Trial Search Results

Trial of Dasatinib in Advanced Sarcomas

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

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Sarcoma Alliance for Research through Collaboration

Collaborator: Bristol-Myers Squibb


  • Drug: Dasatinib


Phase 2


Inclusion Criteria:

   1. Unresectable, recurrent, or metastatic histologically-confirmed soft tissue or bone
   sarcoma of one of the following subtypes:

      - Leiomyosarcoma --* NO LONGER ELIGIBLE*

      - Liposarcoma--* NO LONGER ELIGIBLE*

      - Malignant fibrous histiocytoma (MFH)/pleomorphic undifferentiated sarcoma--* NO

      - Rhabdomyosarcoma --* NO LONGER ELIGIBLE*

      - Malignant peripheral nerve sheath tumor (MPNST) --* NO LONGER ELIGIBLE*

      - Osteosarcoma (skeletal or extraosseous)--* NO LONGER ELIGIBLE*

      - Ewing's --* NO LONGER ELIGIBLE*

      - Chondrosarcoma

      - Alveolar soft part sarcoma

      - Chordoma

      - Epithelioid sarcoma

      - Giant cell tumor of bone

      - Hemangiopericytoma/solitary fibrous tumor

      - Gastrointestinal Stromal Tumor (GIST) --* NO LONGER ELIGIBLE*

   2. Documentation that subjects with leiomyosarcoma, liposarcoma, osteosarcoma, Ewing's,
   MPNST, rhabdomyosarcoma or MFH have received, not been eligible for or refused at
   least one prior chemotherapy regimen before participation in the dasatinib study.
   Subjects with GIST must have received or been intolerant to imatinib; prior treatment
   with other agents including sunitinib is not required.Neoadjuvant/adjuvant
   chemotherapy qualifies as prior therapy.

   3. Subjects must have unidimensionally measurable lesion(s) either by x-ray, computed
   tomography (CT), magnetic resonance imaging (MRI) or physical examination documented
   within 30 days prior to registration.

   4. Prior radiation will be allowed. More than two weeks should have elapsed since the
   administration of the last fraction of radiation therapy, and subjects must have
   recovered from grade 2 or higher associated toxicities. Measurable lesions, which are
   selected as target lesions, must be outside previously radiated fields or have
   documented progression no sooner than 6 weeks after completion of radiation.

   5. More than 2 weeks must have elapsed since the subject has received any prior systemic
   chemotherapy (6 weeks for mitomycin C), and the patient should have recovered from
   toxicities to the baseline prior to the last course of chemotherapy.

   6. Adequate hematologic function within 14 days prior to registration.

   7. PT (or INR) and PTT ≤ 1.5 times the institutional ULN within 14 days prior to

   8. Serum creatinine ≤ 2.0 times the institutional ULN within 14 days prior to

   9. Serum magnesium, potassium and adjusted (or ionized) calcium ≥ the institutional LLN.
   (Supplementation of electrolytes prior to screening is allowed).

10. Left ventricular ejection fraction ≥ 45% measured by echocardiogram or multiple gated
   acquisition (MUGA) within 30 days prior to registration (but must be performed after
   the last dose of an anthracycline) for subjects who have received an anthracycline
   (e.g. doxorubicin, epirubicin) or have a medical history of cardiac disease. The
   measurement of left ventricular ejection fraction is not required of subjects whom
   have not received cardiotoxic chemotherapy (e.g. anthracycline) and do not have a
   medical history of cardiac disease.

11. Sexually active women and men of childbearing potential must agree to use an effective
   method of birth control during the course of the study and for up to 3 months
   following the last dose of the study drug, in a manner such that risk of pregnancy is
   minimized. Surgical sterilization, intrauterine device or barrier method (e.g. condom
   and/or diaphragm with spermicidal agents) are acceptable forms of birth control.

12. Women of childbearing potential must have a negative pregnancy test (urine or serum)
   within 7 days prior to treatment. A pregnancy test is not required for registration.
   Women who have not menstruated for more than 2 years will be considered
   postmenopausal, thus not of childbearing potential.

13. 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

16. Subjects must be able to swallow whole tablets.

17. Subjects must be informed of the investigational nature of the study and provide
   written, informed consent and authorization to release protected health information
   using a document(s) approved by the investigator's institution.

18. A paraffin block, either from a previous surgery or recent biopsy, should be available
   for correlative studies. If a block of tumor is not available, at least 8 unstained
   slides of tumor sample, 1 H&E and three (3) 15 micron-thick sections in an eppendorf
   tube for DNA extraction from a representative portion of the sarcoma may be
   substituted after discussion with and approval from the study Principal Investigator.

Exclusion Criteria:

   1. Subjects who are curable by conventional multidisciplinary management.

   2. Subjects with symptomatic central nervous system metastasis.

   3. Women who are pregnant or nursing/breastfeeding.

   4. History of significant bleeding disorder unrelated to cancer, including:

      - Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)

      - Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor
      VIII antibodies)

   5. Subjects currently taking medications that inhibit platelet function (i.e., aspirin,
   dipyridamole, epoprostenol, eptifibatide, clopidogrel, cilostazol, abciximab,
   ticlopidine, and any non-steroidal anti-inflammatory drug) because of a potential
   increased risk of bleeding from dasatinib.

   6. Subjects currently taking anticoagulants (warfarin, heparin/low molecular weight
   heparin [e.g., danaparoid, dalteparin, tinzaparin, enoxaparin]) because of a potential
   increased risk of bleeding from dasatinib.

   7. Diagnosis of unstable angina or myocardial infarction within 6 months of study entry.

   8. Subjects currently taking one or more of the following drugs that are generally
   accepted to have a risk of causing Torsades de Pointes:

      - Quinidine, procainamide, disopyramide

      - Amiodarone, sotalol, ibutilide, dofetilide

      - Erythromycins, clarithromycin

      - Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide

      - Cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone,
      halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine.

   9. Diagnosed or suspected congenital long QT syndrome.

10. Prolonged QTc interval on pre-entry electrocardiogram (> 450 msec) within 30 days
   prior to study registration.

11. Subjects unable or unwilling to suspend treatment with bisphosphonates for at least
   the first 8 weeks of treatment with study drug because of the risk of hypocalcemia
   caused by dasatinib.

Ages Eligible for Study

13 Years - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
Not Recruiting