Chondrosarcoma, Chordoma, Epithelioid Sarcoma, Gastrointestinal Stromal Tumor (GIST), Giant Cell Tumor of Bone, Hemangiopericytoma, Malignant Peripheral Nerve Sheath Tumors, Rhabdomyosarcoma, Sarcoma, Alveolar Soft Part, Sarcoma, Ewing's
Conditions
Keywords
Dasatinib, Rhabdomyosarcoma, Malignant peripheral nerve sheath tumor, Chondrosarcoma, Ewing's, Alveolar soft part sarcoma (ASPS), Chordoma, Epithelioid sarcoma, Giant cell tumor of bone, Hemangiopericytoma/solitary fibrous tumor, Gastrointestinal Stromal Tumor (GIST)
Brief summary
This study will examine the response rate and the 6-month progression-free survival rates of subjects with advanced sarcoma treated with dasatinib.
Detailed description
Further details provided by SARC (Sarcoma Alliance for Research through Collaboration): Treatment: Subjects take Dasatinib twice daily by mouth for 28 days per 28 day cycle. Subjects will be seen for interim medical history, physical exam and laboratory studies prior to each cycle. Subjects will undergo tumor imaging every 2 months (8 weeks) for the first 6 months and approximately every 3 months thereafter while on treatment. A blood sample for collection of specimens with which to later study serum level of Dasatinib and effects on biomarkers of drug activity will be obtained approximately 2 to 4 weeks after the start of treatment. Central collection of archival tumor with which to later study the frequency of expression and/or mutation of kinases inhibited by dasatinib will occur. Subjects will be followed for approximately every 3 months until 2 years from registration and then approximately yearly until 5 years from registration.
Interventions
DRUGDasatinib
oral agent, continuous dosing, Cycles = 28 days
Sponsors
Bristol-Myers Squibb
Sarcoma Alliance for Research through Collaboration
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Unresectable, recurrent, or metastatic histologically-confirmed soft tissue or bone sarcoma of one of the following subtypes: * Leiomyosarcoma --\* NO LONGER ELIGIBLE\* * Liposarcoma--\* NO LONGER ELIGIBLE\* * Malignant fibrous histiocytoma (MFH)/pleomorphic undifferentiated sarcoma--\* NO LONGER ELIGIBLE\* * Rhabdomyosarcoma --\* NO LONGER ELIGIBLE\* * Malignant peripheral nerve sheath tumor (MPNST) --\* NO LONGER ELIGIBLE\* * Osteosarcoma (skeletal or extraosseous)--\* NO LONGER ELIGIBLE\* * Ewing's --\* NO LONGER ELIGIBLE\* * Chondrosarcoma * Alveolar soft part sarcoma * Chordoma * Epithelioid sarcoma * Giant cell tumor of bone * Hemangiopericytoma/solitary fibrous tumor * Gastrointestinal Stromal Tumor (GIST) --\* NO LONGER ELIGIBLE\* 2. Documentation that subjects with leiomyosarcoma, liposarcoma, osteosarcoma, Ewing's, MPNST, rhabdomyosarcoma or MFH have received, not been eligible for or refused at least one prior chemotherapy regimen before participation in the dasatinib study. Subjects with GIST must have received or been intolerant to imatinib; prior treatment with other agents including sunitinib is not required.Neoadjuvant/adjuvant chemotherapy qualifies as prior therapy. 3. Subjects must have unidimensionally measurable lesion(s) either by x-ray, computed tomography (CT), magnetic resonance imaging (MRI) or physical examination documented within 30 days prior to registration. 4. Prior radiation will be allowed. More than two weeks should have elapsed since the administration of the last fraction of radiation therapy, and subjects must have recovered from grade 2 or higher associated toxicities. Measurable lesions, which are selected as target lesions, must be outside previously radiated fields or have documented progression no sooner than 6 weeks after completion of radiation. 5. More than 2 weeks must have elapsed since the subject has received any prior systemic chemotherapy (6 weeks for mitomycin C), and the patient should have recovered from toxicities to the baseline prior to the last course of chemotherapy. 6. Adequate hematologic function within 14 days prior to registration. 7. Prothrombin Time (PT) (or INR) and Partial Thromboplastin Time (PTT) ≤ 1.5 times the institutional upper limit of normal (ULN) within 14 days prior to registration. 8. Serum creatinine ≤ 2.0 times the institutional ULN within 14 days prior to registration. 9. Serum magnesium, potassium and adjusted (or ionized) calcium ≥ the institutional lower limit of normal (LLN). (Supplementation of electrolytes prior to screening is allowed). 10. Left ventricular ejection fraction ≥ 45% measured by echocardiogram or multiple gated acquisition (MUGA) within 30 days prior to registration (but must be performed after the last dose of an anthracycline) for subjects who have received an anthracycline (e.g. doxorubicin, epirubicin) or have a medical history of cardiac disease. The measurement of left ventricular ejection fraction is not required of subjects whom have not received cardiotoxic chemotherapy (e.g. anthracycline) and do not have a medical history of cardiac disease. 