A Phase 2 interventional study of Dasatinib in Multiple Indications Cancer, sponsored by Bristol-Myers Squibb. Completed at 6 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-06.
Sponsored by Bristol-Myers Squibb · Phase 2, Interventional, and Supportive care
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.
Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
This is a continuation roll-over study for patients receiving benefit from prior dasatinib protocols. All subjects will receive dasatinib as per previous protocol
Drug: Dasatinib
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.
Time frame: 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.
Time frame: From first dose on this study (CA180-597) to last dose on this study (up to approximately 76 months)
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.
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
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.
Time frame: From first dose on this study (CA180-597) to 30 days after last dose of study therapy (up to approximately 77 months)
| Milestone | Prostate Cancer | Chronic Phase - Chronic Myeloid Leukemia (CP-CML) |
|---|---|---|
| Started | 1 | 16 |
| Completed | 0 | 0 |
| Not completed | 1 | 16 |
| Withdrew: Disease progression | 0 | 1 |
| Withdrew: Study drug toxicity | 0 | 4 |
| Withdrew: Participant request to discontinue study treatment | 0 | 1 |
| Withdrew: Maximum clinical benefit | 1 | 0 |
| Withdrew: Administrative reason by sponsor | 0 | 2 |
| Withdrew: Other reasons | 0 | 8 |
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.
| Participants | Prostate Cancer | Chronic Phase - Chronic Myeloid Leukemia (CP-CML) |
|---|---|---|
| Number of Participants Who Received Dasatinib Treatment | 1 | 16 |
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.
| Months | Prostate Cancer | Chronic Phase - Chronic Myeloid Leukemia (CP-CML) |
|---|---|---|
| Duration of Treatment | 25.3 (25.3 to 25.3) | 55.9 (4.0 to 75.5) |
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.
| Participants | Prostate Cancer | Chronic Phase - Chronic Myeloid Leukemia (CP-CML) |
|---|---|---|
| Number of Participants With Adverse Events | 1 | 15 |
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.
| Participants | Prostate Cancer | Chronic Phase - Chronic Myeloid Leukemia (CP-CML) |
|---|---|---|
| Number of Participants With Serious Adverse Events | 0 | 8 |
Collected over Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 82 months). SAEs and other AEs were assessed from first dose to 30 days after last dose of study therapy (up to approximately 77 months).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prostate Cancer | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Chronic Phase - Chronic Myeloid Leukemia (CP-CML) | 1/16 (6.3%) | 8/16 (50%) | 15/16 (93.8%) |
| Event | Prostate Cancer | Chronic Phase - Chronic Myeloid Leukemia (CP-CML) |
|---|---|---|
| Cardiac failureCardiac disorders | 0/1 | 2/16 |
| PyrexiaGeneral disorders | 0/1 | 2/16 |
| PneumoniaInfections and infestations | 0/1 | 2/16 |
| HydrothoraxRespiratory, thoracic and mediastinal disorders | 0/1 | 2/16 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 0/1 | 2/16 |
| Atrial fibrillationCardiac disorders | 0/1 | 1/16 |
| Non-cardiac chest painGeneral disorders | 0/1 | 1/16 |
| Drug hypersensitivityImmune system disorders | 0/1 | 1/16 |
| Thyroid neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/1 | 1/16 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 0/1 | 1/16 |
| Event | Prostate Cancer | Chronic Phase - Chronic Myeloid Leukemia (CP-CML) |
|---|---|---|
| Blood testosterone increasedInvestigations | 1/1 | 0/16 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 0/1 | 6/16 |
| HypertensionVascular disorders | 0/1 | 6/16 |
| Upper respiratory tract infectionInfections and infestations | 0/1 | 4/16 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/1 | 4/16 |
| AnaemiaBlood and lymphatic system disorders | 0/1 | 3/16 |
| PyrexiaGeneral disorders | 0/1 | 3/16 |
| AstheniaGeneral disorders | 0/1 | 2/16 |
| PneumoniaInfections and infestations | 0/1 | 2/16 |
| Urinary tract infectionInfections and infestations | 0/1 | 2/16 |
| Age, Continuous(Years) | Prostate Cancer | Chronic Phase - Chronic Myeloid Leukemia (CP-CML) | Total |
|---|---|---|---|
| Median | 58 (58 to 58) | 64.5 (35 to 75) | 62 (35 to 75) |
| Sex: Female, Male(Participants) | Prostate Cancer | Chronic Phase - Chronic Myeloid Leukemia (CP-CML) | Total |
|---|---|---|---|
| Female | 0 | 8 | 8 |
| Male | 1 | 8 | 9 |
| Ethnicity (NIH/OMB)(Participants) | Prostate Cancer | Chronic Phase - Chronic Myeloid Leukemia (CP-CML) | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 0 | 15 | 15 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Race (NIH/OMB)(Participants) | Prostate Cancer | Chronic Phase - Chronic Myeloid Leukemia (CP-CML) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 16 | 16 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 |
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Bristol-Myers Squibb