CompletedPhase 2

Trial of Dasatinib in Advanced Sarcomas

United States366 participantsStarted 2007-05

Plain-language summary

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

Who can participate

Age range13 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Unresectable, recurrent, or metastatic histologically-confirmed soft tissue or bone sarcoma of one of the following subtypes:
✓. 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.
✓. 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.
✓. 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.
✓. 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.
✓. Adequate hematologic function within 14 days prior to registration.
✓. Prothrombin Time (PT) (or INR) and Partial Thromboplastin Time (PTT) ≤ 1.5 times the institutional upper limit of normal (ULN) within 14 days prior to registration.
✓. Serum creatinine ≤ 2.0 times the institutional ULN within 14 days prior to registration.

Exclusion criteria

✕. Subjects who are curable by conventional multidisciplinary management.
✕. Subjects with symptomatic central nervous system metastasis.
✕. Women who are pregnant or nursing/breastfeeding.
✕. History of significant bleeding disorder unrelated to cancer, including:
✕. 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.
✕. 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.
✕. Diagnosis of unstable angina or myocardial infarction within 6 months of study entry.
✕. Subjects currently taking one or more of the following drugs that are generally accepted to have a risk of causing Torsades de Pointes:

What they're measuring

Response Rate: Number of Participants With Objective Tumor Response

Timeframe: Up to 24 months

6 Month Progression-free Survival Rate of "Indolent" Sarcomas Treated With Dasatinib

Timeframe: At 6 months

6 Month Progression-free Survival Rate of Gastrointestinal Stromal Tumors (GIST)

Timeframe: 6 months

Trial details

NCT IDNCT00464620

SponsorSarcoma Alliance for Research through Collaboration

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-12

Results submitted2018-08-03

View on ClinicalTrials.gov More Rhabdomyosarcoma trials