Advanced and relapsed angiosarcoma MedDRA version: 18.1 Level: LLT Classification code 10002481 Term: Angiosarcoma stage unspecified System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 18.1 Level: PT Classification code 10072814 Term: Breast angiosarcoma metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 18.1 Level: PT Classification code 10072813 Term: Bre
Conditions
Interventions
Trade Name: Votrient 400 mg (Studienware)
Product Name: Votrient
Product Code: EMEA/H/C/001141
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: PAZOPANIB
CAS Number: 444731-52-6
Concentrat
Sponsors
University of Heidelberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects 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. Note: Procedures conducted as part of the subject’s routine clinical management (e.g., blood count, imaging studies) and obtained prior to signing informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol. 2. Age = 18 years 3. Life expectancy > 3 months 4. Ability to swallow tablets 5. Histological confirmed angiosarcoma, primary and secondary angiosarcoma (e.g. radiation-induced or angiosarcoma in chronical lymphedema) are eligible. 6. Tumor must be locally advanced (unresectable) or metastatic. A progression must be documented within a 6-month period prior to screening. 7. ECOG performance status = 2 8. At least one measurable skin lesion or one measurable radiological (CT or MRI) target lesion (RECIST 1.1) 9. Adequate organ system function as described in protocoll 10. A female is eligible to enter and participate in this study if she is either of non childbearing potential (defined in protocol) or childbearing potential with negativ pregnancy test within 2 weeks prior to the first dose of study drug and agrees to use adequate contraception (as defined in protocol) during the study and for 6 month after the last dose of study drug. 11. All sexually active male patients must agree to use adequate methods of birth control (see protocol) throughout the study and for 6 month after the last dose of 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 22 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 22
Exclusion criteria
Exclusion criteria: 1. Patients who need an active treatment for another malignant disease other than angiosarcoma 2. Prior treatment with a taxan within the last 12 months before study entry 3. History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal sarcomatosis 4. Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding 5. Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product 6. Presence of uncontrolled infection 7. QT prolongation interval (QTc) > 480 msecs 8. Clinically significant cardiovascular discorders within the past 6 months 9. 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 10. Poorly controlled hypertension (see protocol) 11. Evidence of active bleeding or bleeding diathesis 12. Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels 13. Uncontrolled seizures, disorders of the CNS or psychiatric disorders which may put patient safety at risk, prevent giving informed consent or impact the patient's compliance with the use of study medication 14. Women who are pregnant or breast feeding 15. Patients who are not able or not willing to interrupt the intake of medications that are not allowed according to study protocol for at least 14 days before start of study medication and for the whole study period 16. Chemotherapy or radiotherapy within 14 days before start of study medication 17. Any ongoing toxicity from prior anti-cancer therapy that is > grade 1 and/or that is progressing in severity, except alopecia Please note: Any treatment with Pazopanib before study entry is NOT allowed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate progression free survival at 6 month (PFS-R);Secondary Objective: to evaluate response rate according to RECIST 1.1, overall survival and assessment of safety aspects;Primary end point(s): rate of progression free survival at 6 month (PFS-R);Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall survival (OS) Response Rate (RR rate according to RECIST Version 1.1) Toxicity (according to CTCAE, Version 4.0);Timepoint(s) of evaluation of this end point: during study is running | — |
Countries
Austria, Germany
Contacts
Public ContactGISG Regulatory Department
University of Heidelberg, Medical Faculty
Outcome results
None listed