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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-01353 | Registry Identifier | NCI CTRP |
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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The goal of this clinical research study is to learn if dasatinib can help to control myeloproliferative disorders. The safety and tolerability of dasatinib will also be studied.
Dasatinib is an experimental anti-cancer drug that is designed to block the function of BCR-ABL, which is the abnormal protein responsible for causing leukemia in some cells.
If you are found to be eligible to take part in this study, you will take dasatinib by mouth twice a day. If you have mastocytosis, you will take dasatinib by mouth once a day. A treatment cycle will be defined as 4 weeks (28 days) + 7 days. You will be instructed to take dasatinib in the morning (between about 6:00 a.m.-10:00 a.m.) and in the evening (between about 6:00 p.m.-10:00 p.m.).
Blood tests (about 2 - 3 teaspoons) will be done once a week for a month, then once a month for 5 years, then once every 6 months (if your doctor thinks it is needed) for the remainder of your treatment on this study. A bone marrow biopsy will be done after 1-2 months of therapy to document response.
Dasatinib will be given for as long as you are responding. You will be taken off study if the disease gets worse or intolerable side effects occur.
This is an investigational study. Dasatinib is authorized for use in research only. A total of 145 patients will take part in this study. All will be treated at MD Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute myeloid leukemia (AML) | Experimental | Dasatinib 70 mg orally twice daily. |
|
| MDS/CMML | Experimental | Dasatinib 70 mg orally twice daily. |
|
| HES/CEL | Experimental | Dasatinib 70 mg orally twice daily. |
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| Primary myelofibrosis (PMF) | Experimental | Dasatinib 70 mg orally twice daily. |
|
| Systemic Mastocytosis (SM) | Experimental | Dasatinib 70 mg orally twice daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dasatinib (BMS-354825) | Drug | 70 mg orally twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant Response Rate | Response Rate is complete response plus partial response (CR+PR) for each disease category. Response Evaluation Criteria are as follows: Systemic Mastocytosis (SM): CR is the improvement of C-Findings, Tryptase <20, and no organomegaly. PR is the improvement of C-Findings. Acute Myeloid Leukemia (AML)/MDS and CMML: CR is bone marrow blasts </= 5%, absolute neutrophil count (ANC) >/= 1000 and platelets >/= 100. PR is bone marrow blasts 6-25% but decreased by > 50% and absolute neutrophil count, absolute neutrophil count (ANC) >/= 1000 and platelets >/= 100. Primary Myelofibrosis (PMF): CR is bone marrow blasts </= 5%, absolute neutrophil count (ANC) >/= 1000 and platelets >/= 100. CR is PR plus one or more of the following: ANC >/= 1000, decreased platelets by 50%, hemoglobin increase of 2g/dl or reduction splenomegaly and/or hepatomegaly by 50%. HES/CEL: CR is disappearance of eosinophilia </= 10%, PR is reduction of eosinophilia by >/= 50% | Baseline to completion of 4 week cycle or until disease progression |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (Survival) | Response date to loss of response or last follow up. | Baseline, once a week for a month, thereafter monthly, up to 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hagop M Kantarjian, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas M.D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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Sixty-Seven participants were registered and received the study medication for this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Acute Myeloid Leukemia (AML) | Dasatinib 70 mg orally twice daily. Dasatinib (BMS-354825): 70 mg orally twice daily |
| FG001 | MDS/CMML | Dasatinib 70 mg orally twice daily. Dasatinib (BMS-354825): 70 mg orally twice daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 18, 2011 |
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| FG002 | HES/CEL | Dasatinib 70 mg orally twice daily. Dasatinib (BMS-354825): 70 mg orally twice daily |
| FG003 | Primary Myelofibrosis (PMF) | Dasatinib 70 mg orally twice daily. Dasatinib (BMS-354825): 70 mg orally twice daily |