11. Sexually active women and men of childbearing potential must agree to use an effective method of birth control during the course of the study and for up to 3 months following the last dose of the study drug, in a manner such that risk of pregnancy is minimized. Surgical sterilization, intrauterine device or barrier method (e.g. condom and/or diaphragm with spermicidal agents) are acceptable forms of birth control. 12. Women of childbearing potential must have a negative pregnancy test (urine or serum) within 7 days prior to treatment. A pregnancy test is not required for registration. Women who have not menstruated for more than 2 years will be considered postmenopausal, thus not of childbearing potential. 13. Eastern Cooperative Oncology Group (ECOG) performance score 0, 1 or 2. 14. Weight ≥ 50 kg because there is limited experience with dasatinib in subjects weighing less than 50 kg. 15. ≥13 years of age Minors will be required to sign an assent document prior to treatment. 16. Subjects must be able to swallow whole tablets. 17. Subjects must be informed of the investigational nature of the study and provide written, informed consent and authorization to release protected health information using a document(s) approved by the investigator's institution. 18. A paraffin block, either from a previous surgery or recent biopsy, should be available for correlative studies. If a block of tumor is not available, at least 8 unstained slides of tumor sample, 1 H&E and three (3) 15 micron-thick sections in an eppendorf tube for DNA extraction from a representative portion of the sarcoma may be substituted after discussion with and approval from the study Principal Investigator.
Exclusion criteria
1. Subjects who are curable by conventional multidisciplinary management. 2. Subjects with symptomatic central nervous system metastasis. 3. Women who are pregnant or nursing/breastfeeding. 4. History of significant bleeding disorder unrelated to cancer, including: * Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease) * Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies) 5. Subjects currently taking medications that inhibit platelet function (i.e., aspirin, dipyridamole, epoprostenol, eptifibatide, clopidogrel, cilostazol, abciximab, ticlopidine, and any non-steroidal anti-inflammatory drug) because of a potential increased risk of bleeding from dasatinib. 6. Subjects currently taking anticoagulants (warfarin, heparin/low molecular weight heparin \[e.g., danaparoid, dalteparin, tinzaparin, enoxaparin\]) because of a potential increased risk of bleeding from dasatinib. 7. Diagnosis of unstable angina or myocardial infarction within 6 months of study entry. 8. Subjects currently taking one or more of the following drugs that are generally accepted to have a risk of causing Torsades de Pointes: * Quinidine, procainamide, disopyramide * Amiodarone, sotalol, ibutilide, dofetilide * Erythromycins, clarithromycin * Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide * Cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine. 9. Diagnosed or suspected congenital long QT syndrome. 10. Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (\> 450 msec) within 30 days prior to study registration. 11. Subjects unable or unwilling to suspend treatment with bisphosphonates for at least the first 8 weeks of treatment with study drug because of the risk of hypocalcemia caused by dasatinib.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate: Number of Participants With Objective Tumor Response | Up to 24 months | Assessment of objective tumor response for response rate with MRI or CT using Choi criteria: Complete Remission (CR) Complete disappearance of all measurable and evaluable disease for at least 4 weeks; Partial Remission (PR) A 10% or greater decrease from the baseline in the sum of the largest diameters of all measurable target lesions. |
| 6 Month Progression-free Survival Rate of Indolent Sarcomas Treated With Dasatinib | At 6 months | Estimate the 6 month progression-free survival rate of indolent sarcomas treated with dasatinib. Progression is defined using Choi criteria, as a 10% or greater increase in the sum of all measurable target lesions over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, or clear worsening of any evaluable disease, or unequivocal reappearance of any lesion which had disappeared, or appearance of any new lesions of greater than double slice thickness in size, or any new or enlarging solid nodule in a previously hypodense treated mass. |
| 6 Month Progression-free Survival Rate of Gastrointestinal Stromal Tumors (GIST) | 6 months | To estimate the 6 month progression-free survival rate of gastrointestinal stromal tumors (GIST). Progression is defined using Choi criteria, as a 10% or greater increase in the sum of all measurable target lesions over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, or clear worsening of any evaluable disease, or unequivocal reappearance of any lesion which had disappeared, or appearance of any new lesions of greater than double slice thickness in size, or any new or enlarging solid nodule in a previously hypodense treated mass. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6 Month Progression-free Survival Rate of Subjects Enrolled in the Aggressive Subtype. | At 6 months | To estimate the 6 month progression-free survival rate of subjects with leiomyosarcoma, liposarcoma, osteosarcoma including high-grade chondrosarcomas, Ewing's sarcoma, Malignant fibrous histiocytoma (MFH), rhabdomyosarcoma and MPNST treated with dasatinib. |
| Median Time-to-progression of Subjects Enrolled in the Aggressive Subtype. | Up to 37 weeks | To estimate the median time-to-progression of subjects with leiomyosarcoma, liposarcoma, osteosarcoma including high-grade chondrosarcomas, Ewing's sarcoma, MFH, rhabdomyosarcoma and MPNST treated with dasatinib. |
| Overall Survival Rates at 2 and 5 Years From Registration of Subjects Enrolled in the Aggressive Subtype Treated With Dasatinib. | At 2 and 5 years | To estimate the overall survival rates at 2 and 5 years from registration of subjects enrolled in the aggressive subtype treated with dasatinib. |
| Median Time-to-progression of Subjects With GIST Treated With Dasatinib. | Up to 30 months | To estimate the median time-to-progression of subjects with GIST treated with dasatinib. |
| Plasma Level of Dasatinib and Inhibition of SRC and/or Focal Adhesion Kinase (FAK) in Peripheral Blood Mononuclear Cells | 2-4 weeks from start of treatment | Obtain blood samples to characterize plasma level of dasatinib and inhibition of SRC and/or FAK in peripheral blood mononuclear cells 2 hours after ingestion of drug at 2-4 weeks from the start of treatment if activity of the drug in a sarcoma subtype warrants further study. |
| Number of Participants With Tumors With Kinase Expression | Up to 37 weeks | Obtain tumor tissue for creation of tissue microarrays to examine the frequency of kinase expression such as SRC and/or FAK in leiomyosarcoma, liposarcoma, osteosarcoma, MFH, rhabdomyosarcoma, MPNST, chondrosarcoma, Ewing's, Alveolar soft part sarcoma (ASPS), chordoma, epithelioid sarcoma, giant cell tumor of bone, hemangiopericytoma, and GIST if activity of the drug in a subtype warrants further study. The outcome measure demonstrates the number of participants who had tissue that was able to generate tissue microarray for kinase expression. |
| Number of Participants With Tumors With Mutations in Kinases | Up to 37 weeks | Obtain tumor tissue to examine the frequency of mutations in kinases such as PDGFR in leiomyosarcoma, liposarcoma, osteosarcoma, MFH, rhabdomyosarcoma, MPNST, chondrosarcoma, Ewing's, ASPS, chordoma, epithelioid sarcoma, giant cell tumor of bone, hemangiopericytoma and GIST if activity of the drug in a subtype warrants further study. The outcome measure demonstrates the tissue that was able to generate tissue microarray for PDGFR analysis. |
| Uni-dimensional and Bi-dimensional Tumor Size, Tumor Volumes and Tumor Average Density Determined by Computer-aided Automated Detection in a Subset of Subjects With Tumor Predominately Involving the Lung | Up to 37 weeks | To prospectively collect uni-dimensional and bi-dimensional tumor size, tumor volumes and tumor average density determined by computer-aided automated detection in a subset of subjects with tumor predominately involving the lung |
| Overall Survival Rates at 2 and 5 Years From Registration of Subjects Treated With Dasatinib. | At 2 and 5 years | To estimate the overall survival rates at 2 and 5 years from registration of subjects treated with dasatinib. |
| Median Time-to-progression of Subjects With Indolent Sarcomas Treated With Dasatinib. | Up to 24 months | To estimate the median time-to-progression of subjects with indolent sarcomas treated with dasatinib. |
Countries
United States
Participant flow
Recruitment details
50 patients with GIST were enrolled between June 2008 and December 2009 and 48 were evaluable for response. Between May 2007 and May 2009, 200 patients with advanced, high-grade sarcoma were enrolled into the aggressive subtype for this study. 116 patients were registered beginning in July 2007 to the indolent subtype for this study.
