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Clinical Trial Summary

A two-cohort, fase II, open-label, non-randomized, multicenter clinical trial. 14 sites in Spain. Cohort 1: Subjects with desmoid tumor (DT) Cohort 2: Subjects with desmoplastic small round cell tumor or Ewing sarcoma (DSRCT and ES) Nab-paclitaxel (ABRAXANE) will be administered as follows: Age ≥ 21 and ≤ 80 years: 125 mg/m2 days 1, 8 and 15 in cycles of 28 days Age ≥ 6 months and ≤ 20 years: 240 mg/m2 days 1, 8 and 15 in cycles of 28 days Subjects in the DT cohort will receive a maximum of three cycles. Subjects in the DSRCT and ES cohort will receive unlimited cycles until disease progression, the subject begins a new anticancer treatment, withdrawal of parent/guardian/subject consent/assent, parent/guardian/subject refusal, physician decision, toxicity that cannot be managed by dose delay or dose reduction alone or the study ends for any reason. The main goal is to determine the objective response rate (ORR), using RECIST 1.1 criteria and to determine the clinical benefit rate (CBR), defined as CR+PR+SD for 3 months with improvement of pain with at least minimally important difference (MID) of 2 in subjects with desmoid tumors (DT cohort) and to determine the objective response rate (ORR) in subjects with desmoplastic small round cell tumor and Ewing sarcoma, using RECIST 1.1 criteria (DSRCT and ES cohort)


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms

  • Desmoid
  • Desmoplastic Small Round Cell Tumor
  • Neoplasms
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Sarcoma
  • Sarcoma, Ewing
  • Tumor, Desmoplastic Small Round Cell, Adult
  • Tumor, Desmoplastic Small Round Cell, Childhood

NCT number NCT03275818
Study type Interventional
Source Grupo Espanol de Investigacion en Sarcomas
Contact
Status Completed
Phase Phase 2
Start date May 9, 2017
Completion date September 30, 2021

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