Trial of Dasatinib in Advanced Sarcomas

TYPE OF SARCOMA: Leiomyosarcoma, liposarcoma, MFH/pleomorphic undifferentiated sarcoma, rhabdomyosarcoma, malignant peripheral nerve sheath tumor, osteosarcoma (skeletal or extraosseous), chondrosarcoma, ewing’s, alveolar soft part sarcoma, chordoma, epithelioid sarcoma, giant cell tumor of bone, hemangiopericytoma/solitary fibrous tumor, gastrointestinal stromal tumors (GIST)
DRUG: Dasatinib
ACCRUAL STATUS: Completed

OVERALL STUDY PRINCIPAL INVESTIGATOR:
Scott Schuetze, MD, PhD
University of Michigan

CLINICALTRIALS.GOV IDENTIFIER: NCT00464620

FOR STUDY DETAILS AND ELIGIBILITY CRITERIA: CLINICALTRIALS.GOV

IMPACT STATEMENT:
SARC009 sought to determine if treatment of soft tissue or bone sarcoma with dasatinib resulted in anti-sarcoma activity through change in the size and density of tumor. Patients were enrolled into sarcoma sub-type specific treatment cohorts with enrollment proceeding if there was evidence of drug activity in patients treated early in the trial and stopping if no anti-sarcoma activity was seen (Bayesian enrollment design). Sarcoma response was seen in patients with chordoma, chondrosarcoma, undifferentiated pleomorphic sarcoma, leiomyosarcoma and gastrointestinal stromal tumor. SARC009 was one of the first studies to demonstrate that evaluation of chemotherapy could be successfully accomplished in histology specific cohorts in rare sarcomas.

PUBLICATION:
Schuetze SM, Bolejack V, Thomas DG, von Mehren M, Patel S, Samuels B, Choy E, D’Amato G, Staddon AP, Ganjoo KN, Chow WA, Rushing DA, Forscher CA, Priebat DA, Loeb DM, Chugh R, Okuno S, Reinke DK, Baker LH. Association of Dasatinib With Progression-Free Survival Among Patients With Advanced Gastrointestinal Stromal Tumors Resistant to Imatinib. JAMA Oncol. 2018 Jun 1;4(6):814-820. doi: 10.1001/jamaoncol.2018.0601. PMID: 29710216; PMCID: PMC6145709.

Schuetze SM, Bolejack V, Choy E, Ganjoo KN, Staddon AP, Chow WA, Tawbi HA, Samuels BL, Patel SR, von Mehren M, D’Amato G, Leu KM, Loeb DM, Forscher CA, Milhem MM, Rushing DA, Lucas DR, Chugh R, Reinke DK, Baker LH. Phase 2 study of dasatinib in patients with alveolar soft part sarcoma, chondrosarcoma, chordoma, epithelioid sarcoma, or solitary fibrous tumor. Cancer. 2017 Jan 1;123(1):90-97. doi: 10.1002/cncr.30379. Epub 2016 Oct 3. PMID: 27696380.

Schuetze SM, Wathen JK, Lucas DR, Choy E, Samuels BL, Staddon AP, Ganjoo KN, von Mehren M, Chow WA, Loeb DM, Tawbi HA, Rushing DA, Patel SR, Thomas DG, Chugh R, Reinke DK, Baker LH. SARC009: Phase 2 study of dasatinib in patients with previously treated, high-grade, advanced sarcoma. Cancer. 2016 Mar 15;122(6):868-74. doi: 10.1002/cncr.29858. Epub 2015 Dec 28. PMID: 26710211.

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