Breast Cancer, Metastatic Cancer
Conditions
Keywords
stage IV breast cancer, male breast cancer, recurrent breast cancer, bone metastases
Brief summary
RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This randomized phase II trial is studying two different schedules of dasatinib to compare how well they work in treating patients with stage IV breast cancer that has spread to the bone.
Detailed description
OBJECTIVES: * Compare the progression-free survival of patients with stage IV bone metastasis-predominant breast cancer treated with 1 of 2 treatment schedules of dasatinib. * Compare the response rate (complete and partial, confirmed and unconfirmed) in patients treated with these regimens. * Compare the MUC-1 antigen response rate (CA 15-3 or CA 27-29) in patients treated with these regimens. * Compare the circulating tumor cell response rate in patients treated with these regimens. * Compare the anti-osteoclast activity, as measured by changes in bone turnover markers, in patients treated with these regimens. * Compare the frequency and severity of toxicities of these regimens in these patients. * Compare the pain profiles of these patients and explore changes over time. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to concurrent trastuzumab (Herceptin®) treatment (yes vs no). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral dasatinib once daily. * Arm II: Patients receive oral dasatinib twice daily. In both treatment arms, treatment continues for at least 24 weeks in the absence of disease progression or unacceptable toxicity. Blood samples are acquired from patients once weekly in weeks 1, 4, 8, 16, and 24. Samples are analyzed for tumor markers, circulating tumor cells, and bone markers. Patients complete a self-reported brief pain inventory questionnaire at baseline and once in weeks 8, 16, and 24. After completion of study treatment, patients are followed every 3-6 months for up to 2 years. PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Interventions
given orally
Sponsors
Study design
Eligibility
Inclusion criteria
DISEASE CHARACTERISTICS: * Diagnosis of breast carcinoma meeting the following criteria: * Stage IV disease * Bone metastasis-predominant disease, defined as the presence of ≥ 1 bone metastasis with or without nonbone (visceral or soft tissue) disease where the number of bone metastases is at least the number of measurable visceral target lesions * Visceral disease that does not cause a reduction in ECOG performance status allowed * Must meet 1 of the following criteria: * Measurable disease within the past 28 days * Nonmeasurable disease with rising serum CA 15-3, CA 27-29, CEA, or CA-125 documented by 2 consecutive measurements taken ≥ 14 days apart with the most recent measurement being within the past 42 days * These measurements need not be consecutive, and the prior measurement could have been months to years prior to the current measurement if the marker is considered by the investigator to reflect disease progression * The second serum marker value must be greater than the institution's upper limit of normal and show ≥ a 20% increase over the first measurement * No symptomatic brain or CNS metastases * Prior CNS or brain metastasis allowed provided it was treated with radiotherapy ≥ 8 weeks ago * No pleural or pericardial effusion * Hormone receptor status known * Estrogen receptor- and/or progesterone receptor-positive disease must have progressed on ≥ 1 hormonal therapy in the metastatic setting PATIENT CHARACTERISTICS: * Male or female * Menopausal status not specified * Zubrod performance status 0-2 * QTc \< 450 msec by EKG * Ejection fraction ≥ 50% by MUGA or 2-dimensional echocardiogram with no significant abnormalities within the past 12 weeks for patients on trastuzumab * No active infection requiring systemic therapy * No uncontrolled concurrent condition that would preclude the ability to take oral medication, including the following: * Nausea * Vomiting * Diarrhea * Lack of physical integrity of the upper gastrointestinal tract * Malabsorption syndrome * No clinically significant cardiac disease, including the following: * Congestive heart failure * Symptomatic coronary artery disease * Cardiac arrhythmias not well controlled * Myocardial infarction within the past 12 months * No concurrent active malignancy * Prior malignancies allowed provided the patient is currently disease-free * Not pregnant or nursing * Fertile patients must use effective contraception during and for 3 months after completion of study therapy PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior RankL inhibitor therapy * No more than 1 prior cytotoxic chemotherapy for metastatic disease * At least 3 weeks since prior chemotherapy and recovered * At least 1 week since prior radiotherapy to non-CNS disease and recovered * At least 3 weeks since prior and no concurrent intravenous