Skip to content

S0622, Dasatinib in Treating Patients With Stage IV Breast Cancer That Has Spread to the Bone

Phase II Studies of Two Different Schedules of Dasatinib (NSC-732517) in Bone Metastasis Predominant Metastatic Breast Cancer

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00410813
Enrollment
85
Registered
2006-12-13
Start date
2007-03-31
Completion date
2014-01-31
Last updated
2017-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Metastatic Cancer

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

DRUGdasatinib

given orally

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
SWOG Cancer Research Network
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Progression-free SurvivalUp to 2 yearsRECIST 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

MeasureTime frameDescription
MUC-1 Antigen Responseat 4, 8, 16, and 24 weeksMUC-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 RateUp to 4 weeksCTC 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 -- NTxat baseline, 4, and 8 weeksAnalysis included mean values of the serum biomarker NTx at baseline, 4, and 8 weeks.
Change in Serum Bone Turnover Markers Over Time -- BAPat baseline, 4, and 8 weeksAnalysis included mean values of the serum biomarker BAP at baseline, 4, and 8 weeks.
Change in Serum Bone Turnover Markers Over Timeat baseline, 4, and 8 weeksAnalysis 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 yearsComplete 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 -- OPGat baseline, 4, and 8 weeksAnalysis included mean values of the serum biomarker OPG at baseline, 4, and 8 weeks.
Change in Serum Bone Turnover Markers Over Time -- TRAPat baseline, 4, and 8 weeksAnalysis 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 DrugUp to 2 yearsOnly adverse events that are possibly, probably or definitely related to study drug are reported.
Mean Patient-reported PainBaseline, 8, 16, and 24 weeksPatient'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 -- OCat baseline, 4, and 8 weeksAnalysis included mean values of the serum biomarker OC at baseline, 4, and 8 weeks.

Countries

United States

Participant flow

Participants by arm

ArmCount
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
Total79

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event611
Overall StudyDeath02
Overall StudyIneligible24
Overall StudyNot protocol specified34
Overall StudyProgression3221

Baseline characteristics

CharacteristicDasatinib, 100 mg, DailyTotalDasatinib, 70 mg, Twice Daily
Age, Continuous60 years60 years65 years
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants2 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
36 Participants70 Participants34 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
5 Participants7 Participants2 Participants
Race/Ethnicity, Customized
Asian
0 participants1 participants1 participants
Race/Ethnicity, Customized
Black
1 participants3 participants2 participants
Race/Ethnicity, Customized
Native American
1 participants1 participants0 participants
Race/Ethnicity, Customized
Pacific Islander
1 participants1 participants0 participants
Race/Ethnicity, Customized
White
38 participants73 participants35 participants
Sex: Female, Male
Female
41 Participants79 Participants38 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants
Use of trastuzumab at time of registration
No
40 participants78 participants38 participants
Use of trastuzumab at time of registration
Yes
1 participants1 participants0 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
34 / 4136 / 38
serious
Total, serious adverse events
6 / 4112 / 38

Outcome results

Primary

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.

