Solitary Fibrous TumorPhase 2NCT02066285
Trial of Pazopanib in Patients With Solitary Fibrous Tumor and Extraskeletal Myxoid Chondrosarcoma
A Phase 2 study testing Pazopanib in people with Solitary Fibrous Tumor and Extraskeletal Myxoid Chondrosarcoma, run by Grupo Espanol de Investigacion en Sarcomas at 7 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solitary Fibrous Tumor, Extraskeletal Myxoid Chondrosarcoma
- What is being tested?
- Pazopanib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 7 sitesSpain
- Study dates
- Jun 2014to 24 Mar 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up.
- Age ≥ 18 years or legal age of consent if greater than 18 years.
- Histologic diagnosis of solitary fibrous tumor (stratum 1) or extraskeletal myxoid chondrosarcoma (stratum 2) (unresectable, locally advanced or metastatic disease) confirmed by central pathology review.
- Patients with metastatic tumor suitable for complete resection can be recruited. In absence of progressive disease these patients should be treated with the study drug for at least 6 months.
- For patients who have received previous anticancer treatments, progressive disease must be demonstrated within 6 months prior to enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
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- Measurable disease according to Choi (SFT) and RECIST 1.1 (EMC) criteria.
- Patients could have received a maximum of 4 lines of chemotherapy for metastatic disease prior to trial enrollment.
- Patients must be able to swallow and retain the study drug.
- Adequate organ system function as defined in protocol.
- Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of first dose of study treatment. All patients (both male and female) must agree to use effective contraception methods, as defined in the protocol.
- Left ventricular ejection fraction (LVEF) above the lower limit of normal for the institution, either by echocardiogram or MUGA.
- Patients in France will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
Who cannot join
- Prior malignancy, except patients who have had another malignancy and have been disease-free for 10 years, or those with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma.
- Central nervous system metastases at baseline, with the exception of patients who have previously-treated central nervous system metastases (surgery ± radiotherapy, radiosurgery, or gamma knife) and who meet both of the following criteria: a) are asymptomatic and b) have no requirement for steroids or enzyme-inducing anticonvulsants in prior 6-month time interval.
- Patients who have received previous antiangiogenic agents.
- Significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding.
- Significant gastrointestinal abnormalities that may affect absorption of investigational product.
- Corrected QT interval (QTc) > 480 msecs.
Show all 21Show fewer
- History of any one or more of the following cardiovascular conditions within the past 6 months:
- Cardiac angioplasty or stenting Myocardial infarction Unstable angina Coronary artery bypass graft surgery Symptomatic peripheral vascular disease Class II, III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
- Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥140 mmHg or diastolic blood pressure (DBP) of ≥ 90mmHg].
- History of cerebrovascular accident.
- Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer (catheter placement and similar procedures are not considered to be major surgery).
- Evidence of active bleeding or bleeding diathesis.
- Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage.
- Recent hemoptysis (>=½ teaspoon of red blood within 8 weeks before first dose of study drug).
- Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with patient's safety, provision of informed consent, or compliance to study procedures.
- Unable or unwilling to discontinue use of prohibited medications listed in the protocol for at least 14 days or 5 half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study.
- Treatment with any of the following anti-cancer therapies:
- Radiation therapy, surgery or tumor embolization within 28 days prior to the first dose of pazoapnib or Chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib
- Administration of any non-oncologic drug within 30 days or 5 half-lives (whichever is longer) prior to receiving the first dose of study treatment.
- Ongoing toxicity from prior anti-cancer therapy that is >Grade 1 (except anemia, see Table 1 above) and/or that is progressing in severity, except alopecia.
- Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital La Paz
Madrid
Hospital Ramón y Cajal
Madrid
H. Son Espases
Palma de Mallorca, Balearic Islands
H. Universitario de Canarias
Santa Cruz de Tenerife, Santa Cruz De Tenerife, 38320
Hospital Universitario Virgen del Rocío
Seville, 41013
H. Miguel Servet
Zaragoza
About this study
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)
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.
Read the 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; 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.
- Being tested
- Pazopanib
- Keywords
- Solitary fibrous tumor, Extraskeletal myxoid chondrosarcoma, Unresectable, Locally advanced, Metastatic disease
- Medical subject headings
- Solitary Fibrous Tumors, Chondrosarcoma, Extraskeletal Myxoid, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PazopanibDrug
Also called Votrient
Treatment will continue until disease progression, development of unacceptable toxicity, non-compliance, withdrawal of consent by the patient or investigator decision.
| Study group | Role | What they receive |
|---|---|---|
| Pazopanib | Experimental | Single arm of pazopanib 800 mg (2x400 mg or 4x200 mg) given as a single agent once daily continuously. Receives: Drug: Pazopanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
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.