bisphosphates (e.g., zoledronate) * At least 7 days since prior and no concurrent antiplatelet agents, including any of the following\*: * Anticoagulants (e.g., tirofiban, eptifibatide, ticlopidine) * Aspirin or aspirin-containing combinations * Dipyridamole * Epoprostenol * Clopidogrel * Cilostazol * Abciximab NOTE: \*Nonsteroidal anti-inflammatory drugs and medically indicated platelet-inhibiting medication allowed * At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following: * HIV protease inhibitors (e.g., amprenavir, atazanavir, fosamprenavir, indinavir, nelfinavir, ritonavir) * Select antibiotics (e.g., ciprofloxacin, clarithromycin, doxycycline, enoxacin, isoniazid, telithromycin) * Azole antifungals (e.g., itraconazole, ketoconazole, miconazole, voriconazole) * Select anesthetics (e.g., ketamine, propofol) * Hypericum perforatum (St. John's wort) * Nefazodone * Nicardipine * Diclofenac * Quinidine * Imatinib mesylate * At least 7 days since prior and no concurrent medications that prolong the QTc interval, including any of the following: * Antiarrhythmic agents (e.g., quinidine, procainamide, disopyramide phosphate, amiodarone, sotalol hydrochloride, ibutilide, dofetilide) * Antipsychotic agents (e.g., chlorpromazine, mesoridazine, thioridazine, pimozide, haloperidol, droperidol) * Select antibiotics (e.g., erythromycin, clarithromycin, sparfloxacin, pentamidine) * Narcotic analgesics (e.g., levomethadyl, methadone, domperidone) * Calcium channel blockers (e.g., bepridil, lidoflazine) * Antimalarial agents (e.g., halofantrine, chloroquine) * Parasympathomimetic agents (e.g., cisapride) * Arsenic trioxide * No other concurrent antineoplastic therapy for breast cancer, including any of the following: * Radiotherapy * Chemotherapy * Immunotherapy * Biologic therapy * Hormonal therapy * Gene therapy * No concurrent grapefruit juice consumption * No concurrent short-acting antacid agents within 2 hours of dasatinib administration * Concurrent trastuzumab (Herceptin®) therapy for HER-2 positive patients allowed provided patients have been on continuous trastuzumab for ≥ 12 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | Up to 2 years | RECIST progression defined as 20% increase in the sum of longest diameters of target measurable lesions over the smallest sum observed, unequivocal progression of non-measurable disease, the appearance of any new lesion/site, death due to disease without prior documentation of progression and without symptomatic deterioration, development of one or more new bone lesions from baseline, or symptomatic deterioration related to disease progression. Time from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at last date of contact. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MUC-1 Antigen Response | at 4, 8, 16, and 24 weeks | MUC-1 Complete Response is reduction in MUC-1 such that MUC-1 \<= ULN. MUC-1 Partial Response is greater than or equal to a 50% reduction in MUC-1 from baseline, but not qualifying as a CR. MUC-1 Progression is greater than or equal to a 50% increase in MUC-1 from baseline. MUC-1 Stable Disease is MUC-1 response not qualifying as CR, PR, or Progression. |
| Circulating Tumor Cells (CTC) Response Rate | Up to 4 weeks | CTC response at 4 weeks is defined as the number of patients with initially elevated CTCs (\>= 5 cells/7.5 ml), whose CTC level drops to \< 5. |
| Change in Serum Bone Turnover Markers Over Time -- NTx | at baseline, 4, and 8 weeks | Analysis included mean values of the serum biomarker NTx at baseline, 4, and 8 weeks. |
| Change in Serum Bone Turnover Markers Over Time -- BAP | at baseline, 4, and 8 weeks | Analysis included mean values of the serum biomarker BAP at baseline, 4, and 8 weeks. |
| Change in Serum Bone Turnover Markers Over Time | at baseline, 4, and 8 weeks | Analysis included mean values of the serum biomarkers sRANKL, IL-6, DKK, VEGF at baseline, 4, and 8 weeks. |
| Response Rate (Complete and Partial, Confirmed and Unconfirmed) | Up to 2 years | Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms, normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration. Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed, unequivocal progression of non-measurable disease, appearance of any new lesion/site, death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression. |
| Change in Serum Bone Turnover Markers Over Time -- OPG | at baseline, 4, and 8 weeks | Analysis included mean values of the serum biomarker OPG at baseline, 4, and 8 weeks. |
| Change in Serum Bone Turnover Markers Over Time -- TRAP | at baseline, 4, and 8 weeks | Analysis included mean values of the serum biomarker TRAP at baseline, 4, and 8 weeks. |
| Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Up to 2 years | Only adverse events that are possibly, probably or definitely related to study drug are reported. |
