Reference Detail

Ref Type Journal Article
PMID (26710211)
Authors 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
Title SARC009: Phase 2 study of dasatinib in patients with previously treated, high-grade, advanced sarcoma.
Journal Cancer
Vol 122
Issue 6
Date 2016 Mar 15
URL
Abstract Text Dasatinib exhibited activity in preclinical models of sarcoma. The Sarcoma Alliance for Research through Collaboration (SARC) conducted a multicenter, phase 2 trial of dasatinib in patients with advanced sarcoma.Patients received dasatinib twice daily. The primary objective was to estimate the clinical benefit rate (CBR) (complete response or partial response within 6 months or stable disease duration of ≥6 months) with a target of ≥25%. Patients were enrolled into 1 of 7 different cohorts and assessed by imaging every 8 weeks using Choi criteria tumor response and a Bayesian hierarchical design. For each subtype, enrollment was stopped after a minimum of 9 patients were treated if there was a <1% chance the CBR was ≥25%.A total of 200 patients were enrolled. Accrual was stopped early in 5 cohorts because of low CBR. The leiomyosarcoma (LMS) and undifferentiated pleomorphic sarcoma (UPS) cohorts fully accrued and 6 of 47 and 8 of 42 evaluable patients, respectively, exhibited clinical benefit. The probability that the CBR was ≥25% in the LMS and UPS cohorts was 0.008 and 0.10, respectively. The median progression-free survival ranged from 0.9 months in patients with rhabdomyosarcoma to 2.2 months in patients with LMS. The median overall survival was 8.6 months. The most frequent adverse events were constitutional, gastrointestinal, and respiratory, and 36% of patients required dose reduction for toxicity. Serious adverse events attributed to therapy occurred in 11% of patients.Dasatinib may have activity in patients with UPS but is inactive as a single agent in the other sarcoma subtypes included herein. The Bayesian design allowed for the early termination of accrual in 5 subtypes because of lack of drug activity.

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Therapy Description
Drug Name Trade Name Synonyms Drug Classes Drug Description
Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown liposarcoma not applicable Dasatinib Phase II Actionable In a Phase II clinical trial, a trial arm assessing Sprycel (dasatinib) in liposarcoma patients (n=11) was suspended due to lack of drug activity (PMID: 26710211). 26710211
Unknown unknown malignant peripheral nerve sheath tumor not applicable Dasatinib Phase II Actionable In a Phase II clinical trial, a trial arm assessing Sprycel (dasatinib) in patients with malignant peripheral nerve sheath tumors (n=14) was suspended due to lack of drug activity (PMID: 26710211). 26710211
Unknown unknown leiomyosarcoma not applicable Dasatinib Phase II Actionable In a Phase II clinical trial, 13% (6/42) of patients with leiomyosarcoma demonstrated clinical benefit with a median progression free survival of 2.2 months when treated with Sprycel (dasatinib) but were below levels considered to result from drug activity (PMID: 26710211). 26710211
Unknown unknown bone Ewing's sarcoma not applicable Dasatinib Phase II Actionable In a Phase II clinical trial, a trial arm assessing Sprycel (dasatinib) in Ewing sarcoma patients (n=17) was suspended due to lack of drug activity (PMID: 26710211). 26710211
Unknown unknown osteosarcoma not applicable Dasatinib Phase II Actionable In a Phase II clinical trial, a trial arm assessing Sprycel (dasatinib) in osteosarcoma patients (n=46) was suspended due to lack of drug activity (PMID: 26710211). 26710211
Unknown unknown rhabdomyosarcoma not applicable Dasatinib Phase II Actionable In a Phase II clinical trial, a trial arm assessing Sprycel (dasatinib) in rhabdomyosarcoma patients (n=13) was suspended due to lack of drug activity (PMID: 26710211). 26710211
Unknown unknown sarcoma not applicable Dasatinib Phase II Actionable In a Phase II clinical trial, 19% (8/42) of patients with undifferentiated pleomorphic sarcoma demonstrated clinical benefit when treated with Sprycel (dasatinib), however the 6 month progression free survival rate in patients was only 12% (6/42) (PMID: 26710211). 26710211