A phase II trial of pazopanib drug given to patients with solitary fibrous tumor (SFT) and extraskeletal myxoid chondrosarcoma (EMC) that cannot be removed with surgery or having metastasis

• Conditions: Patients with unresectable, locally advanced or metastatic solitary fibrous tumor (SFT) or extraskeletal myxoid chondrosarcoma (EMC); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-005456-15-ES
• Lead Sponsor: Grupo Español de Investigación en Sarcomas

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-27
• Last Update Posted: 12 May 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1.Patients must provide written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up. Informed consent must be obtained prior to start of the screening process. Procedures conducted as part of the patient?s routine clinical management (e.g. blood count, imaging tests, etc.) and obtained prior to signature of informed consent may be used for screening or baseline purposes as long as these procedures are conducted as specified in the protocol.

2.Age ? 18 years or legal age of consent if greater than 18 years.

3.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. Paraffin-embedded tumor tissue must be provided for all subjects for biomarker analysis before and (when feasible) after treatment with investigational product.

4.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.

5.For patients who have received previous anticancer treatments, progressive disease must be demonstrated within 6 months prior to enrollment.

6.Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

7.Measurable disease according to Choi (SFT) and RECIST 1.1 (EMC) criteria. Patients must have at least one measurable lesion (not in a previously irradiated area). If the only measurable disease is in a previously irradiated area, documented progression should exist after radiotherapy within the 6 months prior to enrollment.

8.Patients could have received a maximum of 4 lines of chemotherapy for metastatic disease prior to trial enrollment.

9.Patients must be able to swallow and retain the study drug.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1.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.

2.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.

3.Patients who have received previous antiangiogenic agents.

4.Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:

?Active peptic ulcer disease
?Known intraluminal metastatic lesion(s) with risk of bleeding
?Inflammatory bowel disease (e.g. ulcerative colitis, Chrohn?s disease), or other gastrointestinal conditions with increased risk of perforation
?History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment

5.Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:

?Malabsorption syndrome
?Major resection of the stomach or small bowel

6.Corrected QT interval (QTc) > 480 msecs.

7.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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified