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Trial of Pazopanib in Patients With Solitary Fibrous Tumor and Extraskeletal Myxoid Chondrosarcoma

NCT02066285 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2023-03-27

No results posted yet for this study

Summary

Phase II, open-label, non-randomized, international multicenter clinical trial with two strata (SFT and EMC). 8 sites in Spain, 5 sites in Italy and 5 sites in France. Patients will receive oral pazopanib at 800 mg once daily continuously. Patients will continue to receive treatment until there is evidence of progressive disease, unacceptable toxicity, non-compliance, withdrawn consent or investigator decision. The main goal is to determine the objective response rate (ORR) (confirmed complete response \[CR\] and partial response \[PR\]) in patients with unresectable, locally advanced or metastatic solitary fibrous tumor and extraskeletal myxoid chondrosarcoma, using Choi and RECIST 1.1 criteria respectively.

Conditions

  • Solitary Fibrous Tumor
  • Extraskeletal Myxoid Chondrosarcoma

Interventions

DRUG

Pazopanib

Treatment will continue until disease progression, development of unacceptable toxicity, non-compliance, withdrawal of consent by the patient or investigator decision.

Sponsors & Collaborators

  • Grupo Espanol de Investigacion en Sarcomas

    lead OTHER

Principal Investigators

  • Josefina Cruz, MD · Hospital Universitario de Canarias

  • Javier Martín, MD · Hospital Son Espases

  • Antonio López-Pousa, MD · Hospital Sant Pau

  • M. Ángeles Vaz, MD · Hospital Universitario Ramon y Cajal

  • Andrés Redondo, MD · Hospital La Paz

  • Javier Martínez-Trufero, MD · Hospital Miguel Servet

  • Pilar Blay, MD · Hospital Central de Asturias

  • Pilar Sancho, MD · Hospital Virgen del Rocío

  • Jean Yves Blay, MD · Centre Leon Berard

  • Silvia Stacchiotti, MD · Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2019-12-31
Completion
2023-03-24

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02066285 on ClinicalTrials.gov