Participants by arm
| Arm | Count |
|---|---|
| Dasatinib, 70 mg, Twice Daily Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Dasatinib: oral agent, continuous dosing, Cycles = 28 days | 359 |
| Total | 359 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Ineligible sarcoma subtype | 0 | 2 | 2 |
| Overall Study | Physician Decision | 1 | 0 | 0 |
| Overall Study | Use of prohibited concomitant medication | 0 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 3 |
Baseline characteristics
| Characteristic | Dasatinib, 70 mg, Twice Daily |
|---|---|
| Age, Continuous Aggressive subtype | 52 years |
| Age, Continuous GIST | 60 years |
| Age, Continuous Indolent | 54 years |
| Race/Ethnicity, Customized Aggressive subtype Asian | 6 Participants |
| Race/Ethnicity, Customized Aggressive subtype Black | 15 Participants |
| Race/Ethnicity, Customized Aggressive subtype Native American | 0 Participants |
| Race/Ethnicity, Customized Aggressive subtype Other | 6 Participants |
| Race/Ethnicity, Customized Aggressive subtype Unknown | 2 Participants |
| Race/Ethnicity, Customized Aggressive subtype White | 171 Participants |
| Race/Ethnicity, Customized GIST Asian | 3 Participants |
| Race/Ethnicity, Customized GIST Black | 3 Participants |
| Race/Ethnicity, Customized GIST Native American | 1 Participants |
| Race/Ethnicity, Customized GIST Other | 1 Participants |
| Race/Ethnicity, Customized GIST Unknown | 1 Participants |
| Race/Ethnicity, Customized GIST White | 41 Participants |
| Race/Ethnicity, Customized Indolent Asian | 3 Participants |
| Race/Ethnicity, Customized Indolent Black | 8 Participants |
| Race/Ethnicity, Customized Indolent Native American | 0 Participants |
| Race/Ethnicity, Customized Indolent Other | 4 Participants |
| Race/Ethnicity, Customized Indolent Unknown | 0 Participants |
| Race/Ethnicity, Customized Indolent White | 94 Participants |
| Sex: Female, Male Aggressive subtype Female | 96 Participants |
| Sex: Female, Male Aggressive subtype Male | 104 Participants |
| Sex: Female, Male GIST Female | 19 Participants |
| Sex: Female, Male GIST Male | 31 Participants |
| Sex: Female, Male Indolent Female | 33 Participants |
| Sex: Female, Male Indolent Male | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 314 / 355 |
| serious Total, serious adverse events | 158 / 355 |
Outcome results
Primary
6 Month Progression-free Survival Rate of Gastrointestinal Stromal Tumors (GIST)
To estimate the 6 month progression-free survival rate of gastrointestinal stromal tumors (GIST). Progression is defined using Choi criteria, as a 10% or greater increase in the sum of all measurable target lesions over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, or clear worsening of any evaluable disease, or unequivocal reappearance of any lesion which had disappeared, or appearance of any new lesions of greater than double slice thickness in size, or any new or enlarging solid nodule in a previously hypodense treated mass.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GIST: Dasatinib, 70 mg, Twice Daily | 6 Month Progression-free Survival Rate of Gastrointestinal Stromal Tumors (GIST) | 14 Participants |
Primary
6 Month Progression-free Survival Rate of Indolent Sarcomas Treated With Dasatinib
Estimate the 6 month progression-free survival rate of indolent sarcomas treated with dasatinib. Progression is defined using Choi criteria, as a 10% or greater increase in the sum of all measurable target lesions over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, or clear worsening of any evaluable disease, or unequivocal reappearance of any lesion which had disappeared, or appearance of any new lesions of greater than double slice thickness in size, or any new or enlarging solid nodule in a previously hypodense treated mass.
Time frame: At 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GIST: Dasatinib, 70 mg, Twice Daily | 6 Month Progression-free Survival Rate of Indolent Sarcomas Treated With Dasatinib | 52 Participants |
Primary
Response Rate: Number of Participants With Objective Tumor Response
Assessment of objective tumor response for response rate with MRI or CT using Choi criteria: Complete Remission (CR) Complete disappearance of all measurable and evaluable disease for at least 4 weeks; Partial Remission (PR) A 10% or greater decrease from the baseline in the sum of the largest diameters of all measurable target lesions.
