Study of the efficacy 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).MedDRA version: 15.1Level: HLGTClassification code 10041299Term: Soft tissue sarcomasSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-005456-15-FR
- Lead Sponsor
- Grupo Español de Investigación en Sarcomas
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 70
- Written informed consent
- Age = 18 years
- Centrally confirmed histologic diagnosis of SFT or EMC
- ECOG PS <2
- Measurable disease
- Maximum of 4 prior metastatic chemotherapy lines
- Able to swallow
- Adequate laboratory examinations
- Effective contraception
- Adequate Left Ventricular Ejection Fraction
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
- Prior malignancy
- active Central Nervous System metastasis
- Prior antiangiogenic agents
- Clinically significant gastrointestinal abnormalities with bleeding or malabsorption risk
- QTc > 480 msec
- History of major cardiovascular condition
- Poorly controlled hypertension
- bleeding risk or tumor lesions associated with bleeding risk
- concomittant prohibited treatment
- ongoing previous toxicity
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method