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CompletedNCT00464620Updated Nov 23, 2018Results posted

Trial of Dasatinib in Advanced Sarcomas

A Phase 2 interventional study of Dasatinib in Rhabdomyosarcoma, Malignant Peripheral Nerve Sheath Tumors and Chondrosarcoma, sponsored by Sarcoma Alliance for Research through Collaboration. Completed at 20 sites in United States. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2018-11-23.

Sponsored by Sarcoma Alliance for Research through Collaboration · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
366
Allocation
Not applicable
Ages
13 Years and older
Sex
All
01

Study summary

This study will examine the response rate and the 6-month progression-free survival rates of subjects with advanced sarcoma treated with dasatinib.

Read the 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.

02

Conditions studied

  • Rhabdomyosarcoma
  • Malignant Peripheral Nerve Sheath Tumors
  • Chondrosarcoma
  • Sarcoma, Ewing's
  • Sarcoma, Alveolar Soft Part
  • Chordoma
  • Epithelioid Sarcoma
  • Giant Cell Tumor of Bone
  • Hemangiopericytoma
  • Gastrointestinal Stromal Tumor (GIST)

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)
03

In context

Rhabdomyosarcoma

238 studies on the registry are indexed under Rhabdomyosarcoma; 49 are open to participants now.

This study's enrollment of 366 is above the median of 42 across 202 interventional studies indexed under Rhabdomyosarcoma.

Browse Rhabdomyosarcoma studies →

Lead sponsor

Sarcoma Alliance for Research through Collaboration is the lead sponsor of 23 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Unresectable, recurrent, or -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./adjuvant chemotherapy qualifies as prior therapy.
  3. Subjects must have unidimensionally (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. (PT) (or INR) and Partial Thromboplastin Time (PTT) ≤ 1.5 times the institutional (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. ≥ 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 must agree to use an effective method of 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 , thus not of childbearing potential.
  13. (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 nature of the study and provide written, 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 , 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

Exclusion Criteria:

  1. Subjects who are curable by conventional multidisciplinary management.
  2. Subjects with symptomatic central nervous system .
  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 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 syndrome.
  10. Prolonged corrected QT (QTc) interval on pre-entry (> 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.
Terms in these criteria, in plain language(17)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
366 participants (actual)

Study arms

  • Experimental
    Dasatinib, 70 mg, twice daily

    Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles

    Drug: Dasatinib

Interventions

  • DrugDasatinib

    oral agent, continuous dosing, Cycles = 28 days

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

07

Results

Posted Nov 23, 2018

Participant flow

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.

Participant flow — Overall Study
MilestoneGIST: Dasatinib, 70 mg, Twice DailyAggressive Subtypes: Dasatinib, 70 mg, Twice DailyIndolent Subtype: Dasatinib, 70 mg, Twice Daily
Started50200116
Completed48198109
Not completed227
Withdrew: Physician decision100
Withdrew: Withdrawal by subject103
Withdrew: Ineligible sarcoma subtype022
Withdrew: Use of prohibited concomitant medication002