ArmMeasureValue (MEDIAN)
Dasatinib, 100 mg, DailyProgression-free Survival10.3 weeks
Dasatinib, 70 mg, Twice DailyProgression-free Survival15.3 weeks
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Dasatinib, 100 mg, DailyChange in Serum Bone Turnover Markers Over TimeVEGF459.01 pg/mLStandard Deviation 324.89
Dasatinib, 100 mg, DailyChange in Serum Bone Turnover Markers Over TimesRANKL772172 pg/mLStandard Deviation 1580514
Dasatinib, 100 mg, DailyChange in Serum Bone Turnover Markers Over TimeDKK1157.64 pg/mLStandard Deviation 1465.83
Dasatinib, 100 mg, DailyChange in Serum Bone Turnover Markers Over TimeIL-6250.17 pg/mLStandard Deviation 1588.17
Dasatinib, 70 mg, Twice DailyChange in Serum Bone Turnover Markers Over TimeVEGF424.21 pg/mLStandard Deviation 355.33
Dasatinib, 70 mg, Twice DailyChange in Serum Bone Turnover Markers Over TimeIL-619.03 pg/mLStandard Deviation 73.7
Dasatinib, 70 mg, Twice DailyChange in Serum Bone Turnover Markers Over TimesRANKL531173 pg/mLStandard Deviation 910765
Dasatinib, 70 mg, Twice DailyChange in Serum Bone Turnover Markers Over TimeDKK1470.50 pg/mLStandard Deviation 1985.09
NTx at 8 WeeksChange in Serum Bone Turnover Markers Over TimesRANKL553459 pg/mLStandard Deviation 864151
NTx at 8 WeeksChange in Serum Bone Turnover Markers Over TimeDKK1575.05 pg/mLStandard Deviation 1993.44
NTx at 8 WeeksChange in Serum Bone Turnover Markers Over TimeIL-632.03 pg/mLStandard Deviation 190.36
NTx at 8 WeeksChange in Serum Bone Turnover Markers Over TimeVEGF412.33 pg/mLStandard Deviation 346.58
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
Dasatinib, 100 mg, DailyChange in Serum Bone Turnover Markers Over Time -- BAP24.07 ug/LStandard Deviation 15.95
Dasatinib, 70 mg, Twice DailyChange in Serum Bone Turnover Markers Over Time -- BAP24.35 ug/LStandard Deviation 13.94
NTx at 8 WeeksChange in Serum Bone Turnover Markers Over Time -- BAP25.61 ug/LStandard Deviation 14.05
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
Dasatinib, 100 mg, DailyChange in Serum Bone Turnover Markers Over Time -- NTx21.84 nM BCEStandard Deviation 12.32
Dasatinib, 70 mg, Twice DailyChange in Serum Bone Turnover Markers Over Time -- NTx19.23 nM BCEStandard Deviation 11.32
NTx at 8 WeeksChange in Serum Bone Turnover Markers Over Time -- NTx12.88 nM BCEStandard Deviation 13.09
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
Dasatinib, 100 mg, DailyChange in Serum Bone Turnover Markers Over Time -- OC11.08 ng/mLStandard Deviation 7.76
Dasatinib, 70 mg, Twice DailyChange in Serum Bone Turnover Markers Over Time -- OC13.10 ng/mLStandard Deviation 9.17
NTx at 8 WeeksChange in Serum Bone Turnover Markers Over Time -- OC13.54 ng/mLStandard Deviation 10.2
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
Dasatinib, 100 mg, DailyChange in Serum Bone Turnover Markers Over Time -- OPG4.56 pmol/LStandard Deviation 5.44
Dasatinib, 70 mg, Twice DailyChange in Serum Bone Turnover Markers Over Time -- OPG6.53 pmol/LStandard Deviation 9.46
NTx at 8 WeeksChange in Serum Bone Turnover Markers Over Time -- OPG6.71 pmol/LStandard Deviation 10.09
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
Dasatinib, 100 mg, DailyChange in Serum Bone Turnover Markers Over Time -- TRAP6.83 U/LStandard Deviation 6.42
Dasatinib, 70 mg, Twice DailyChange in Serum Bone Turnover Markers Over Time -- TRAP5.41 U/LStandard Deviation 4.23
NTx at 8 WeeksChange in Serum Bone Turnover Markers Over Time -- TRAP5.59 U/LStandard Deviation 4.4
Secondary

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.

ArmMeasureValue (NUMBER)
Dasatinib, 100 mg, DailyCirculating Tumor Cells (CTC) Response Rate4 participants
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Dasatinib, 100 mg, DailyMean Patient-reported Pain3.37 units on a scaleStandard Deviation 2.93
Dasatinib, 70 mg, Twice DailyMean Patient-reported Pain3.82 units on a scaleStandard Deviation 3.04
NTx at 8 WeeksMean Patient-reported Pain3.06 units on a scaleStandard Deviation 2.61
Dasatinib - Week 24Mean Patient-reported Pain3.73 units on a scaleStandard Deviation 3.03
Secondary

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.

Secondary

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.