| Mean Patient-reported Pain | Baseline, 8, 16, and 24 weeks | Patient's rating of worst pain experienced between prestudy and week 24. Changes of \>=2 points on the Brief Pain Inventory (BPI) are of interest. Pain is self-reported on the Brief Pain Inventory Short Form, on a 0-10 response scale, with higher scores reflecting more pain and more interference with functioning. |
| Change in Serum Bone Turnover Markers Over Time -- OC | at baseline, 4, and 8 weeks | Analysis included mean values of the serum biomarker OC at baseline, 4, and 8 weeks. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dasatinib, 100 mg, Daily Dasatinib, 100 mg PO daily until progression of disease | 41 |
| Dasatinib, 70 mg, Twice Daily Dasatinib, 70 mg PO twice daily until progression of disease | 38 |
| Total | 79 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 6 | 11 |
| Overall Study | Death | 0 | 2 |
| Overall Study | Ineligible | 2 | 4 |
| Overall Study | Not protocol specified | 3 | 4 |
| Overall Study | Progression | 32 | 21 |
Baseline characteristics
| Characteristic | Dasatinib, 100 mg, Daily | Total | Dasatinib, 70 mg, Twice Daily |
|---|---|---|---|
| Age, Continuous | 60 years | 60 years | 65 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants | 70 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 7 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Black | 1 participants | 3 participants | 2 participants |
| Race/Ethnicity, Customized Native American | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Pacific Islander | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized White | 38 participants | 73 participants | 35 participants |
| Sex: Female, Male Female | 41 Participants | 79 Participants | 38 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Use of trastuzumab at time of registration No | 40 participants | 78 participants | 38 participants |
| Use of trastuzumab at time of registration Yes | 1 participants | 1 participants | 0 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 34 / 41 | 36 / 38 |
| serious Total, serious adverse events | 6 / 41 | 12 / 38 |
Outcome results
Progression-free Survival
RECIST progression defined as 20% increase in the sum of longest diameters of target measurable lesions over the smallest sum observed, unequivocal progression of non-measurable disease, the appearance of any new lesion/site, death due to disease without prior documentation of progression and without symptomatic deterioration, development of one or more new bone lesions from baseline, or symptomatic deterioration related to disease progression. Time from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at last date of contact.
Time frame: Up to 2 years
Population: All eligible patients were included in this analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dasatinib, 100 mg, Daily | Progression-free Survival | 10.3 weeks |
| Dasatinib, 70 mg, Twice Daily | Progression-free Survival | 15.3 weeks |
Change in Serum Bone Turnover Markers Over Time
Analysis included mean values of the serum biomarkers sRANKL, IL-6, DKK, VEGF at baseline, 4, and 8 weeks.
Time frame: at baseline, 4, and 8 weeks
Population: Number of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dasatinib, 100 mg, Daily | Change in Serum Bone Turnover Markers Over Time | VEGF | 459.01 pg/mL | Standard Deviation 324.89 |
| Dasatinib, 100 mg, Daily | Change in Serum Bone Turnover Markers Over Time | sRANKL | 772172 pg/mL | Standard Deviation 1580514 |
| Dasatinib, 100 mg, Daily | Change in Serum Bone Turnover Markers Over Time | DKK | 1157.64 pg/mL | Standard Deviation 1465.83 |
| Dasatinib, 100 mg, Daily | Change in Serum Bone Turnover Markers Over Time | IL-6 | 250.17 pg/mL | Standard Deviation 1588.17 |
| Dasatinib, 70 mg, Twice Daily | Change in Serum Bone Turnover Markers Over Time | VEGF | 424.21 pg/mL | Standard Deviation 355.33 |
| Dasatinib, 70 mg, Twice Daily | Change in Serum Bone Turnover Markers Over Time | IL-6 | 19.03 pg/mL | Standard Deviation 73.7 |
| Dasatinib, 70 mg, Twice Daily | Change in Serum Bone Turnover Markers Over Time | sRANKL | 531173 pg/mL | Standard Deviation 910765 |
| Dasatinib, 70 mg, Twice Daily | Change in Serum Bone Turnover Markers Over Time | DKK | 1470.50 pg/mL | Standard Deviation 1985.09 |
| NTx at 8 Weeks | Change in Serum Bone Turnover Markers Over Time | sRANKL | 553459 pg/mL | Standard Deviation 864151 |
| NTx at 8 Weeks | Change in Serum Bone Turnover Markers Over Time | DKK | 1575.05 pg/mL | Standard Deviation 1993.44 |
| NTx at 8 Weeks | Change in Serum Bone Turnover Markers Over Time | IL-6 | 32.03 pg/mL | Standard Deviation 190.36 |
| NTx at 8 Weeks | Change in Serum Bone Turnover Markers Over Time | VEGF | 412.33 pg/mL | Standard Deviation 346.58 |
Change in Serum Bone Turnover Markers Over Time -- BAP
Analysis included mean values of the serum biomarker BAP at baseline, 4, and 8 weeks.