Outcome measures

PrimaryResponse 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
Reported as:
Count of participants · Participants
Response Rate: Number of Participants With Objective Tumor Response
ParticipantsGIST: Dasatinib, 70 mg, Twice DailyAggressive Subtypes: Dasatinib, 70 mg, Twice DailyIndolent Subtype: Dasatinib, 70 mg, Twice Daily
Response Rate: Number of Participants With Objective Tumor Response121420
Primary6 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
Reported as:
Count of participants · Participants
6 Month Progression-free Survival Rate of "Indolent" Sarcomas Treated With Dasatinib
ParticipantsIndolent Subtypes: Dasatinib, 70 mg, Twice Daily
6 Month Progression-free Survival Rate of "Indolent" Sarcomas Treated With Dasatinib52
Primary6 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
Reported as:
Count of participants · Participants
6 Month Progression-free Survival Rate of Gastrointestinal Stromal Tumors (GIST)
ParticipantsGIST: Dasatinib, 70 mg, Twice Daily
6 Month Progression-free Survival Rate of Gastrointestinal Stromal Tumors (GIST)14
SecondaryMedian 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
Reported as:
Median · months
Median Time-to-progression of Subjects With GIST Treated With Dasatinib.
monthsGIST: Dasatinib, 70 mg, Twice Daily
Median Time-to-progression of Subjects With GIST Treated With Dasatinib.2.9 (2 to 5.5)
SecondaryOverall 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
Reported as:
Count of participants · Participants
Overall Survival Rates at 2 and 5 Years From Registration of Subjects Treated With Dasatinib.
ParticipantsGIST: Dasatinib, 70 mg, Twice DailyIndolent Subtype: Dasatinib, 70 mg, Twice Daily
2 years overall survival2148
5 years overall survival814
SecondaryMedian 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
Reported as:
Median · months
Median Time-to-progression of Subjects With "Indolent" Sarcomas Treated With Dasatinib.
monthsIndolent Subtype: Dasatinib, 70 mg, Twice Daily
Median Time-to-progression of Subjects With "Indolent" Sarcomas Treated With Dasatinib.5.8 (3.7 to 7.4)
Secondary6 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
Reported as:
Count of participants · Participants
6 Month Progression-free Survival Rate of Subjects Enrolled in the Aggressive Subtype.
ParticipantsAggressive Subtypes: Dasatinib, 70 mg, Twice Daily
UPS6
Leiomyosarcoma5
Osteosarcoma5
Rhabdomyosarcoma0
Ewing's Sarcoma1
Liposarcoma0
MPNST0
SecondaryMedian 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
Reported as:
Median · months
Median Time-to-progression of Subjects Enrolled in the Aggressive Subtype.
monthsAggressive Subtypes: Dasatinib, 70 mg, Twice Daily
Median Time-to-progression of Subjects Enrolled in the Aggressive Subtype.1.9 (0.9 to 2.2)
SecondaryOverall 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
Reported as:
Number · participants
Overall Survival Rates at 2 and 5 Years From Registration of Subjects Enrolled in the Aggressive Subtype Treated With Dasatinib.
participantsAggressive Subtypes: Dasatinib, 70 mg, Twice Daily
Ewing's Sarcoma : 2 year overall survival rate7
Ewing's Sarcoma : 5 year overall survival rate0
Leiomyosarcoma : 2 year overall survival rate21
Leiomyosarcoma : 5 year overall survival rate2
Liposarcoma : 2 year overall survival rate0
Liposarcoma : 5 year overall survival rate0
MPNST : 2 year overall survival rate0
MPNST : 5 year overall survival rate0
Osteosarcoma : 2 year overall survival rate15
Osteosarcoma : 5 year overall survival rate0
Rhabdomyosarcoma : 2 year overall survival rate8
Rhabdomyosarcoma : 5 year overall survival rate7
UPS : 2 year overall survival rate26
UPS : 5 year overall survival rate6
SecondaryUni-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

No measurements were reported for this outcome.

SecondaryPlasma 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

No measurements were reported for this outcome.

SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Tumors With Kinase Expression
ParticipantsOsteosarcomaLeiomyosarcomaMFH/Undifferentiated Pleomorphic Sarcoma
Number of Participants With Tumors With Kinase Expression112416
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Tumors With Mutations in Kinases
ParticipantsOsteosarcomaLeiomyosarcomaMFH/Undifferentiated Pleomorphic Sarcoma
Number of Participants With Tumors With Mutations in Kinases112416

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
GIST, Aggressive, Indolent Subtypes—158/355 (44.5%)314/355 (88.5%)
Most frequent serious events
Showing 10 of 105
Most frequent serious events
EventGIST, Aggressive, Indolent Subtypes
DyspneaRespiratory, thoracic and mediastinal disorders34/355
Pleural effusionRespiratory, thoracic and mediastinal disorders30/355
NauseaGastrointestinal disorders18/355
Musculo. PainMusculoskeletal and connective tissue disorders17/355
VomitingGastrointestinal disorders17/355
FeverGeneral disorders15/355
HemoglobinInvestigations14/355
GI Pain: abdomenGastrointestinal disorders12/355
DehydrationMetabolism and nutrition disorders11/355
DiarrheaGastrointestinal disorders8/355
Most frequent other events
Showing 10 of 131
Most frequent other events
EventGIST, Aggressive, Indolent Subtypes
FatigueGeneral disorders113/355
NauseaGastrointestinal disorders81/355
DiarrheaGastrointestinal disorders73/355
AnemiaBlood and lymphatic system disorders70/355
Musculoskeletal painMusculoskeletal and connective tissue disorders67/355
DyspneaRespiratory, thoracic and mediastinal disorders56/355
RashSkin and subcutaneous tissue disorders52/355
HeadacheNervous system disorders52/355
AnorexiaMetabolism and nutrition disorders45/355
CoughRespiratory, thoracic and mediastinal disorders45/355

