Trial of Pazopanib in Patients With Solitary Fibrous Tumor and Extraskeletal Myxoid Chondrosarcoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02066285|
Recruitment Status : Active, not recruiting
First Posted : February 19, 2014
Last Update Posted : September 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Solitary Fibrous Tumor Extraskeletal Myxoid Chondrosarcoma||Drug: Pazopanib||Phase 2|
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; α=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, α=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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||June 2014|
|Actual Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||June 2020|
Single arm of pazopanib 800 mg (2x400 mg or 4x200 mg) given as a single agent once daily continuously.
Treatment will continue until disease progression, development of unacceptable toxicity, non-compliance, withdrawal of consent by the patient or investigator decision.
Other Name: Votrient
- Objective response rate (ORR) [ Time Frame: 48 weeks ]Objective response rate (ORR) (confirmed complete response [CR] and partial response [PR]), measured using Choi and RECIST 1.1 criteria. Response criteria will be based on the baseline identification of target lesions and follow-up until tumor progression.
- Efficacy of pazopanib [ Time Frame: 48 weeks ]Efficacy measured by the progression-free survival (PFS) rate assessed by median time
- Overall survival (OS) [ Time Frame: 72 weeks ]Overall survival (OS) measured since treatment start date until date of death, whichever the cause
- Clinical benefit rate (CBR) [ Time Frame: 48 weeks ]Clinical benefit rate (CBR). Patients who have reached CR, PR or SD during 6 months or more, presenting clinical improvement of symptoms, will be considered as having experienced clinical benefit.
- Long term safety profile of pazopanib [ Time Frame: 48 weeks ]Long term safety profile of pazopanib, through assessment of adverse event type, incidence, severity, time of appearance, related causes, as well as physical explorations and laboratory tests. Toxicity will be graded and tabulated by using NCI-CTCAE 4.0.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02066285
|H. Son Espases|
|Palma De Mallorca, Islas Baleares, Spain|
|H. Universitario de Canarias|
|Tenerife, Santa Cruz De Tenerife, Spain, 38320|
|Hospital de la Santa Creu i Sant Pau|
|Hospital La Paz|
|Hospital Ramón y Cajal|
|Hospital Universitario Virgen del Rocío|
|Sevilla, Spain, 41013|
|H. Miguel Servet|
|Study Director:||Josefina Cruz, MD||Hospital Universitario de Canarias|
|Study Director:||Javier Martín, MD||Hospital Son Espases|
|Principal Investigator:||Antonio López-Pousa, MD||Hospital Sant Pau|
|Principal Investigator:||M. Ángeles Vaz, MD||Hospital Universitario Ramon y Cajal|
|Principal Investigator:||Andrés Redondo, MD||Hospital La Paz|
|Principal Investigator:||Javier Martínez-Trufero, MD||Hospital Miguel Servet|
|Principal Investigator:||Pilar Blay, MD||Hospital Central de Asturias|
|Principal Investigator:||Pilar Sancho, MD||Hospital Virgen del Rocío|
|Principal Investigator:||Jean Yves Blay, MD||Centre Leon Berard|
|Study Director:||Silvia Stacchiotti, MD||Fondazione IRCCS Istituto Nazionale dei Tumori, Milano|