| FG004 | Systemic Mastocytosis (SM) | Dasatinib 70 mg orally twice daily. Dasatinib (BMS-354825): 70 mg orally twice daily |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Acute Myeloid Leukemia (AML) | Dasatinib 70 mg orally twice daily. Dasatinib (BMS-354825): 70 mg orally twice daily |
| BG001 | MDS/CMML | Dasatinib 70 mg orally twice daily. Dasatinib (BMS-354825): 70 mg orally twice daily |
| BG002 | HES/CEL | Dasatinib 70 mg orally twice daily. Dasatinib (BMS-354825): 70 mg orally twice daily |
| BG003 | Primary Myelofibrosis (PMF) | Dasatinib 70 mg orally twice daily. Dasatinib (BMS-354825): 70 mg orally twice daily |
| BG004 | Systemic Mastocytosis (SM) | Dasatinib 70 mg orally twice daily. Dasatinib (BMS-354825): 70 mg orally twice daily |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participant Response Rate | Response Rate is complete response plus partial response (CR+PR) for each disease category. Response Evaluation Criteria are as follows: Systemic Mastocytosis (SM): CR is the improvement of C-Findings, Tryptase <20, and no organomegaly. PR is the improvement of C-Findings. Acute Myeloid Leukemia (AML)/MDS and CMML: CR is bone marrow blasts </= 5%, absolute neutrophil count (ANC) >/= 1000 and platelets >/= 100. PR is bone marrow blasts 6-25% but decreased by > 50% and absolute neutrophil count, absolute neutrophil count (ANC) >/= 1000 and platelets >/= 100. Primary Myelofibrosis (PMF): CR is bone marrow blasts </= 5%, absolute neutrophil count (ANC) >/= 1000 and platelets >/= 100. CR is PR plus one or more of the following: ANC >/= 1000, decreased platelets by 50%, hemoglobin increase of 2g/dl or reduction splenomegaly and/or hepatomegaly by 50%. HES/CEL: CR is disappearance of eosinophilia </= 10%, PR is reduction of eosinophilia by >/= 50% | Posted | Count of Participants | Participants | Baseline to completion of 4 week cycle or until disease progression |
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| Secondary | Duration of Response (Survival) | Response date to loss of response or last follow up. | The number of participants analyzed for duration of response reflects the number of participants with a response for each arm. | Posted | Mean | Full Range | Months | Baseline, once a week for a month, thereafter monthly, up to 10 years |
|
Through study completion, up to 10 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dasatinib All Patient Groups | Dasatinib 70 mg orally twice daily. Dasatinib (BMS-354825): 70 mg orally twice daily | 2 | 68 | 2 | 68 | 67 | 68 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pericardial Effusion | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage CNS | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Skin Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Edema | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Headache | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea/Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Platelets/Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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The outcome measures were collected and reported by participant diagnosis group. The Other Adverse Events and Serious Adverse Events were collected and recorded as a group for all participants registered on the study.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hagop Kantarjian, MD/Department Chair | The University of Texas MD Anderson Cancer Center | 713-792-7026 | hkantarjian@mdanderson.org |
| Apr 9, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009190 | Myelodysplastic Syndromes |
| D055728 | Primary Myelofibrosis |
| D017681 | Hypereosinophilic Syndrome |
| D011087 | Polycythemia Vera |
| D008415 | Mastocytosis |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
| D009196 | Myeloproliferative Disorders |
| D004802 | Eosinophilia |
| D007960 | Leukocyte Disorders |
| D019046 | Bone Marrow Neoplasms |
| D019337 | Hematologic Neoplasms |
| D009371 | Neoplasms by Site |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D000090362 | Mast Cell Activation Disorders |
| D007154 | Immune System Diseases |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069439 | Dasatinib |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
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| Between 18 and 65 years |
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| >=65 years |
|
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|
| Systemic Mastocytosis (SM) |
Dasatinib 70 mg orally twice daily. Dasatinib (BMS-354825): 70 mg orally twice daily |
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