Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Solitary Fibrous Tumors

Hemangiopericytoma

Neoplasms, Fibrous Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Vascular Tissue

Antineoplastic Agents

All Drugs and Chemicals

Axitinib

Protein Kinase Inhibitors

Enzyme Inhibitors

Axitinib will be administered at the dose of 5mg twice a day, continuously. Treatment will be continued till evidence of progression, or toxicities or patient withdrawal.

Silvia Stacchiotti, MD

This is an investigator initiated, open label, prospective, non-randomized, phase II trial aimed at evaluating the activity of Axitinib in progressive VEGFR2 and/or PDGFRB positive advanced Solitary Fibrous Tumor (SFT) patients. Patients with a documented and centrally reviewed pathologic and radiologic diagnosis of progressive VEGFR2 and/or PDGFRB positive advanced SFT may enter in the study. Axitinib will be administered at the dose of 5mg twice a day, continuously. Treatment will be continued till evidence of progression, or toxicities or patient withdrawal.

This is an investigator initiated, open label, prospective, non-randomized, phase II trial aimed at evaluating the activity of Axitinib in progressive VEGFR2 and/or PDGFRB positive advanced Solitary Fibrous Tumor (SFT) patients. Patients with a documented and centrally reviewed pathologic and radiologic diagnosis of progressive VEGFR2 and/or PDGFRB positive advanced SFT may enter in the study. Axitinib will be administered at the dose of 5mg twice a day, continuously. Treatment will be continued till evidence of progression, or toxicities or patient withdrawal.

The activity of Axitinib will be evaluated in terms of overall response rate according to Choi Criteria as defined for GIST patients treated with Imatinib, extended even to MRI.

Secondary objectives of the study will be: response rate by RECIST, progression free survival, overall survival, clinical benefit (RECIST Complete Response + Partial Response + Stable Disease \>6 months). Whenever possible a post-treatment biopsy will be performed to assess Axitinib targets status after treatment and to correlate their status to the response.

Tumor assessment with CT scan and/or MRI will be performed within 4 weeks prior to first dose of Axitinib and after 4 weeks from starting treatment, then every 2 months until progression or toxicity.

As per protocol the experimental treatment can be administered in front or further line.

The study will be considered positive if 30% of response rate by Choi criteria is observed. To this end a maximum of 16 evaluable patients will be enrolled in two years.

In case of positive study the trial will be re-open to confirm the result in a larger number of patients.

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Phase II Study on Axitinib in Advanced Solitary Fibrous Tumor

Phase II Study on Axitinib in Advanced VEGFR and/or PDGFR Solitary Fibrous Tumor

Evaluation of clinical benefit according to response rate, overall survival, progression free survival

assessment of the safety profile of Axitinib in agreement with the incidence of related adverse events.

response rate, according to Choi Criteria

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Sarcoma

Soft Tissue Sarcoma

Eribulin will be administered at the dose of 1.23 mg/m², intravenously over 2-5 min on day 1 and day 8 of every 21 day cycle.

Study treatment will be administered until evidence of progression or unacceptable toxicity, patient's own willingness, non-compliance or according to clinical investigator's decision.

Eribulin

Noemi Simone, MD

Giuseppe Badalamenti, MD

Badalamenti

Bruno Vincenzi, MD

Phase II study on advanced Solitary Fibrous Tumor (SFT) treated with eribulin

This is an Italian, non randomized, open label, multi center, investigator-initiated, Phase II, clinical study to explore the activity of eribulin in a population of patients with progressive, advanced (i.e. locally advanced or metastatic), molecularly proven SFT. Patients with a documented and centrally reviewed pathological diagnosis of locally advanced or metastatic SFT, and with an evidence of progression within the previous 6 months, may enter the study.

Study treatments will be administered till progression or toxicity. The primary end-point of the study is overall response rate Secondary end-points are Progression Free Survival (PFS), Overall Survival (OS) clinical benefit rate, response rate as by Choi criteria, duration of response.

Subjects already treated with one or two prior medical therapy regimens for the advanced phase, whatever agent used in first- or second-line, are eligible for inclusion in the study. Investigators will consider eligible for this study even patients naïve from chemotherapy, considering the limited activity of anthracycline in the disease.

Eribulin in Advanced Solitary Fibrous Tumor

ERibulin in Advanced Solitary Fibrous Tumor, an ItaliaN Sarcoma Group Phase II Study (ERASING)

Proportion of patients with tumor size reduction ⩾ to 30% measured with RECIST Criteria 1.1

Proportion of patients with tumor size reduction ⩾10% or a decrease in tumour attenuation⩾15% measured with Choi criteria

Survival from the first eribulin dose to death for any cause

Proportion of patients with no disease progression after 18 weeks of therapy.

Safety in term of adverse event is evaluate from the first eribulin dose throughout the study according to CTCAE 5.0

Eisai Inc.

Italian Sarcoma Group

Symptoms and General Pathology

Neoplasm Metastasis

Chondrosarcoma

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.

Pazopanib

Josefina Cruz, MD

Javier Martín, MD

Antonio López-Pousa, MD

M. Ángeles Vaz, MD

Andrés Redondo, MD

Javier Martínez-Trufero, MD

Pilar Blay, MD

Pilar Sancho, MD

Jean Yves Blay, MD

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.

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.

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

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)

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 measured by the progression-free survival (PFS) rate assessed by median time

Overall survival (OS) measured since treatment start date until date of death, whichever the cause

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, 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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase II Study on Axitinib in Advanced Solitary Fibrous Tumor	NCT02261207	Solitary Fibrou...	Axitinib	18 Years -	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Eribulin in Advanced Solitary Fibrous Tumor	NCT03840772	Solitary Fibrou...	Eribulin	18 Years -	Italian Sarcoma Group
Trial of Pazopanib in Patients With Solitary Fibrous Tumor and Extraskeletal Myxoid Chondrosarcoma	NCT02066285	Solitary Fibrou... Extraskeletal M...	Pazopanib	18 Years -	Grupo Espanol de Investigacion en Sarcomas

Spots Global Cancer Trial Database for solitary fibrous tumor