Evaluation of Votrient in Angiosarcoma
Condition: Angiosarcoma
MeSH terms: Hemangiosarcoma
Intervention: Pazopanib + Paclitaxel
Intervention description: pazopanib in combination with paclitaxel in the treatment of patients with advanced or metastatic angiosarcoma.
Intervention MeSH terms: Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Open-label phase II trial investigating the efficacy and safety of the investigational
      combination of pazopanib and paclitaxel.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

          -  Age ≥ 18 years

          -  Life expectancy > 3 months

          -  Ability to swallow tablets

          -  Histological confirmed angiosarcoma, primary and secondary angiosarcoma (e.g.
             radiation-induced or angiosarcoma in chronical lymphedema) are eligible.

          -  Tumor must be locally advanced (unresectable) or metastatic. A progression must be
             documented within a 6-month period prior to screening.

          -  Eastern Cooperative Oncology Group performance status ≤ 2

          -  At least one measurable skin lesion or one measurable radiological (CT or MRI) target
             lesion (RECIST 1.1)

          -  Adequate organ system function as described in protocol

          -  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 negative
             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 30 days after
             the last dose of study drug.

          -  All sexually active male patients must agree to use adequate methods of birth control
             (see protocol) throughout the study and for 30 days after the last dose of study drug.

        Exclusion Criteria:

          -  Patients who need an active treatment for another malignant disease other than
             angiosarcoma

          -  Prior treatment with taxane within the last 12 months before study entry

          -  History or clinical evidence of central nervous system (CNS) metastases or
             leptomeningeal sarcomatosis.(see protocol)

          -  Clinically significant gastrointestinal abnormalities that may increase the risk for
             gastrointestinal bleeding (see protocol)

          -  Clinically significant gastrointestinal abnormalities that may affect absorption of
             investigational product (see protocol)

          -  Presence of uncontrolled infection

          -  QT prolongation interval (QTc) > 480 msec.

          -  Clinically significant cardiovascular disorders within the past 6 months

          -  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

          -  Poorly controlled hypertension (see protocol)

          -  Evidence of active bleeding or bleeding diathesis

          -  Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels

          -  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

          -  Women who are pregnant or breast feeding

          -  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

          -  Chemotherapy or radiotherapy within 14 days before start of study medication

          -  Any ongoing toxicity from prior anti-cancer therapy that is > grade 1 and/or that is
             progressing in severity, except alopecia