ArmMeasureGroupValue (NUMBER)
Dasatinib, 100 mg, DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugNeutrophils/granulocytes (ANC/AGC)0 Participants
Dasatinib, 100 mg, DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugAST, SGOT1 Participants
Dasatinib, 100 mg, DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPain - Bone1 Participants
Dasatinib, 100 mg, DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugFatigue (asthenia, lethargy, malaise)0 Participants
Dasatinib, 100 mg, DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPain - Buttock1 Participants
Dasatinib, 100 mg, DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugAlbumin, serum-low (hypoalbuminemia)0 Participants
Dasatinib, 100 mg, DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPain - Chest wall1 Participants
Dasatinib, 100 mg, DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf w/normal ANC or Gr 1-2 neutrophils - Skin0 Participants
Dasatinib, 100 mg, DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPain - Chest/thorax NOS1 Participants
Dasatinib, 100 mg, DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugAnorexia0 Participants
Dasatinib, 100 mg, DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPain - Head/headache1 Participants
Dasatinib, 100 mg, DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf w/normal ANC or Gr 1-2 neutrophils - UTI1 Participants
Dasatinib, 100 mg, DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPlatelets2 Participants
Dasatinib, 100 mg, DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugALT, SGPT (serum glutamic pyruvic transaminase)1 Participants
Dasatinib, 100 mg, DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPleural effusion (non-malignant)1 Participants
Dasatinib, 100 mg, DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInfection with unknown ANC - Dental-tooth1 Participants
Dasatinib, 100 mg, DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPneumonitis/pulmonary infiltrates1 Participants
Dasatinib, 100 mg, DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugDehydration0 Participants
Dasatinib, 100 mg, DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPotassium, serum-low (hypokalemia)1 Participants
Dasatinib, 100 mg, DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugLeft ventricular systolic dysfunction2 Participants
Dasatinib, 100 mg, DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPulmonary hypertension0 Participants
Dasatinib, 100 mg, DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugDiarrhea0 Participants
Dasatinib, 100 mg, DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPulmonary/Upper Respiratory-Other (Specify)0 Participants
Dasatinib, 100 mg, DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugLymphopenia0 Participants
Dasatinib, 100 mg, DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugRash/desquamation0 Participants
Dasatinib, 100 mg, DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugHemoglobin0 Participants
Dasatinib, 100 mg, DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugSodium, serum-low (hyponatremia)0 Participants
Dasatinib, 100 mg, DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugNausea0 Participants
Dasatinib, 100 mg, DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugVomiting0 Participants
Dasatinib, 100 mg, DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugDyspnea (shortness of breath)1 Participants
Dasatinib, 70 mg, Twice DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugVomiting1 Participants
Dasatinib, 70 mg, Twice DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugDehydration1 Participants
Dasatinib, 70 mg, Twice DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugHemoglobin1 Participants
Dasatinib, 70 mg, Twice DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugALT, SGPT (serum glutamic pyruvic transaminase)2 Participants
Dasatinib, 70 mg, Twice DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugAlbumin, serum-low (hypoalbuminemia)1 Participants
Dasatinib, 70 mg, Twice DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugAnorexia1 Participants
Dasatinib, 70 mg, Twice DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugDiarrhea2 Participants
Dasatinib, 70 mg, Twice DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugDyspnea (shortness of breath)4 Participants
Dasatinib, 70 mg, Twice DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugFatigue (asthenia, lethargy, malaise)6 Participants
Dasatinib, 70 mg, Twice DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf w/normal ANC or Gr 1-2 neutrophils - Skin1 Participants
Dasatinib, 70 mg, Twice DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInf w/normal ANC or Gr 1-2 neutrophils - UTI1 Participants
Dasatinib, 70 mg, Twice DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugInfection with unknown ANC - Dental-tooth0 Participants
Dasatinib, 70 mg, Twice DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugLeft ventricular systolic dysfunction1 Participants
Dasatinib, 70 mg, Twice DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugLymphopenia1 Participants
Dasatinib, 70 mg, Twice DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugNausea1 Participants
Dasatinib, 70 mg, Twice DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugNeutrophils/granulocytes (ANC/AGC)1 Participants
Dasatinib, 70 mg, Twice DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPain - Bone1 Participants
Dasatinib, 70 mg, Twice DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPain - Buttock0 Participants
Dasatinib, 70 mg, Twice DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPain - Chest wall0 Participants
Dasatinib, 70 mg, Twice DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPain - Chest/thorax NOS0 Participants
Dasatinib, 70 mg, Twice DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPain - Head/headache1 Participants
Dasatinib, 70 mg, Twice DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPlatelets1 Participants
Dasatinib, 70 mg, Twice DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPleural effusion (non-malignant)2 Participants
Dasatinib, 70 mg, Twice DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPneumonitis/pulmonary infiltrates0 Participants
Dasatinib, 70 mg, Twice DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPotassium, serum-low (hypokalemia)3 Participants
Dasatinib, 70 mg, Twice DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPulmonary hypertension1 Participants
Dasatinib, 70 mg, Twice DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugPulmonary/Upper Respiratory-Other (Specify)1 Participants
Dasatinib, 70 mg, Twice DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugRash/desquamation1 Participants
Dasatinib, 70 mg, Twice DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugSodium, serum-low (hyponatremia)1 Participants
Dasatinib, 70 mg, Twice DailyNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugAST, SGOT1 Participants
Secondary

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

ArmMeasureGroupValue (NUMBER)
Dasatinib, 100 mg, DailyResponse Rate (Complete and Partial, Confirmed and Unconfirmed)Partial Response1 participants
Dasatinib, 100 mg, DailyResponse Rate (Complete and Partial, Confirmed and Unconfirmed)Stable/No Response14 participants
Dasatinib, 100 mg, DailyResponse Rate (Complete and Partial, Confirmed and Unconfirmed)Assessment Inadequate6 participants
Dasatinib, 100 mg, DailyResponse Rate (Complete and Partial, Confirmed and Unconfirmed)Increasing Disease20 participants
Dasatinib, 70 mg, Twice DailyResponse Rate (Complete and Partial, Confirmed and Unconfirmed)Assessment Inadequate10 participants
Dasatinib, 70 mg, Twice DailyResponse Rate (Complete and Partial, Confirmed and Unconfirmed)Partial Response0 participants
Dasatinib, 70 mg, Twice DailyResponse Rate (Complete and Partial, Confirmed and Unconfirmed)Stable/No Response18 participants
Dasatinib, 70 mg, Twice DailyResponse Rate (Complete and Partial, Confirmed and Unconfirmed)Increasing Disease10 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026