Status:
TERMINATED
Evaluation of Votrient in Angiosarcoma
Lead Sponsor:
Heidelberg University
Collaborating Sponsors:
Universitätsmedizin Mannheim
Helios Klinikum Berlin-Buch
Conditions:
Angiosarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Open-label phase II trial investigating the efficacy and safety of the investigational combination of pazopanib and paclitaxel.
Detailed Description
Open-label phase II trial investigating the efficacy and safety of the investigational combination of pazopanib and paclitaxel.This multi-center, open-label, prospective, single arm phase II study was...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2020
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT02212015
Start Date
July 1 2014
End Date
July 1 2020
Last Update
March 22 2022
Active Locations (10)
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1
Universitätsklinik Graz
Graz, Austria
2
Universitätsklinik Wien
Vienna, Austria
3
Helios-Klinikum Bad Saarow
Bad Saarow, Germany
4
Helios Klinikum Berlin-Buch
Berlin, Germany