Time frame: at baseline, 4, and 8 weeks
Population: Number of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dasatinib, 100 mg, Daily | Change in Serum Bone Turnover Markers Over Time -- BAP | 24.07 ug/L | Standard Deviation 15.95 |
| Dasatinib, 70 mg, Twice Daily | Change in Serum Bone Turnover Markers Over Time -- BAP | 24.35 ug/L | Standard Deviation 13.94 |
| NTx at 8 Weeks | Change in Serum Bone Turnover Markers Over Time -- BAP | 25.61 ug/L | Standard Deviation 14.05 |
Change in Serum Bone Turnover Markers Over Time -- NTx
Analysis included mean values of the serum biomarker NTx at baseline, 4, and 8 weeks.
Time frame: at baseline, 4, and 8 weeks
Population: Number of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dasatinib, 100 mg, Daily | Change in Serum Bone Turnover Markers Over Time -- NTx | 21.84 nM BCE | Standard Deviation 12.32 |
| Dasatinib, 70 mg, Twice Daily | Change in Serum Bone Turnover Markers Over Time -- NTx | 19.23 nM BCE | Standard Deviation 11.32 |
| NTx at 8 Weeks | Change in Serum Bone Turnover Markers Over Time -- NTx | 12.88 nM BCE | Standard Deviation 13.09 |
Change in Serum Bone Turnover Markers Over Time -- OC
Analysis included mean values of the serum biomarker OC at baseline, 4, and 8 weeks.
Time frame: at baseline, 4, and 8 weeks
Population: Number of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dasatinib, 100 mg, Daily | Change in Serum Bone Turnover Markers Over Time -- OC | 11.08 ng/mL | Standard Deviation 7.76 |
| Dasatinib, 70 mg, Twice Daily | Change in Serum Bone Turnover Markers Over Time -- OC | 13.10 ng/mL | Standard Deviation 9.17 |
| NTx at 8 Weeks | Change in Serum Bone Turnover Markers Over Time -- OC | 13.54 ng/mL | Standard Deviation 10.2 |
Change in Serum Bone Turnover Markers Over Time -- OPG
Analysis included mean values of the serum biomarker OPG at baseline, 4, and 8 weeks.
Time frame: at baseline, 4, and 8 weeks
Population: Number of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dasatinib, 100 mg, Daily | Change in Serum Bone Turnover Markers Over Time -- OPG | 4.56 pmol/L | Standard Deviation 5.44 |
| Dasatinib, 70 mg, Twice Daily | Change in Serum Bone Turnover Markers Over Time -- OPG | 6.53 pmol/L | Standard Deviation 9.46 |
| NTx at 8 Weeks | Change in Serum Bone Turnover Markers Over Time -- OPG | 6.71 pmol/L | Standard Deviation 10.09 |
Change in Serum Bone Turnover Markers Over Time -- TRAP
Analysis included mean values of the serum biomarker TRAP at baseline, 4, and 8 weeks.
Time frame: at baseline, 4, and 8 weeks
Population: Number of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dasatinib, 100 mg, Daily | Change in Serum Bone Turnover Markers Over Time -- TRAP | 6.83 U/L | Standard Deviation 6.42 |
| Dasatinib, 70 mg, Twice Daily | Change in Serum Bone Turnover Markers Over Time -- TRAP | 5.41 U/L | Standard Deviation 4.23 |
| NTx at 8 Weeks | Change in Serum Bone Turnover Markers Over Time -- TRAP | 5.59 U/L | Standard Deviation 4.4 |
Circulating Tumor Cells (CTC) Response Rate
CTC response at 4 weeks is defined as the number of patients with initially elevated CTCs (\>= 5 cells/7.5 ml), whose CTC level drops to \< 5.