Time frame: Up to 24 months
Population: 116 subjects enrolled in the Indolent subtype, however 109 subjects began treatment. 50 patients enrolled in the GIST subtype, however 48 patients were evaluable. This explains the discrepancy between Overall Number of Participants Analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GIST: Dasatinib, 70 mg, Twice Daily | Response Rate: Number of Participants With Objective Tumor Response | 12 Participants |
| Aggressive Subtypes: Dasatinib, 70 mg, Twice Daily | Response Rate: Number of Participants With Objective Tumor Response | 14 Participants |
| Indolent Subtype: Dasatinib, 70 mg, Twice Daily | Response Rate: Number of Participants With Objective Tumor Response | 20 Participants |
Secondary
6 Month Progression-free Survival Rate of Subjects Enrolled in the Aggressive Subtype.
To estimate the 6 month progression-free survival rate of subjects with leiomyosarcoma, liposarcoma, osteosarcoma including high-grade chondrosarcomas, Ewing's sarcoma, Malignant fibrous histiocytoma (MFH), rhabdomyosarcoma and MPNST treated with dasatinib.
Time frame: At 6 months
Population: The numbers analyzed in one or more rows are different because they are broken up by cohorts.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GIST: Dasatinib, 70 mg, Twice Daily | 6 Month Progression-free Survival Rate of Subjects Enrolled in the Aggressive Subtype. | UPS | 6 Participants |
| GIST: Dasatinib, 70 mg, Twice Daily | 6 Month Progression-free Survival Rate of Subjects Enrolled in the Aggressive Subtype. | Leiomyosarcoma | 5 Participants |
| GIST: Dasatinib, 70 mg, Twice Daily | 6 Month Progression-free Survival Rate of Subjects Enrolled in the Aggressive Subtype. | Osteosarcoma | 5 Participants |
| GIST: Dasatinib, 70 mg, Twice Daily | 6 Month Progression-free Survival Rate of Subjects Enrolled in the Aggressive Subtype. | Rhabdomyosarcoma | 0 Participants |
| GIST: Dasatinib, 70 mg, Twice Daily | 6 Month Progression-free Survival Rate of Subjects Enrolled in the Aggressive Subtype. | Ewing's Sarcoma | 1 Participants |
| GIST: Dasatinib, 70 mg, Twice Daily | 6 Month Progression-free Survival Rate of Subjects Enrolled in the Aggressive Subtype. | Liposarcoma | 0 Participants |
| GIST: Dasatinib, 70 mg, Twice Daily | 6 Month Progression-free Survival Rate of Subjects Enrolled in the Aggressive Subtype. | MPNST | 0 Participants |
Secondary
Median Time-to-progression of Subjects Enrolled in the Aggressive Subtype.
To estimate the median time-to-progression of subjects with leiomyosarcoma, liposarcoma, osteosarcoma including high-grade chondrosarcomas, Ewing's sarcoma, MFH, rhabdomyosarcoma and MPNST treated with dasatinib.
Time frame: Up to 37 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| GIST: Dasatinib, 70 mg, Twice Daily | Median Time-to-progression of Subjects Enrolled in the Aggressive Subtype. | 1.9 months |
Secondary
Median Time-to-progression of Subjects With GIST Treated With Dasatinib.
To estimate the median time-to-progression of subjects with GIST treated with dasatinib.
Time frame: Up to 30 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| GIST: Dasatinib, 70 mg, Twice Daily | Median Time-to-progression of Subjects With GIST Treated With Dasatinib. | 2.9 months |
Secondary
Median Time-to-progression of Subjects With Indolent Sarcomas Treated With Dasatinib.
To estimate the median time-to-progression of subjects with indolent sarcomas treated with dasatinib.
Time frame: Up to 24 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| GIST: Dasatinib, 70 mg, Twice Daily | Median Time-to-progression of Subjects With Indolent Sarcomas Treated With Dasatinib. | 5.8 months |
Secondary
Number of Participants With Tumors With Kinase Expression
Obtain tumor tissue for creation of tissue microarrays to examine the frequency of kinase expression such as SRC and/or FAK in leiomyosarcoma, liposarcoma, osteosarcoma, MFH, rhabdomyosarcoma, MPNST, chondrosarcoma, Ewing's, Alveolar soft part sarcoma (ASPS), chordoma, epithelioid sarcoma, giant cell tumor of bone, hemangiopericytoma, and GIST if activity of the drug in a subtype warrants further study. The outcome measure demonstrates the number of participants who had tissue that was able to generate tissue microarray for kinase expression.