Measured: 48 weeks
Secondary outcomes (4)
Efficacy of pazopanib
Efficacy measured by the progression-free survival (PFS) rate assessed by median time
Measured: 48 weeks
Overall survival (OS)
Overall survival (OS) measured since treatment start date until date of death, whichever the cause
Measured: 72 weeks
Clinical benefit rate (CBR)
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.
Measured: 48 weeks
Long term safety profile of pazopanib
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.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2019
- Study completion24 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Solitary Fibrous TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo Espanol de Investigacion en Sarcomas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Josefina Cruz, MD, Study director, Hospital Universitario de CanariasJavier Martín, MD, Study director, Hospital Son EspasesAntonio López-Pousa, MD, Principal investigator, Hospital Sant PauM. Ángeles Vaz, MD, Principal investigator, Hospital Universitario Ramon y CajalAndrés Redondo, MD, Principal investigator, Hospital La PazJavier Martínez-Trufero, MD, Principal investigator, Hospital Miguel ServetPilar Blay, MD, Principal investigator, Hospital Central de AsturiasPilar Sancho, MD, Principal investigator, Hospital Virgen del Rocío
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02066285
- Sponsor's protocol ID
- GEIS-32
- Other IDs
- 2013-005456-15
- Status last verified
- Mar 2023
- First submitted
- 14 Feb 2014
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Napolitano A, Moura DS, Hindi N, Mondaza-Hernandez JL, Merino-Garcia JA, Ramos R, Dagrada GP, Stacchiotti S, Graziano F, Vincenzi B, Martin-Broto J. Expression of p53 as a biomarker of pazopanib efficacy in solitary fibrous tumours: translational analysis of a phase II trial. Ther Adv Med Oncol. 2022 Aug 6;14:17588359221116155. doi: 10.1177/17588359221116155. eCollection 2022.
PubMed 35965642Martin-Broto J, Cruz J, Penel N, Le Cesne A, Hindi N, Luna P, Moura DS, Bernabeu D, de Alava E, Lopez-Guerrero JA, Dopazo J, Pena-Chilet M, Gutierrez A, Collini P, Karanian M, Redondo A, Lopez-Pousa A, Grignani G, Diaz-Martin J, Marcilla D, Fernandez-Serra A, Gonzalez-Aguilera C, Casali PG, Blay JY, Stacchiotti S. Pazopanib for treatment of typical solitary fibrous tumours: a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2020 Mar;21(3):456-466. doi: 10.1016/S1470-2045(19)30826-5. Epub 2020 Feb 14.
PubMed 32066540Stacchiotti S, Ferrari S, Redondo A, Hindi N, Palmerini E, Vaz Salgado MA, Frezza AM, Casali PG, Gutierrez A, Lopez-Pousa A, Grignani G, Italiano A, LeCesne A, Dumont S, Blay JY, Penel N, Bernabeu D, de Alava E, Karanian M, Morosi C, Brich S, Dagrada GP, Vallacchi V, Castelli C, Brenca M, Racanelli D, Maestro R, Collini P, Cruz J, Martin-Broto J. Pazopanib for treatment of advanced extraskeletal myxoid chondrosarcoma: a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2019 Sep;20(9):1252-1262. doi: 10.1016/S1470-2045(19)30319-5. Epub 2019 Jul 19.
PubMed 31331701Martin-Broto J, Stacchiotti S, Lopez-Pousa A, Redondo A, Bernabeu D, de Alava E, Casali PG, Italiano A, Gutierrez A, Moura DS, Pena-Chilet M, Diaz-Martin J, Biscuola M, Taron M, Collini P, Ranchere-Vince D, Garcia Del Muro X, Grignani G, Dumont S, Martinez-Trufero J, Palmerini E, Hindi N, Sebio A, Dopazo J, Dei Tos AP, LeCesne A, Blay JY, Cruz J. Pazopanib for treatment of advanced malignant and dedifferentiated solitary fibrous tumour: a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2019 Jan;20(1):134-144. doi: 10.1016/S1470-2045(18)30676-4. Epub 2018 Dec 18.
PubMed 30578023
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02066285
- Acronym / sponsor ID
- GEIS-32
- Keywords
- Solitary fibrous tumor, Extraskeletal myxoid chondrosarcoma, Unresectable, Locally advanced, Metastatic disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Grupo Espanol de Investigacion en SarcomasUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- 24 Mar 2023 (actual)
- First posted
- 19 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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; 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pazopanib | Experimental | Drug: PazopanibSingle arm of pazopanib 800 mg (2x400 mg or 4x200 mg) given as a single agent once daily continuously. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up.
- Age ≥ 18 years or legal age of consent if greater than 18 years.