Baseline characteristics

116 subjects enrolled in the Indolent subtype, however 109 subjects began treatment. Baseline characteristics for the Indolent subtype were based off of 109 subjects on treatment. This explains the discrepancy between the Participant Flow and the Overall Number of Baseline Participants.

Age, Continuous
Age, Continuous(years)Dasatinib, 70 mg, Twice Daily
Aggressive subtype52 (14.8 to 87.3)
GIST60 (19 to 78)
Indolent54 (22 to 87)
Sex: Female, Male
Sex: Female, Male(Participants)Dasatinib, 70 mg, Twice Daily
Aggressive subtype — Female96
Aggressive subtype — Male104
GIST — Female19
GIST — Male31
Indolent — Female33
Indolent — Male76
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Dasatinib, 70 mg, Twice Daily
Aggressive subtype — White171
Aggressive subtype — Black15
Aggressive subtype — Asian6
Aggressive subtype — Other6
Aggressive subtype — Unknown2
Aggressive subtype — Native American0
GIST — White41
GIST — Black3
GIST — Asian3
GIST — Other1
GIST — Unknown1
GIST — Native American1
Indolent — White94
Indolent — Black8
Indolent — Asian3
Indolent — Other4
Indolent — Unknown0
Indolent — Native American0
08

Study locations

20 sites
  • Arkansas Children's Hospital
    Little Rock, Arkansas 72202, United States
  • City of Hope
    Duarte, California 91010, United States
  • Cedars-Sinai Outpatient Cancer Center
    Los Angeles, California 90048, United States
  • Stanford University
    Palo Alto, California 94304, United States
  • Sarcoma Oncology Center
    Santa Monica, California 90403, United States
  • Washington Cancer Institute
    Washington, District of Columbia 20010, United States
  • Winship Cancer Institute at Emory University
    Atlanta, Georgia 30308, United States
  • Kootenai Cancer Center
    Coeur d'Alene, Idaho 83814, United States
  • Oncology Specialists
    Park Ridge, Illinois 60068, United States
  • Indiana University Cancer Center
    Indianapolis, Indiana 46202, United States
  • University of Iowa Hospitals and Clinics
    Iowa City, Iowa 52242, United States
  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
    Baltimore, Maryland 21231, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Dana Farber Cancer Institute
    Boston, Massachusetts 02115, United States
  • University of Michigan
    Ann Arbor, Michigan 48109, United States
  • Nebraska Methodist Hospital
    Omaha, Nebraska 68114, United States
  • Pennsylvania Oncology Hematology Associates
    Philadelphia, Pennsylvania 19106, United States
  • Fox Chase Cancer Center
    Philadelphia, Pennsylvania 19111, United States
  • University of Pittsburgh Cancer Institute
    Pittsburgh, Pennsylvania 15232, United States
  • MD Anderson
    Houston, Texas 77030, United States
09

References and documents

Related links

10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2007, a primary completion of Dec 2016 and a completion of May 2017. It does not say whether these dates are actual or estimated.

Results were first posted in Nov 2018, 1 year 11 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 20, 2007
First posted
Apr 23, 2007
Start
May 2007
Primary completionActual
Dec 2016
CompletionActual
May 2017
Results first posted
Nov 23, 2018
Last update
Nov 23, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00464620
Lead sponsor
Sarcoma Alliance for Research through Collaboration
Collaborators
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Apr 23, 2007
Start date
May 2007
Primary completion
Dec 2016
Completion
May 2017
Results posted
Nov 23, 2018
Last update
Nov 23, 2018

Study contacts

Scott Schuetze, MD, PhD
principal investigator · University of Michigan

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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