Time frame: Up to 37 weeks
Population: The overall number of participants analyzed demonstrates the number of participants whose tumor samples received. The results illustrate the tissue that was able to generate tissue microarray for SRC and FAK analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GIST: Dasatinib, 70 mg, Twice Daily | Number of Participants With Tumors With Kinase Expression | 11 Participants |
| Aggressive Subtypes: Dasatinib, 70 mg, Twice Daily | Number of Participants With Tumors With Kinase Expression | 24 Participants |
| Indolent Subtype: Dasatinib, 70 mg, Twice Daily | Number of Participants With Tumors With Kinase Expression | 16 Participants |
Secondary
Number of Participants With Tumors With Mutations in Kinases
Obtain tumor tissue to examine the frequency of mutations in kinases such as PDGFR in leiomyosarcoma, liposarcoma, osteosarcoma, MFH, rhabdomyosarcoma, MPNST, chondrosarcoma, Ewing's, ASPS, chordoma, epithelioid sarcoma, giant cell tumor of bone, hemangiopericytoma and GIST if activity of the drug in a subtype warrants further study. The outcome measure demonstrates the tissue that was able to generate tissue microarray for PDGFR analysis.
Time frame: Up to 37 weeks
Population: The overall number of participants analyzed demonstrates the number of participants whose tumor samples were received. The results illustrate the tissue that was able to generate tissue microarray for PDGFR analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GIST: Dasatinib, 70 mg, Twice Daily | Number of Participants With Tumors With Mutations in Kinases | 11 Participants |
| Aggressive Subtypes: Dasatinib, 70 mg, Twice Daily | Number of Participants With Tumors With Mutations in Kinases | 24 Participants |
| Indolent Subtype: Dasatinib, 70 mg, Twice Daily | Number of Participants With Tumors With Mutations in Kinases | 16 Participants |
Secondary
Overall Survival Rates at 2 and 5 Years From Registration of Subjects Enrolled in the Aggressive Subtype Treated With Dasatinib.
To estimate the overall survival rates at 2 and 5 years from registration of subjects enrolled in the aggressive subtype treated with dasatinib.
Time frame: At 2 and 5 years
Population: The number analyzed in one or more rows differs from overall number because the rows are broken down into cohorts. The counts in the categories will not add up to the number analyzed, because those numbers represent number of participants that have reached overall survival at 2 and 5 years.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GIST: Dasatinib, 70 mg, Twice Daily | Overall Survival Rates at 2 and 5 Years From Registration of Subjects Enrolled in the Aggressive Subtype Treated With Dasatinib. | MPNST : 5 year overall survival rate | 0 participants |
| GIST: Dasatinib, 70 mg, Twice Daily | Overall Survival Rates at 2 and 5 Years From Registration of Subjects Enrolled in the Aggressive Subtype Treated With Dasatinib. | Ewing's Sarcoma : 2 year overall survival rate | 7 participants |
| GIST: Dasatinib, 70 mg, Twice Daily | Overall Survival Rates at 2 and 5 Years From Registration of Subjects Enrolled in the Aggressive Subtype Treated With Dasatinib. | Ewing's Sarcoma : 5 year overall survival rate | 0 participants |
| GIST: Dasatinib, 70 mg, Twice Daily | Overall Survival Rates at 2 and 5 Years From Registration of Subjects Enrolled in the Aggressive Subtype Treated With Dasatinib. | Leiomyosarcoma : 2 year overall survival rate | 21 participants |
| GIST: Dasatinib, 70 mg, Twice Daily | Overall Survival Rates at 2 and 5 Years From Registration of Subjects Enrolled in the Aggressive Subtype Treated With Dasatinib. | Leiomyosarcoma : 5 year overall survival rate | 2 participants |
| GIST: Dasatinib, 70 mg, Twice Daily | Overall Survival Rates at 2 and 5 Years From Registration of Subjects Enrolled in the Aggressive Subtype Treated With Dasatinib. | Liposarcoma : 2 year overall survival rate | 0 participants |
