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Brief Title: Trial of Pazopanib in Patients With Solitary Fibrous Tumor and Extraskeletal Myxoid Chondrosarcoma
Official Title: A Phase II Open-Label Trial of Pazopanib Administered as a Single Agent in Patients With Unresectable or Metastatic Solitary Fibrous Tumor (SFT) and Extraskeletal Myxoid Chondrosarcoma (EMC)
Study ID: NCT02066285
Brief 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continue to receive treatment until there is evidence of progressive disease, unacceptable toxicity, non-compliance, withdrawn consent or investigator decision.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.
Detailed Description: To estimate the sample size for stratum 1 (SFT), a Simon's optimal 2-stage phase II design has been used, having considered the published response rate based on Choi criteria in SFT patients which correspond to 40% in monotherapy. For a design with P0=0.40, P1=0.60; ι=0.1 and β=0.1. At the first stage, 18 patients should be enrolled into the study, if there are fewer than 8 responses (7 or less) the trial will be terminated and it will be concluded that pazopanib is not sufficiently active. At the second stage, another 28 patients (total 46 patients) would be enrolled into the study. To reject the null hypothesis for the SFT stratum 23 responses or more (Choi criteria), out of the 46 patients, are needed. To estimate the simple size for stratum 2 (EMC), a Simon's optimal 2-stage phase II design has been used, having considered the very scarce published information on response rate based on RECIST criteria. For a design with P0= 0.05, P1= 0.25, ι=0.1 and β=0.1. At the first stage, 9 patients should be enrolled into the study, if there are not responses the trial will be terminated and it will be concluded that pazopanib is not sufficiently active. If there is at least 1 response in this first stage, the trial will be continued and at the second stage, another 15 patients (total 24 patients) would be enrolled into the study. To reject the null hypothesis for the EMC stratum 3 responses or more (RECIST criteria), out of the 24 patients, are needed. For variables that follow binomial distributions (e.g. response rate) frequency and percentages will be calculated, together with their corresponding exact 95% confidence intervals. For time-to-event variables (e.g. PFS or OS) Kaplan-Meier estimations will be used. To analyze the reduction of risk and the influence of other variables on time-to-event variables Cox Regression will be applied. To correlate pharmacodynamics markers and biomarkers with clinical response standard methods for bivariate and multivariate regression and correlation will be used.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
H. Son Espases, Palma De Mallorca, Islas Baleares, Spain
H. Universitario de Canarias, Tenerife, Santa Cruz De Tenerife, Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital La Paz, Madrid, , Spain
Hospital RamĂłn y Cajal, Madrid, , Spain
Hospital Universitario Virgen del RocĂo, Sevilla, , Spain
H. Miguel Servet, Zaragoza, , Spain
Name: Josefina Cruz, MD
Affiliation: Hospital Universitario de Canarias
Role: STUDY_DIRECTOR
Name: Javier MartĂn, MD
Affiliation: Hospital Son Espases
Role: STUDY_DIRECTOR
Name: Antonio LĂłpez-Pousa, MD
Affiliation: Hospital Sant Pau
Role: PRINCIPAL_INVESTIGATOR
Name: M. Ăngeles Vaz, MD
Affiliation: Hospital Universitario Ramon y Cajal
Role: PRINCIPAL_INVESTIGATOR
Name: AndrĂŠs Redondo, MD
Affiliation: Hospital La Paz
Role: PRINCIPAL_INVESTIGATOR
Name: Javier MartĂnez-Trufero, MD
Affiliation: Hospital Miguel Servet
Role: PRINCIPAL_INVESTIGATOR
Name: Pilar Blay, MD
Affiliation: Hospital Central de Asturias
Role: PRINCIPAL_INVESTIGATOR
Name: Pilar Sancho, MD
Affiliation: Hospital Virgen del RocĂo
Role: PRINCIPAL_INVESTIGATOR
Name: Jean Yves Blay, MD
Affiliation: Centre Leon Berard
Role: PRINCIPAL_INVESTIGATOR
Name: Silvia Stacchiotti, MD
Affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Role: STUDY_DIRECTOR