- Histologic diagnosis of solitary fibrous tumor (stratum 1) or extraskeletal myxoid chondrosarcoma (stratum 2) (unresectable, locally advanced or metastatic disease) confirmed by central pathology review.
- Patients with metastatic tumor suitable for complete resection can be recruited. In absence of progressive disease these patients should be treated with the study drug for at least 6 months.
- For patients who have received previous anticancer treatments, progressive disease must be demonstrated within 6 months prior to enrollment.
Key exclusion criteria (21 listed)
- Prior malignancy, except patients who have had another malignancy and have been disease-free for 10 years, or those with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma.
- Central nervous system metastases at baseline, with the exception of patients who have previously-treated central nervous system metastases (surgery ± radiotherapy, radiosurgery, or gamma knife) and who meet both of the following criteria: a) are asymptomatic and b) have no requirement for steroids or enzyme-inducing anticonvulsants in prior 6-month time interval.
- Patients who have received previous antiangiogenic agents.
- Significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding.
- Significant gastrointestinal abnormalities that may affect absorption of investigational product.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PazopanibAlso: VotrientTreatment will continue until disease progression, development of unacceptable toxicity, non-compliance, withdrawal of consent by the patient or investigator decision. | Drug | Pazopanib |
Primary outcome
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.
4 secondary outcomes
Efficacy of pazopanib
Time frame: 48 weeks
Overall survival (OS)
Time frame: 72 weeks
Clinical benefit rate (CBR)
Time frame: 48 weeks
Long term safety profile of pazopanib
Time frame: 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Derived from this study: PubMed 35965642Napolitano A, Moura DS, Hindi N, Mondaza-Hernandez JL, Merino-Garcia JA, Ramos R, Dagrada GP, Stacchiotti S, Graziano F, Vincenzi B, Martin-Broto J. Expression of p53 as a biomarker of pazopanib efficacy in solitary fibrous tumours: translational analysis of a phase II trial. Ther Adv Med Oncol. 2022 Aug 6;14:17588359221116155. doi: 10.1177/17588359221116155. eCollection 2022.
- Derived from this study: PubMed 32066540Martin-Broto J, Cruz J, Penel N, Le Cesne A, Hindi N, Luna P, Moura DS, Bernabeu D, de Alava E, Lopez-Guerrero JA, Dopazo J, Pena-Chilet M, Gutierrez A, Collini P, Karanian M, Redondo A, Lopez-Pousa A, Grignani G, Diaz-Martin J, Marcilla D, Fernandez-Serra A, Gonzalez-Aguilera C, Casali PG, Blay JY, Stacchiotti S. Pazopanib for treatment of typical solitary fibrous tumours: a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2020 Mar;21(3):456-466. doi: 10.1016/S1470-2045(19)30826-5. Epub 2020 Feb 14.
- Derived from this study: PubMed 31331701Stacchiotti S, Ferrari S, Redondo A, Hindi N, Palmerini E, Vaz Salgado MA, Frezza AM, Casali PG, Gutierrez A, Lopez-Pousa A, Grignani G, Italiano A, LeCesne A, Dumont S, Blay JY, Penel N, Bernabeu D, de Alava E, Karanian M, Morosi C, Brich S, Dagrada GP, Vallacchi V, Castelli C, Brenca M, Racanelli D, Maestro R, Collini P, Cruz J, Martin-Broto J. Pazopanib for treatment of advanced extraskeletal myxoid chondrosarcoma: a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2019 Sep;20(9):1252-1262. doi: 10.1016/S1470-2045(19)30319-5. Epub 2019 Jul 19.
- Derived from this study: PubMed 30578023Martin-Broto J, Stacchiotti S, Lopez-Pousa A, Redondo A, Bernabeu D, de Alava E, Casali PG, Italiano A, Gutierrez A, Moura DS, Pena-Chilet M, Diaz-Martin J, Biscuola M, Taron M, Collini P, Ranchere-Vince D, Garcia Del Muro X, Grignani G, Dumont S, Martinez-Trufero J, Palmerini E, Hindi N, Sebio A, Dopazo J, Dei Tos AP, LeCesne A, Blay JY, Cruz J. Pazopanib for treatment of advanced malignant and dedifferentiated solitary fibrous tumour: a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2019 Jan;20(1):134-144. doi: 10.1016/S1470-2045(18)30676-4. Epub 2018 Dec 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josefina Cruz, MD study director
Hospital Universitario de Canarias
Javier Martín, MD study director
Hospital Son Espases
Antonio López-Pousa, MD principal investigator
Hospital Sant Pau
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pazopanib in people with Solitary Fibrous Tumor and Extraskeletal Myxoid Chondrosarcoma, run by Grupo Espanol de Investigacion en Sarcomas at 7 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02066285, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023.