| GIST: Dasatinib, 70 mg, Twice Daily | Overall Survival Rates at 2 and 5 Years From Registration of Subjects Enrolled in the Aggressive Subtype Treated With Dasatinib. | Liposarcoma : 5 year overall survival rate | 0 participants |
| GIST: Dasatinib, 70 mg, Twice Daily | Overall Survival Rates at 2 and 5 Years From Registration of Subjects Enrolled in the Aggressive Subtype Treated With Dasatinib. | MPNST : 2 year overall survival rate | 0 participants |
| GIST: Dasatinib, 70 mg, Twice Daily | Overall Survival Rates at 2 and 5 Years From Registration of Subjects Enrolled in the Aggressive Subtype Treated With Dasatinib. | Osteosarcoma : 2 year overall survival rate | 15 participants |
| GIST: Dasatinib, 70 mg, Twice Daily | Overall Survival Rates at 2 and 5 Years From Registration of Subjects Enrolled in the Aggressive Subtype Treated With Dasatinib. | Osteosarcoma : 5 year overall survival rate | 0 participants |
| GIST: Dasatinib, 70 mg, Twice Daily | Overall Survival Rates at 2 and 5 Years From Registration of Subjects Enrolled in the Aggressive Subtype Treated With Dasatinib. | Rhabdomyosarcoma : 2 year overall survival rate | 8 participants |
| GIST: Dasatinib, 70 mg, Twice Daily | Overall Survival Rates at 2 and 5 Years From Registration of Subjects Enrolled in the Aggressive Subtype Treated With Dasatinib. | Rhabdomyosarcoma : 5 year overall survival rate | 7 participants |
| GIST: Dasatinib, 70 mg, Twice Daily | Overall Survival Rates at 2 and 5 Years From Registration of Subjects Enrolled in the Aggressive Subtype Treated With Dasatinib. | UPS : 2 year overall survival rate | 26 participants |
| GIST: Dasatinib, 70 mg, Twice Daily | Overall Survival Rates at 2 and 5 Years From Registration of Subjects Enrolled in the Aggressive Subtype Treated With Dasatinib. | UPS : 5 year overall survival rate | 6 participants |
Secondary
Overall Survival Rates at 2 and 5 Years From Registration of Subjects Treated With Dasatinib.
To estimate the overall survival rates at 2 and 5 years from registration of subjects treated with dasatinib.
Time frame: At 2 and 5 years
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GIST: Dasatinib, 70 mg, Twice Daily | Overall Survival Rates at 2 and 5 Years From Registration of Subjects Treated With Dasatinib. | 2 years overall survival | 21 Participants |
| GIST: Dasatinib, 70 mg, Twice Daily | Overall Survival Rates at 2 and 5 Years From Registration of Subjects Treated With Dasatinib. | 5 years overall survival | 8 Participants |
| Aggressive Subtypes: Dasatinib, 70 mg, Twice Daily | Overall Survival Rates at 2 and 5 Years From Registration of Subjects Treated With Dasatinib. | 2 years overall survival | 48 Participants |
| Aggressive Subtypes: Dasatinib, 70 mg, Twice Daily | Overall Survival Rates at 2 and 5 Years From Registration of Subjects Treated With Dasatinib. | 5 years overall survival | 14 Participants |
Secondary
Plasma Level of Dasatinib and Inhibition of SRC and/or Focal Adhesion Kinase (FAK) in Peripheral Blood Mononuclear Cells
Obtain blood samples to characterize plasma level of dasatinib and inhibition of SRC and/or FAK in peripheral blood mononuclear cells 2 hours after ingestion of drug at 2-4 weeks from the start of treatment if activity of the drug in a sarcoma subtype warrants further study.
Time frame: 2-4 weeks from start of treatment
Population: Evaluation of blood levels of drug was not performed because there was insufficient activity and the level of activity did not warrant further study.
Secondary
Uni-dimensional and Bi-dimensional Tumor Size, Tumor Volumes and Tumor Average Density Determined by Computer-aided Automated Detection in a Subset of Subjects With Tumor Predominately Involving the Lung
To prospectively collect uni-dimensional and bi-dimensional tumor size, tumor volumes and tumor average density determined by computer-aided automated detection in a subset of subjects with tumor predominately involving the lung
Time frame: Up to 37 weeks
Population: This data was not collected because the imaging software and work station was not obtained.