Time frame: Up to 4 weeks
Population: Treatment arms are combined in this analysis. Only eligible patients evaluated at both baseline and at 4 weeks were included. Patients analyzed for CTC response only includes patients who had elevated CTCs at baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dasatinib, 100 mg, Daily | Circulating Tumor Cells (CTC) Response Rate | 4 participants |
Mean Patient-reported Pain
Patient's rating of worst pain experienced between prestudy and week 24. Changes of \>=2 points on the Brief Pain Inventory (BPI) are of interest. Pain is self-reported on the Brief Pain Inventory Short Form, on a 0-10 response scale, with higher scores reflecting more pain and more interference with functioning.
Time frame: Baseline, 8, 16, and 24 weeks
Population: All patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dasatinib, 100 mg, Daily | Mean Patient-reported Pain | 3.37 units on a scale | Standard Deviation 2.93 |
| Dasatinib, 70 mg, Twice Daily | Mean Patient-reported Pain | 3.82 units on a scale | Standard Deviation 3.04 |
| NTx at 8 Weeks | Mean Patient-reported Pain | 3.06 units on a scale | Standard Deviation 2.61 |
| Dasatinib - Week 24 | Mean Patient-reported Pain | 3.73 units on a scale | Standard Deviation 3.03 |
MUC-1 Antigen Response
MUC-1 Complete Response is reduction in MUC-1 such that MUC-1 \<= ULN. MUC-1 Partial Response is greater than or equal to a 50% reduction in MUC-1 from baseline, but not qualifying as a CR. MUC-1 Progression is greater than or equal to a 50% increase in MUC-1 from baseline. MUC-1 Stable Disease is MUC-1 response not qualifying as CR, PR, or Progression.
Time frame: at 4, 8, 16, and 24 weeks
Population: MUC-1 Inadequate Assessment, response unknown: MUC-1 response has not been adequately assessed at indicated timepoints.
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time frame: Up to 2 years
Population: Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE v3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dasatinib, 100 mg, Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Neutrophils/granulocytes (ANC/AGC) | 0 Participants |
| Dasatinib, 100 mg, Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | AST, SGOT | 1 Participants |
| Dasatinib, 100 mg, Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Bone | 1 Participants |
| Dasatinib, 100 mg, Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Fatigue (asthenia, lethargy, malaise) | 0 Participants |
| Dasatinib, 100 mg, Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Buttock | 1 Participants |
| Dasatinib, 100 mg, Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Albumin, serum-low (hypoalbuminemia) | 0 Participants |
| Dasatinib, 100 mg, Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Chest wall | 1 Participants |
| Dasatinib, 100 mg, Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Skin | 0 Participants |
| Dasatinib, 100 mg, Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Chest/thorax NOS | 1 Participants |
| Dasatinib, 100 mg, Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Anorexia | 0 Participants |
| Dasatinib, 100 mg, Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Head/headache | 1 Participants |
| Dasatinib, 100 mg, Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - UTI | 1 Participants |
| Dasatinib, 100 mg, Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Platelets | 2 Participants |
| Dasatinib, 100 mg, Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | ALT, SGPT (serum glutamic pyruvic transaminase) | 1 Participants |
| Dasatinib, 100 mg, Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pleural effusion (non-malignant) | 1 Participants |
| Dasatinib, 100 mg, Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Infection with unknown ANC - Dental-tooth | 1 Participants |
| Dasatinib, 100 mg, Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pneumonitis/pulmonary infiltrates | 1 Participants |
| Dasatinib, 100 mg, Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Dehydration | 0 Participants |
| Dasatinib, 100 mg, Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Potassium, serum-low (hypokalemia) | 1 Participants |
| Dasatinib, 100 mg, Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Left ventricular systolic dysfunction | 2 Participants |
| Dasatinib, 100 mg, Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pulmonary hypertension | 0 Participants |
| Dasatinib, 100 mg, Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Diarrhea | 0 Participants |
| Dasatinib, 100 mg, Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pulmonary/Upper Respiratory-Other (Specify) | 0 Participants |
| Dasatinib, 100 mg, Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Lymphopenia | 0 Participants |
| Dasatinib, 100 mg, Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Rash/desquamation | 0 Participants |
| Dasatinib, 100 mg, Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemoglobin | 0 Participants |
| Dasatinib, 100 mg, Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Sodium, serum-low (hyponatremia) | 0 Participants |
| Dasatinib, 100 mg, Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Nausea | 0 Participants |
| Dasatinib, 100 mg, Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Vomiting | 0 Participants |
