by the investigator to be deriving benefit from dasatinib as defined by the previous protocol
- Receiving dasatinib at the time of signature of informed consent
- Males and Females, ages 18 and older
Key exclusion criteria (3 listed)
- All patients previously discontinued from a dasatinib study for any reason
- Any serious or uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy
- History of allergy to dasatinib
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 | Drug | Dasatinib |
Primary outcome
Number of Participants Who Received Dasatinib Treatment
Time frame: From first dose on this study (CA180-597) to last dose on this study (up to approximately 76 months)
Number of participants who received dasatinib treatment for prostate cancer and chronic phase chronic myeloid leukemia who had also participated on prior protocols CA180-227, CA180-363 and CA180-056 investigating dasatinib. Dasatinib tablet administered once a day by mouth.
Duration of Treatment
Time frame: From first dose on this study (CA180-597) to last dose on this study (up to approximately 76 months)
Duration of treatment for participants who received dasatinib treatment for prostate cancer and chronic phase chronic myeloid leukemia who had also participated on prior protocols CA180-227, CA180-363 and CA180-056 investigating dasatinib. Dasatinib tablet administered once a day by mouth.
2 secondary outcomes
Number of Participants With Adverse Events
Time frame: From first dose on this study (CA180-597) to 30 days after last dose of study therapy (up to approximately 77 months)
Number of Participants With Serious Adverse Events
Time frame: From first dose on this study (CA180-597) to 30 days after last dose of study therapy (up to approximately 77 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
6 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 Dasatinib in people with Multiple Indications Cancer, run by Bristol-Myers Squibb at 6 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 3 inclusion and 3 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 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Poland, France. 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?
Yes. Results are posted in the registry (first posted 6 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Received Dasatinib Treatment (time frame: From first dose on this study (CA180-597) to last dose on this study (up to approximately 76 months)). 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 6 May 2023.