| Dasatinib, 100 mg, Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Dyspnea (shortness of breath) | 1 Participants |
| Dasatinib, 70 mg, Twice Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Vomiting | 1 Participants |
| Dasatinib, 70 mg, Twice Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Dehydration | 1 Participants |
| Dasatinib, 70 mg, Twice Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemoglobin | 1 Participants |
| Dasatinib, 70 mg, Twice Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | ALT, SGPT (serum glutamic pyruvic transaminase) | 2 Participants |
| Dasatinib, 70 mg, Twice Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Albumin, serum-low (hypoalbuminemia) | 1 Participants |
| Dasatinib, 70 mg, Twice Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Anorexia | 1 Participants |
| Dasatinib, 70 mg, Twice Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Diarrhea | 2 Participants |
| Dasatinib, 70 mg, Twice Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Dyspnea (shortness of breath) | 4 Participants |
| Dasatinib, 70 mg, Twice Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Fatigue (asthenia, lethargy, malaise) | 6 Participants |
| Dasatinib, 70 mg, Twice Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Skin | 1 Participants |
| Dasatinib, 70 mg, Twice Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - UTI | 1 Participants |
| Dasatinib, 70 mg, Twice Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Infection with unknown ANC - Dental-tooth | 0 Participants |
| Dasatinib, 70 mg, Twice Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Left ventricular systolic dysfunction | 1 Participants |
| Dasatinib, 70 mg, Twice Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Lymphopenia | 1 Participants |
| Dasatinib, 70 mg, Twice Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Nausea | 1 Participants |
| Dasatinib, 70 mg, Twice Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Neutrophils/granulocytes (ANC/AGC) | 1 Participants |
| Dasatinib, 70 mg, Twice Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Bone | 1 Participants |
| Dasatinib, 70 mg, Twice Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Buttock | 0 Participants |
| Dasatinib, 70 mg, Twice Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Chest wall | 0 Participants |
| Dasatinib, 70 mg, Twice Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Chest/thorax NOS | 0 Participants |
| Dasatinib, 70 mg, Twice Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Head/headache | 1 Participants |
| Dasatinib, 70 mg, Twice Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Platelets | 1 Participants |
| Dasatinib, 70 mg, Twice Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pleural effusion (non-malignant) | 2 Participants |
| Dasatinib, 70 mg, Twice Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pneumonitis/pulmonary infiltrates | 0 Participants |
| Dasatinib, 70 mg, Twice Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Potassium, serum-low (hypokalemia) | 3 Participants |
| Dasatinib, 70 mg, Twice Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pulmonary hypertension | 1 Participants |
| Dasatinib, 70 mg, Twice Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pulmonary/Upper Respiratory-Other (Specify) | 1 Participants |
| Dasatinib, 70 mg, Twice Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Rash/desquamation | 1 Participants |
| Dasatinib, 70 mg, Twice Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Sodium, serum-low (hyponatremia) | 1 Participants |
| Dasatinib, 70 mg, Twice Daily | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | AST, SGOT | 1 Participants |
Response Rate (Complete and Partial, Confirmed and Unconfirmed)
Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms, normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration. Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed, unequivocal progression of non-measurable disease, appearance of any new lesion/site, death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.
Time frame: Up to 2 years
Population: All eligible patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dasatinib, 100 mg, Daily | Response Rate (Complete and Partial, Confirmed and Unconfirmed) | Partial Response | 1 participants |
| Dasatinib, 100 mg, Daily | Response Rate (Complete and Partial, Confirmed and Unconfirmed) | Stable/No Response | 14 participants |
| Dasatinib, 100 mg, Daily | Response Rate (Complete and Partial, Confirmed and Unconfirmed) | Assessment Inadequate | 6 participants |
| Dasatinib, 100 mg, Daily | Response Rate (Complete and Partial, Confirmed and Unconfirmed) | Increasing Disease | 20 participants |
| Dasatinib, 70 mg, Twice Daily | Response Rate (Complete and Partial, Confirmed and Unconfirmed) | Assessment Inadequate | 10 participants |
| Dasatinib, 70 mg, Twice Daily | Response Rate (Complete and Partial, Confirmed and Unconfirmed) | Partial Response | 0 participants |
| Dasatinib, 70 mg, Twice Daily | Response Rate (Complete and Partial, Confirmed and Unconfirmed) | Stable/No Response | 18 participants |
| Dasatinib, 70 mg, Twice Daily | Response Rate (Complete and Partial, Confirmed and Unconfirmed) | Increasing Disease | 10 participants |